MULTILOC 03.019.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10886982069450), received between Mar 16, 2017 and Sep 22, 2026 — classified as 4 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (33 reports).

2 other recalls cover devices cleared under the same FDA submission (K103002); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 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 50862688 ↗
• MalfunctionSep 9, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695655 ↗
• MalfunctionSep 9, 2026Device-Device Incompatibility

  It was reported an upper limb surgeon has said he has had the aiming arm and nail miss a couple of times now on Multiloc cases.Prior to the case yesterday we did check it all aligned but when doing the distal locking for a short nail the drill did hit. I suggested tightening up the connection screw but he felt it and said it was tight.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690497 ↗
• MalfunctionMay 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE TWO AIMING ARMS INCLUDED IN THE MULTILOC PROXIMAL HUMERAL NAILING SET ARE ALLEGED BY THE CUSTOMER AS CAUSING THE DRILL BIT FOR THE LOCKING SCREW (MULTILOC) TO MISS THE NAIL. THE SURGEON BELIEVES THAT THE AIMING ARM IS OFF AND SHOULD BE REPLACED. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142458 ↗
• 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 24400839 ↗
• MalfunctionJul 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE WHEN SLIDING A SLEEVE THROUGH THE DIRECTIONAL ARM TO PERFORM THE PROXIMAL AND DISTAL LOCKING, IT PASSED WITH GREAT DIFFICULTY THROUGH THE ARM HOLES AND REQUIRED A LOT OF FORCE TO ADVANCE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680256 ↗
• MalfunctionJun 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS WITH A MULTILOC NAIL FOR A FRACTURE OF THE PROXIMAL END OF THE LEFT HUMERUS. WHEN THE PRODUCTS WERE CHECKED BEFORE NAIL INSERTION, THE DRILL BIT SLIGHTLY INTERFERED WITH THE NAIL IN THE PROXIMAL HOLE. WHEN THE NAIL WAS REMOVED FROM THE DEVICES AND REASSEMBLED, THE INTERFERENCE IN HOLES A AND B WAS RESOLVED, BUT THE DRILL BIT SLIGHTLY INTERFERED WITH THE NAIL IN HOLES D, F, AND G. DRILLING WAS SUCCESSFULLY DONE WITHOUT INTERFERENCE BETWEEN THE DRILL BIT AND THE NAIL, AND SCREWS WERE ALSO SUCCESSFULLY INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233204 ↗
• MalfunctionJun 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OSTEOSYNTHESIS WITH A MULTILOC SHORT NAIL. DURING AN INTERFERENCE CHECK BEFORE IMPLANT INSERTION INTO THE BODY, A SCRUB NURSE POINTED OUT THAT THE DRILL BIT FELT A LITTLE LIKE IT WAS TOUCHING THE NAIL IN THE D-HOLE. THE INSTRUMENTS AND NAIL WERE REASSEMBLED FROM THE BEGINNING AGAIN, AND THE SURGEON PERFORMED AN INTERFERENCE CHECK AGAIN. THE INTERFERENCE IN THE D-HOLE WAS RESOLVED, BUT THE SURGEON POINTED OUT THAT THERE WAS A SLIGHT FEELING THAT THE DRILL BIT WAS TOUCHING THE NAIL IN THE G-HOLE. IT WAS DECIDED THAT INTERFERENCE COULD BE AVOIDED BY ADJUSTING THE DIRECTION OF DRILLING, AND THE NAIL WAS INSERTED AT THE SURGEON'S DISCRETION. DRILLING WAS PERFORMED PROXIMALLY AND DISTALLY WITHOUT INTERFERENCE WITH THE NAIL, THE SCREW WAS INSERTED, AND FIXATION WAS SUCCESSFULLY COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174586 ↗
• MalfunctionMay 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN TRYING TO INSERT THE CORRESPONDING SCREW, IT DEVIATES, PASSES OUTSIDE THE NAIL AND REMAINS ANCHORED IN THE BONE, SO IT MUST BE REMOVED WITH THE HELP OF PLIERS.

