NA 03.010.064Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982067388), received between Feb 22, 2017 and Sep 22, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (17 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862732 ↗
• MalfunctionFeb 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR PROXIMAL HUMERUS FRACTURES. DURING THE PROCEDURE, ONE DISTAL HOLE WAS DRILLED AND CONFIRMED BY IMAGING TO HAVE PASSED THROUGH THE NAIL HOLE. WHILE DRILLING ANOTHER HOLE, THE DRILL BIT INTERFERED WITH THE NAIL. ALTHOUGH RECOVERY METHODS SUCH AS LIGHTLY TAPPING WITH A PLASTIC HAMMER, CREATING A PILOT HOLE WITH A K-WIRE, AND MANUALLY FINE-TUNING THE SLEEVE WERE ATTEMPTED, THE DRILL BIT WOULD NOT PASS THROUGH THE NAIL. AS A RESULT, NO SCREW WAS INSERTED INTO THAT HOLE AND FIXATION WAS PERFORMED WITH ONE DISTAL LOCKING SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400880 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF SURGERY FOR DIAPHYSEAL FRACTURES OF THE HUMERUS. SINCE THE SLEEVE MARKER WAS ALREADY PEELING OFF WHEN IT ARRIVED, AND THE CONDITION HAS NOT CHANGED POST-SURGERY, THE HOSPITAL STATES THAT THE MARKER DID NOT COME OFF DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350407 ↗
• MalfunctionJul 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JUNE 28, 2024, THE PATIENT UNDERWENT ORIF SURGERY FOR FRACTURE OF THE PROXIMAL HUMERUS ON PROXIMAL HUMERUS WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, DURING THE DRILLING OF THE DISTAL LATERAL STOP, THE DRILL BITS IN QUESTION WERE NOT SHARP ENOUGH, ALTHOUGH THE PATIENT'S BONE QUALITY WAS ALSO A FACTOR. THE SLEEVE IN QUESTION WAS INSERTED AND DRILLED UNTIL IT CONTACTED THE BONE, AVOIDING THE SOFT TISSUE, BUT THE DRILL INTERFERED IN THE G-HOLE. THE IMAGE CONFIRMED THAT THE DRILL TIP REACHED INSIDE THE NAIL HOLE, SO WHEN THE DRILL TIP WAS LIGHTLY TAPPED WITH A HAMMER, THE DRILL TIP PASSED THROUGH THE HOLE. FINALLY, WHEN INSERTING THE END CAP IN QUESTION, THE END CAP WAS REINSERTED SEVERAL TIMES, BUT IT DID NOT ENGAGE PROPERLY, AND THE SURGEON DECIDED TO CLOSE THE WOUND WITH THE CAP ENGAGED AT AN ANGLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) 8.0MM/3.2MM DRILL SLEEVE 200MM. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19810758 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. THIS IS A REPORT OF INTRAOPERATIVE INTERFERENCE BETWEEN THE DRILL TIP AND THE INTRAMEDULLARY NAIL. DURING THE SURGERY, AFTER INSERTION OF AN INTRAMEDULLARY NAIL AND PROXIMAL FIXATION, DISTAL ANTEROLATERAL SCREW FIXATION WAS PERFORMED. DURING DISTAL POSTEROLATERAL SCREW FIXATION, THE DRILL TIP INTERFERED WITH THE INTRAMEDULLARY NAIL. AFTER INTERFERENCE, BECAUSE OF THE POSSIBILITY OF FORCE ON THE SLEEVE DUE TO SOFT TISSUE TENSION, A SMALL AMOUNT OF SKIN INCISION AND DEPLOYMENT WAS ADDED. ATTEMPTED TO DRILL AGAIN BUT AGAIN THERE WAS INTERFERENCE. THE SURGEON PULLED OUT THE DRILL AND TRIED TO DRILL A HOLE WITH A SMALLER 3.0 MM DIAMETER