  Patient problems: Insufficient Information

  MAUDE report 21963481 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT THE ORIF SURGERY FOR HUMERUS PROXIMAL FRACTURE WITH THE MULTILOC NAIL. DURING THE PROCESS THAT INSERTING THE DISTAL LOCKING, THE NAIL FOR THE G HOLE PLACED MOST DISTAL PART COULD BE INSERTED WITH NO PROBLEM. HOWEVER, AT THE TIME OF DRILLING F HOLE, THE DRILL BIT GOT INTERFERED WITH THE NAIL. THE SURGEON RE-EXPANDED THE SOFT TISSUE AND INSERTED PROTECTION SLEEVE CAREFULLY TO NOT TO BE BENT. THEN THE SURGEON DRILLED WITHOUT INTERFERENCE AND INSERTED SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921861 ↗
• MalfunctionNov 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE PATIENT UNDERWENT OSTEOSYNTHESIS FOR FRACTURE OF THE UPPER CARPAL BONE ON PROXIMAL UPPER WRIST WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, AFTER INSERTION OF THE PROXIMAL SCREW, THE DISTAL ONE (PROXIMAL) WAS INSERTED SMOOTHLY, BUT ON THE SECOND (DISTAL), THE DRILL INTERFERED WITH THE NAIL IN QUESTION, AND ALTHOUGH THE TIP WAS IN, IT COULD NOT BE INSERTED EVEN AFTER CHANGING THE DIRECTION. SINCE ONLY ONE FIXATION WAS PERFORMED DISTALLY AND THE SECOND WAS ONLY A DRILL HOLE, THE RISK OF POSTOPERATIVE FRACTURE WAS A CONCERN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736041 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2024, THE AIMING ARM WAS NOT ACCURATE WITH SCREW INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 20440271 ↗
• MalfunctionAug 28, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH THE MHN FOR PROXIMAL HUMERUS FRACTURE. AFTER OPENING THE PACKAGE OF THE NAIL, THE DRILL BIT INTERFERED WITH THE NAIL OUTSIDE THE BODY DURING AT THE CHECK. DURING SURGERY, THE DRILL BIT INTERFERED WITH THE NAIL AGAIN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON REQUESTED THAT THE PRODUCT BE SHIPPED AFTER A THOROUGH INSPECTION FOR CARBON WEAR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091939 ↗
• MalfunctionAug 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, WHEN THE MULTILOC SYSTEM WAS USED FOR THE FIRST TIME TODAY AT THE HOSPITAL. THE DISTAL LOCKING DID NOT WORK PROPERLY BECAUSE THE DRILL DID NOT HIT THE HOLE THROUGH THE AIMING ARM. THIS CAUSED THE DRILL TO BECOME BLUNT. THE SCREW WAS BEING LEFT OUT BY THE SURGEON. THERE WERE NO FRAGMENTS GENERATED. THEREFORE, THE DRILL NEEDS TO BE EXCHANGED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20046983 ↗
• MalfunctionAug 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE EVENT OCCURRED DURING INTRA OP. THE OPERATION COULD BE PERFORMED SATISFACTORILY. THE SURGEONS WERE FORCED TO DISPENSE WITH ONE OF THE DISTAL LOCKS AS THE SCREW COULD NOT BE PLACED DUE TO THE 'DISTORTED' INSERTION HANDLE. THERE IS NO ALLEGATION AGAINST THE HUMEROUS NAIL OR THE DRILL BIT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980923 ↗
• 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 19726088 ↗