K-WIRE, BUT THE INTERFERENCE HAPPENED AGAIN. THE CONNECTION BETWEEN THE INTRAMEDULLARY NAIL AND THE HANDLE AND THE CONNECTION BETWEEN THE AIMING ARM AND THE INSERTION HANDLE WERE CHECKED AGAIN FOR LOOSENESS. THERE WAS NO INTERFERENCE DURING THE DRY CHECK BEFORE INSERTION. WHEN CHECKED FROM THE SIDE WITH THE SLEEVE IN PLACE, IT WAS CLEARLY OBSERVED THAT THE SLEEVE WAS DISPLACED BACKWARD. THE SURGEON CONSIDERED REMOVING THE AIMING ARM AND PERFORMING THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725813 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. THIS IS A REPORT OF INTRAOPERATIVE INTERFERENCE BETWEEN THE DRILL TIP AND THE INTRAMEDULLARY NAIL. DURING THE SURGERY, AFTER INSERTION OF AN INTRAMEDULLARY NAIL AND PROXIMAL FIXATION, DISTAL ANTEROLATERAL SCREW FIXATION WAS PERFORMED. DURING DISTAL POSTEROLATERAL SCREW FIXATION, THE DRILL TIP INTERFERED WITH THE INTRAMEDULLARY NAIL. AFTER INTERFERENCE, BECAUSE OF THE POSSIBILITY OF FORCE ON THE SLEEVE DUE TO SOFT TISSUE TENSION, A SMALL AMOUNT OF SKIN INCISION AND DEPLOYMENT WAS ADDED. ATTEMPTED TO DRILL AGAIN BUT AGAIN THERE WAS INTERFERENCE. THE SURGEON PULLED OUT THE DRILL AND TRIED TO DRILL A HOLE WITH A SMALLER 3.0 MM DIAMETER K-WIRE, BUT THE INTERFERENCE HAPPENED AGAIN. THE CONNECTION BETWEEN THE INTRAMEDULLARY NAIL AND THE HANDLE AND THE CONNECTION BETWEEN THE AIMING ARM AND THE INSERTION HANDLE WERE CHECKED AGAIN FOR LOOSENESS. THERE WAS NO INTERFERENCE DURING THE DRY CHECK BEFORE INSERTION. WHEN CHECKED FROM THE SIDE WITH THE SLEEVE IN PLACE, IT WAS CLEARLY OBSERVED THAT THE SLEEVE WAS DISPLACED BACKWARD. THE SURGEON CONSIDERED REMOVING THE AIMING ARM AND PERFORMING THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725615 ↗
• MalfunctionFeb 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT UNDERWENT AN ORIF SURGERY WITH MHN IMPLANTS FOR A FRACTURE OF THE LEFT PROXIMAL HUMERUS. THE SURGEON USED A DRILL SLEEVE FOR THE DISTAL WHEN HE DRILLED THE PROXIMAL AP HOLE. GAPS BETWEEN THE DRILL SLEEVE AND THE HOLE CAUSED THE DRILL HOLE TO SHIFT AND THE DRILL BIT INTERFERED WITH THE NAIL. THE SURGEON DRILLED MANUALLY AT THE SURGEON¿S DISCRETION AND SUCCEEDED IN MAKING A HOLE. THE SCREW WAS INSERTED SUCCESSFULLY. WHEN THE SURGEON WAS INSERTING DISTAL LOCKING SCREWS, DRILLING WAS DONE SMOOTHLY FOR ONE OF THE LOCKING SCREWS, AND THE DRILL BIT WAS LEFT FOR FIXATION. HOWEVER, ANOTHER DRILL BIT ALSO INTERFERED WITH THE NAIL WHEN IT WAS USED TO DRILL A HOLE FOR A 2ND DISTAL LOCKING SCREW. THE SURGEON DRILLED MANUALLY FOR THE HOLE AND INSERTED THE DISTAL LOCKING SCREW SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FRAGMENTS WERE LEFT IN THE PATIENT, THE SURGEON CONFIRMED THIS VIA X-RAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN 8.0MM/3.2MM DRILL SLEEVE 200MM. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687620 ↗
• MalfunctionFeb 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT UNDERWENT AN ORIF SURGERY WITH MHN IMPLANTS FOR A FRACTURE OF THE LEFT PROXIMAL HUMERUS. THE SURGEON USED A DRILL SLEEVE FOR THE DISTAL WHEN HE DRILLED THE PROXIMAL AP HOLE. GAPS BETWEEN THE DRILL SLEEVE AND THE HOLE CAUSED THE DRILL HOLE TO SHIFT AND THE DRILL BIT INTERFERED WITH THE NAIL. THE SURGEON DRILLED MANUALLY AT THE SURGEON¿S DISCRETION AND SUCCEEDED IN MAKING A HOLE. THE SCREW WAS INSERTED SUCCESSFULLY. WHEN THE SURGEON WAS INSERTING DISTAL LOCKING SCREWS, DRILLING WAS DONE SMOOTHLY FOR ONE OF THE LOCKING SCREWS, AND THE DRILL BIT WAS LEFT FOR FIXATION. HOWEVER, ANOTHER DRILL BIT ALSO INTERFERED WITH THE NAIL WHEN IT WAS USED TO DRILL A HOLE FOR A 2ND DISTAL LOCKING SCREW. THE SURGEON DRILLED MANUALLY FOR THE HOLE AND INSERTED THE DISTAL LOCKING SCREW SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FRAGMENTS WERE LEFT IN THE PATIENT, THE SURGEON CONFIRMED THIS VIA X-RAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN 8.0MM/3.2MM DRILL SLEEVE 200MM. THIS IS REPORT 3 OF 6 FOR :(B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687612 ↗
• MalfunctionFeb 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 29-JANUARY-2024 WHILE PERFORMING A DEMO FOR STAFF, IT WAS DISCOVERED THAT THE 8.0/4.2MM DRILL SLEEVE WOULD NOT FIT DOWN THE 12.0/8.0MM PROTECTION SLEEVE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN 8.0MM/3.2MM DRILL SLEEVE 200MM THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685234 ↗
• MalfunctionJan 16, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SLEEVES ARE BENT FROM NORMAL WEAR AND TEAR. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) 8.0MM/3.2MM DRILL SLEEVE 200MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519155 ↗
• MalfunctionJun 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2022, THE 12MM PROTECTION SLEEVE, DRILL SLEEVE AND TROCAR GOT STUCK IN THE TARGETING ARM OF THE ADOLESCENT LATERAL ENTRY FEMORAL NAIL. SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF 30 MINUTES. THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 8.0MM/3.2MM DRILL SLEEVE 200MM THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653887 ↗
• MalfunctionApr 21, 2022Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY USING THE MULTILOC HUMERAL NAIL. DUE TO COVID 19 RESTRICTIONS SALES REPRESENTATIVE HAD TO COMMUNICATE REMOTELY DURING THE SURGERY AND WHICH CAUSED MISCOMMUNICATION AS WELL AS CONNECTION ISSUE RESULTING IN THE SURGEON USING INCORRECT INSTRUMENT DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 8.0MM/3.2MM DRILL SLEEVE 200MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14174978 ↗
• MalfunctionNov 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT THE OSTEOSYNTHESIS SURGERY FOR PROXIMAL HUMERAL SHAFT FRACTURE WITH THE WITH MULTILOC HUMERAL NAIL (MHN) SYSTEM. DURING DRILLING OF THE DISTAL HOLE, TWO (2) OF THE MULTILOC HUMERAL NAIL INTERFERED WITH IM NAILS. THE SURGEON CONTINUED DRILLING WITH FINE ADJUSTMENTS, AND FELT A LITTLE UNCOMFORTABLE WITH THE DRILL SLEEVE IN QUESTION. THE SURGEON USED ANOTHER DRILL SLEEVE INSTEAD, AND SUCCEEDED IN DRILLING WITHOUT ANY PROBLEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THIS REPORT INVOLVES ONE (1) 8.0MM/3.2MM DRILL. SLEEVE 200MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779199 ↗