• MalfunctionFeb 2, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A MULTILOC PROCEDURES, THE DRILL BIT HIT THE NAIL FOR THE POSTERIOR, ANTERIOR AND DIRECT ANTERIOR SCREW. THE SLEEVES WERE TESTED BEFORE AND UNSURE WHAT HAPPENED. PERFECT CIRCLE PROCEDURE WAS PERFORMED PROXIMALLY. THERE WAS A PATIENT DELAY. IT WAS UNSURE THAT THE JIG WAS BENT OR NOT DUE TO ROTATING JIG INTRAOP, BUT SURGEON WANTS EVERYTHING REPLACED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) AIM ARM/LAT/F/MULTILOC PROXIMAL HUM NL THIS IS REPORT 2 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632801 ↗
• MalfunctionDec 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE ORIF WITH THE MULTILOC. DURING DRILLING, THE DRILL BIT INTERFERED WITH THE NAIL. AT FIRST, THREE MULTLOC SCREWS WERE INSERTED INTO THE PROXIMAL AREA. THEN, THE DISTAL LOCKING SCREW WAS INSERTED INTO THE LEVEL G HOLE. THE DRILL BIT AND THE SCREW WERE INTERFERED WITH THE NAIL AT THE LEVEL F HOLE. THE SURGEON CHECKED FOR LOOSENING ON THE CONNECTING SCREW AND THE AIMING ARM, AND THERE WERE NO PROBLEMS. HAMMERING WAS NOT PERFORMED FOR THIS SURGERY. THE SURGEON COMMENTED THAT HE FELT LIKE THE DRILL BIT WAS HITTING THE NAIL. THE DRILL BIT WENT THROUGH THE HOLE THROUGH THE AIMING ARM, THE DRILL SLEEVE, AND PROTECTION SLEEVE. HOWEVER, WHEN THE SCREW WAS INSERTED, IT WENT OUTSIDE THE NAIL. THE SURGEON DETERMINED THAT THE DRILL BIT DID NOT PASS THROUGH THE HOLE IN THE NAIL, SO THAT THE SURGEON MANUALLY DRILLED THE HOLE AND INSERTED IT. THE INSERTION OF THE DEVICES WAS NOT CHECKED BEFORE INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE ARE NO FRAGMENTS IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. THIS IS FOR AIM-ARM LAT F/MULTILOC PH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291551 ↗
• MalfunctionOct 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON OCTOBER 6, 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION (ORIF) SURGERY WITH THE MULTILOC HUMERAL NAIL IN QUESTION FOR A PROXIMAL RIGHT HUMERAL FRACTURE. THE DRILL BIT INTERFERED WITH THE NAIL IN QUESTION WHILE THE G HOLE WAS DRILLED AFTER THE A AND B SCREWS WERE INSERTED. THE IMAGE SHOWED THAT THE DRILL BIT GRAZED THE FRONT OF THE NAIL. THE SURGEON ADJUSTED THE HAND AND TRIED TO RECOVER IT; HOWEVER, IT WAS DIFFICULT TO CORRECT THE INITIAL DRILL HOLE. THEREFORE, THE SURGEON DECIDED NOT TO INSERT THE SCREW AND FIXED ONLY THE F HOLE AT THE DISTAL AREA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT THERE WAS NO PROBLEM WITH BONE FIXATION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18020130 ↗
• MalfunctionMar 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BIT AND THE SCREW DIDN´T ACHIEVE THE NAIL´S HOLE IN THE MULTILOC HUMERAL NAIL SYSTEM. THE SURGEON MISSED THE PROXIMAL POSTERIOR OBLIQUE HOLE AND THE DISTAL ANTERIOR OBLIQUE HOLE. THE AIMING ARM FOR PROXIMAL HUMERAL NAIL, THE INSERTION HANDLE, AND THE CONNECTING SCREW HAD BEEN USED. THE AIMING ARM WAS ON THE CORRECT SIDE (RIGHT SIDE). THE SURGERY HAS BEEN DELAYED 1 HOUR, AND THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635864 ↗
• MalfunctionFeb 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF FOR PROXIMAL HUMERUS FRACTURE WITH THE PRODUCTS IN QUESTION. PREOPERATIVE CHECKS WERE UNEVENTFUL. DURING THE SURGERY, ONE DISTAL TRANSVERSE STOP SCREW GOT OVER AND THE OTHER INTERFERED WITH THE NAIL. IT DID NOT APPEAR AS IF THE SURGEON WAS TAKING A TECHNIQUE THAT WOULD PUT A LOAD ON THE NAIL OR THE LATERAL STOP SLEEVE. THE SURGEON NOTED THAT HE WONDERED IF THE COMPANY WAS DOING ANYTHING TO IMPROVE THE ACCURACY OF THE DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) AIM-ARM LAT F/MULTILOC PHN THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417960 ↗