• MalfunctionNov 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OSTEOSYNTHESIS SURGERY FOR PROXIMAL HUMERAL SHAFT FRACTURE WITH THE WITH MULTILOC HUMERAL NAIL (MHN) SYSTEM. DURING DRILLING OF THE DISTAL HOLE, TWO (2) OF THE MULTILOC HUMERAL NAIL INTERFERED WITH IM NAILS. THE SURGEON CONTINUED DRILLING WITH FINE ADJUSTMENTS, AND FELT A LITTLE UNCOMFORTABLE WITH THE DRILL SLEEVE IN QUESTION. THE SURGEON USED ANOTHER DRILL SLEEVE INSTEAD, AND SUCCEEDED IN DRILLING WITHOUT ANY PROBLEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THIS REPORT INVOLVES ONE (1) 8.0MM/3.2MM DRILL SLEEVE 200MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779108 ↗
• MalfunctionMay 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR THE PROXIMAL HUMERAL FRACTURE WITH THE INSTRUMENTS AND NAIL IN QUESTION. THE SURGEON CHECKED THE NAIL SIZE TO BE USED BEFORE SURGERY. THE SURGEON WAS PLANNING TO USE A 9.5 MM NAIL, BUT IN THE PREOPERATIVE IMAGE, THE MEDULLARY CAVITY WAS UNEXPECTEDLY SMALL, SO HE USED AN 8.0 MM NAIL. THE INTRAMEDULLARY NAIL WAS INSERTED THROUGH THE GUIDE ROD, BUT THE MEDULLARY CAVITY WAS TOO NARROW TO GET INSIDE. THE SURGEON USED A HAMMER BECAUSE THE NAIL COULD NOT BE INSERTED (SALES ADVISED AGAINST IT. THE HOSPITAL DID NOT HAVE A REAMER). THE NAIL COULD BE INSERTED UP TO THE SPECIFIED POSITION. THE SURGEON INSERTED THREE PROXIMAL SCREWS AND MOVED ON TO INSERT THE DISTAL SCREWS, BUT THE DRILL BIT INTERFERED WITH THE NAIL, AND IT DID NOT GO IN, SO THE SURGEON REMOVED THE DRILL BIT, TAP IT WITH A HAMMER, LET IT GO THROUGH THE INTRAMEDULLARY NAIL, RE-ATTACH IT TO THE DRILL BIT, AND DRILL TO THE OPPOSITE SIDE. AFTER MEASURING, A SCREW WAS INSERTED. BECAUSE THE DRILL BIT INTERFERED ON THE PROXIMAL SIDE AS WELL, THE SAME PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894854 ↗
• MalfunctionMay 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR THE PROXIMAL HUMERAL FRACTURE WITH THE INSTRUMENTS AND NAIL IN QUESTION. THE SURGEON CHECKED THE NAIL SIZE TO BE USED BEFORE SURGERY. THE SURGEON WAS PLANNING TO USE A 9.5 MM NAIL, BUT IN THE PREOPERATIVE IMAGE, THE MEDULLARY CAVITY WAS UNEXPECTEDLY SMALL, SO HE USED AN 8.0 MM NAIL. THE INTRAMEDULLARY NAIL WAS INSERTED THROUGH THE GUIDE ROD, BUT THE MEDULLARY CAVITY WAS TOO NARROW TO GET INSIDE. THE SURGEON USED A HAMMER BECAUSE THE NAIL COULD NOT BE INSERTED (SALES ADVISED AGAINST IT. THE HOSPITAL DID NOT HAVE A REAMER). THE NAIL COULD BE INSERTED UP TO THE SPECIFIED POSITION. THE SURGEON INSERTED THREE PROXIMAL SCREWS AND MOVED ON TO INSERT THE DISTAL SCREWS, BUT THE DRILL BIT INTERFERED WITH THE NAIL, AND IT DID NOT GO IN, SO THE SURGEON REMOVED THE DRILL BIT, TAP IT WITH A HAMMER, LET IT GO THROUGH THE INTRAMEDULLARY NAIL, RE-ATTACH IT TO THE DRILL BIT, AND DRILL TO THE OPPOSITE SIDE. AFTER MEASURING, A SCREW WAS INSERTED. BECAUSE THE DRILL BIT INTERFERED ON THE PROXIMAL SIDE AS WELL, THE SAME PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894646 ↗
• MalfunctionMar 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE INSERTION HANDLE WITH THE PROTECTION SLEEVE AND DRILL SLEEVE IN PLACE WAS AIMING OFF WHEN PLACING THE SCREW IN THE 120-DEGREE LOCK OPTION. THERE WAS PLAY IN THE SLEEVE/HANDLE. THE LONG 3.2MM DRILL BIT WENT THROUGH FINE AND CENTERED IN THE NAIL 120-DEGREE HOLE. TO COMPLETE THE PROCEDURE THE NAIL WAS LOCKED IN THE DYNAMIC SLOT WITH A 4.0 MM SCREW AND THEN THE 120 DEGREE WAS SCREW WAS PLACED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) 8.0MM/3.2MM DRILL SLEEVE 200MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590730 ↗
• InjuryDec 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR PROXIMAL HUMERUS FRACTURE WITH THE MULTILOC HUMERAL NAILING (MHN) SYSTEM. DURING THE DISTAL SCREW INSERTION, THE DRILL BIT SLIGHTLY INTERFERED WITH THE NAIL AND THE SURGEON HAD DIFFICULTY IN PASSING THE DEPTH GAUGE THROUGH THE DEVICES, BUT HE COULD CONTINUE THE SURGERY AND CLOSE THE INCISION. JUST AFTER THE SURGERY, THE SURGEON CONFIRMED BY X-RAYS THAT THE DISTAL TWO (2) SCREWS WERE NOT PASSED THROUGH THE NAIL. THE SCREWS WERE INSERTED AT POSTERIOR POSITION. THE SURGEON REMOVED THE SCREWS AND TRIED TO RE-INSERT THE SCREWS AGAIN. THE MOST DISTAL SCREW COULD BE INSERTED SUCCESSFULLY, BUT THE OTHER SCREW COULD NOT BE INSERTED BECAUSE THE BONE STATUS WAS BAD DUE TO REPEATED DRILLING AND SCREW INSERTION. FINALLY, ONE (1) SCREW WERE INSERTED AT DISTAL HOLE AND THE SURGEON GAVE UP INSERTING THE OTHER SCREW AND THE SURGERY WAS COMPLETED WITH FORTY (40) MINUTES DELAY. THE SURGEON COMMENTED THAT THE NAIL IS THICK AND OCCUPIED LARGE SPACE AND THE DISTAL SCREW WAS FIXED FIRMLY. SURGEON COMMENTED THAT THE INSERTION I

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10994509 ↗
• InjuryDec 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR PROXIMAL HUMERUS FRACTURE WITH THE MULTILOC HUMERAL NAILING (MHN) SYSTEM. DURING THE DISTAL SCREW INSERTION, THE DRILL BIT SLIGHTLY INTERFERED WITH THE NAIL AND THE SURGEON HAD DIFFICULTY IN PASSING THE DEPTH GAUGE THROUGH THE DEVICES, BUT HE COULD CONTINUE THE SURGERY AND CLOSE THE INCISION. JUST AFTER THE SURGERY, THE SURGEON CONFIRMED BY X-RAYS THAT THE DISTAL TWO (2) SCREWS WERE NOT PASSED THROUGH THE NAIL. THE SCREWS WERE INSERTED AT POSTERIOR POSITION. THE SURGEON REMOVED THE SCREWS AND TRIED TO RE-INSERT THE SCREWS AGAIN. THE MOST DISTAL SCREW COULD BE INSERTED SUCCESSFULLY, BUT THE OTHER SCREW COULD NOT BE INSERTED BECAUSE THE BONE STATUS WAS BAD DUE TO REPEATED DRILLING AND SCREW INSERTION. FINALLY, ONE (1) SCREW WERE INSERTED AT DISTAL HOLE AND THE SURGEON GAVE UP INSERTING THE OTHER SCREW AND THE SURGERY WAS COMPLETED WITH FORTY (40) MINUTES DELAY. THE SURGEON COMMENTED THAT THE NAIL IS THICK AND OCCUPIED LARGE SPACE AND THE DISTAL SCREW WAS FIXED FIRMLY. SURGEON COMMENTED THAT THE INSERTION I

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10994454 ↗
• MalfunctionJun 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE PROXIMAL HUMERAL FRACTURE WAS PERFORMED WITH AN UNKNOWN MULTILOC HUMERAL NAIL (MHN). DURING DISTAL LOCKING, WHEN THE SURGEON DRILLED ONE OF THE HOLE DISTAL HOLE WHICH WAS MORE PROXIMAL, THE DRILL BIT INTERFERED WITH AN UNKNOWN PROXIMAL SCREW. THE SURGEON DRILLED AND INSERTED AN UNKNOWN SCREW INTO THE MOST DISTAL HOLE FIRST. THEN, THE SURGEON CHECKED THE POSITION OF THE INSTRUMENTS BY X-RAYS AND FOUND THE UNKNOWN DRILL POINTED A RATHER POSTERIOR DIRECTION WHILE USING THE AIMING ARM. THUS, THE SURGEON ADJUSTED THE DRILL SLEEVE AND COULD DRILL WITHOUT INTERFERENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN MULTILOC HUMERAL NAIL (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1) AND UNKNOWN DISTAL LOCKING SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 8.0MM/3.2MM DRILL SLEEVE 200MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703511 ↗
• MalfunctionApr 12, 2017Failure to Align; Failure to Align

  (B)(6) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT THE DRILL SLEEVE, DRILL GUIDE, AND DRILL BIT DID NOT LINE UP WITH THE HOLES IN THE NAIL DURING A FRACTURE FEMUR PROCEDURE ON (B)(6) 2017. THE CONSTRUCT WHICH CONSISTED OF THE AIMING ARM, INSERTION HANDLE, CONNECTING SCREW, DRILL SLEEVE, DRILL GUIDE, AND DRILL BIT WAS CHECKED WITH THE NAIL PRIOR TO DRILLING AND EVERYTHING LINED UP. THE NAIL WAS INSERTED. DURING DRILLING, IT WAS FOUND THAT THE THREE DEVICES (DRILL SLEEVE, DRILL GUIDE, AND DRILL BIT) DID NOT ALIGN PROPERLY WITH THE HOLES IN THE NAIL. AFTER SEVERAL FAILED ATTEMPTS, SURGEON HAD TO DRILL FREEHANDEDLY. THE SAME NAIL WAS IMPLANTED. THERE WAS A TWENTY MINUTES SURGICAL DELAY DUE TO THE SEVERAL ATTEMPTS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. PATIENT OUTCOME/STATUS WAS REPORTED AS STABLE. NO PATIENT HARM REPORTED. THE HOSPITAL BELIEVED THAT THE DRILL SLEEVE WAS NOT FAR IN ENOUGH CAUSING THE DRILL BIT TO BE PUSHED DOWN BY THE SOFT TISSUE. IT APPEARS THAT THE EQUIPMENTS WERE MISUSED BY THE SURGEON IN THE CASE. THE HOSPITAL DOES NOT THINK THAT THERE WERE ANY ISSUES WITH THE DEVICES. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION. SINCE THE DRILL SLEEVE, DRILL GUIDE,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6485835 ↗
• MalfunctionMar 16, 2017Fitting Problem; Fitting Problem

  SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY TO TREAT PROXIMAL HUMERAL FRACTURE ON (B)(6) 2017, THE SURGEON ATTEMPTED TO DRILL THE DISTAL HOLE BUT THE NAIL INTERFERED WITH TWO (2) BITS AND THE TWO (3) ASSOCIATED PROTECTION SLEEVES WOULD NOT COME OFF AND COULD NOT BE HELD DOWN. THE SURGEON ATTEMPTED THE FOLLOWING TO COMPLETE THE PROCEDURAL STEP: DRILLING WITHOUT PUSHING SLEEVE OR DRILL; DRILLING BY PUSHING THE DRILL WHEN DRILL INTERFERED WITH NAIL; HAMMERED AS DRILL INTERFERED WITH NAIL; TOOK INNER CYLINDER OFF AS DRILL INTERFERED WITH NAIL; AND PRE-DRILLED USING K-WIRE2.5. THE ABOVE ATTEMPTS FAILED SO THE SURGEON GAVE UP INSERTING A SCREW IN THE DISTAL HOLE OF THE NAIL. THE SURGEON INSERTED SCREWS IN THE PROXIMAL HOLE AND ASCENDING SCREW HOLE AND COMPLETED THE PROCEDURE. THE SURGERY WAS DELAYED FOR 15 MINUTES DUE TO THE COMPLAINT EVENT. THE SURGEON WAS NOT CONSIDERED TO BE SUCCESSFULLY COMPLETED BECAUSE THE SURGEON COULD NOT IMPLANT A SCREW IN THE DISTAL NAIL HOLE. THE PATIENT¿S POSTOPERATIVE STATUS WAS REPORTEDLY GOOD. ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED. THIS REPORT IS 7 OF 10 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6410745 ↗
• MalfunctionMar 16, 2017Fitting Problem; Fitting Problem

  SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY TO TREAT PROXIMAL HUMERAL FRACTURE ON (B)(6) 2017, THE SURGEON ATTEMPTED TO DRILL THE DISTAL HOLE BUT THE NAIL INTERFERED WITH TWO (2) BITS AND THE TWO (3) ASSOCIATED PROTECTION SLEEVES WOULD NOT COME OFF AND COULD NOT BE HELD DOWN. THE SURGEON ATTEMPTED THE FOLLOWING TO COMPLETE THE PROCEDURAL STEP: DRILLING WITHOUT PUSHING SLEEVE OR DRILL; DRILLING BY PUSHING THE DRILL WHEN DRILL INTERFERED WITH NAIL; HAMMERED AS DRILL INTERFERED WITH NAIL; TOOK INNER CYLINDER OFF AS DRILL INTERFERED WITH NAIL; AND PRE-DRILLED USING K-WIRE 2.5. THE ABOVE ATTEMPTS FAILED SO THE SURGEON GAVE UP INSERTING A SCREW IN THE DISTAL HOLE OF THE NAIL. THE SURGEON INSERTED SCREWS IN THE PROXIMAL HOLE AND ASCENDING SCREW HOLE AND COMPLETED THE PROCEDURE. THE SURGERY WAS DELAYED FOR 15 MINUTES DUE TO THE COMPLAINT EVENT. THE SURGEON WAS NOT CONSIDERED TO BE SUCCESSFULLY COMPLETED BECAUSE THE SURGEON COULD NOT IMPLANT A SCREW IN THE DISTAL NAIL HOLE. THE PATIENT¿S POSTOPERATIVE STATUS WAS REPORTEDLY GOOD. ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED. THIS REPORT IS 6 OF 10 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6410684 ↗
• InjuryFeb 22, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2017, DURING A SUPRAPATELLAR INSERTION OF A NAIL, THE DRILL BIT CONTACTED THE NAIL THROUGH THE AIMING ARM AND INSERTION HANDLE. HAVING MISSED THE LOCKING HOLE OF THE NAIL, THE DRILL BIT WAS BACKED OUT AND THE INNER SLEEVE WAS REMOVED. ADDITIONAL FLUOROSCOPY WAS USED TO LOCATE THE LOCKING HOLE OF THE NAIL. WITH THE INNER SLEEVE REMOVED, SURGEON WAS THEN ABLE TO ALIGN THE DRILL BIT WITH THE LOCKING HOLE OF THE NAIL. PROCEDURE WAS DELAYED APPROXIMATELY TWO MINUTES BUT WAS COMPLETED SUCCESSFULLY WITH NO HARM TO PATIENT. CONCOMITANT DEVICES REPORTED: 9 MM TITANIUM CANNULATED TIBIAL NAIL (PART# 04.034.349S, LOT# 9848027, QUANTITY 1), PROTECTION SLEEVE WITH FLATS FOR SUPRAPATELLAR (PART# 03.010.442, LOT# 7660447, QUANTITY 1). THIS REPORT IS FOR ONE (1) 8.0 MM/3.2 MM DRILL SLEEVE 200 MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6349589 ↗