• InjuryJan 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION FOR THE PROXIMAL FRACTURE OF THE RIGHT HUMERUS. PROXIMAL A HOLE AND B HOLE WERE FIXED. DISTAL F HOLE WAS FIXED. THEN, WHEN THE SURGEON WAS DRILLING G HOLE, THE DRILL BIT INTERFERED WITH THE NAIL. ALTHOUGH THE SURGEON CONTINUED DRILLING WHILE APPLYING SLIGHT AXIAL PRESSURE, THE DRILL BIT DISENGAGED FORWARD. AFTER CHECKING THE CONNECTING SCREW AND THE AIMING ARM FOR LOOSENESS, SKIN INCISION AT G HOLE WAS EXTENDED. THE SLEEVE WAS REINSERTED WHILE DODGING THE SOFT TISSUE PART. ALTHOUGH DRILLING WAS PERFORMED WHILE CONTROLLING THE DRILL TO HEAD BACKWARD, THE DRILL HOLE DISLODGED ANTERIOR TO INTRAMEDULLARY NAIL. THE SURGEON REMOVED THE AIMING ARM, AND DRILLING WAS PERFORMED MANUALLY. THEN, THE SCREW WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)AIM-ARM LAT F/MULTILOC PHN. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 16241776 ↗
• MalfunctionNov 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH MULTILOC FOR THE PROXIMAL HUMERAL FRACTURE. DURING DRILLING FOR DISTAL LOCKING SCREW, THE DRILL INTERFERED WITH THE NAIL, AND THE SURGEON COULD NOT DO DRILLING. THERE WAS NO PROBLEM BEFORE DRILLING. THE CONNECTING SCREWS DID NOT LOOSEN. DRILLING FOR THE TWO DISTAL SCREW HOLES WAS NOT POSSIBLE DUE TO INTERFERENCE. THEREFORE, DRILLING WAS PERFORMED BY CHECKING THE MISALIGNMENT WITH THE HOLE THROUGH THE K-WIRE AND MANUALLY LOADING THE SLEEVE IN THAT DIRECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE SURGEON GUESSED THAT GOOD BONE QUALITY MAY HAVE CAUSED FLEXURE DUE TO LOADING OF THE NAIL AT THE CONNECTION BETWEEN THE ANTERIOR MARGIN OF THE ACROMION AND THE DEVICE DURING INSERTION VIA RI APPROACH. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) AIM-ARM LAT F/MULTILOC PHN. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837624 ↗
• MalfunctionAug 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE PROCEDURE THE PROXIMAL SCREW WAS NOT ALIGNED WITH THE NAIL. THE ISSUE CAUSED FORCED SCREWING WITH HAMMER AND FREEHAND. THERE WAS AN INCREASE OF THE NUMBER OF FLUOROSCOPY AND AN INCREASE OF RADIATION DOSE. THIS REPORT INVOLVES ONE (1) AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258034 ↗
• MalfunctionNov 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021 DURING AN UNKNOWN PROCEDURE, ONE (1) AIMING ARM, ONE (1) INSERTION HANDLE, AND ONE (1) UNKNOWN DISTAL SCREW WERE UNABLE TO ASSEMBLE CORRECTLY. THE HANDLE AND AIMING ARM MALFUNCTIONED AND MISSED THE NAIL AND WERE UNABLE TO USE THE DISTAL SCREW. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) AIM ARM/LAT/F/MULTILOC PROXIMAL HUM NL. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847290 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103002. One submission often covers many models, so check the product and lot details in each record.

• Z-2060-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu
• Z-2059-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu