MULTILOC 03.019.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10886982069436), received between Mar 16, 2017 and Sep 22, 2026 — classified as 6 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (32 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 41 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 50862709 ↗
• MalfunctionSep 9, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695550 ↗
• 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, it was all aligned but when doing the distal locking for a short nail the drill, it 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 50690254 ↗
• MalfunctionAug 3, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114871 ↗
• MalfunctionSep 3, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025. THE INSERTION HANDLE WAS MISSING A PEG AND THE AIMING ARM WOULD NOT LINE UP PROPERLY WITHOUT SPECIAL ATTENTION AND A DRILL ASSEMBLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952777 ↗
• 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 22233105 ↗
• 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 22174582 ↗
• MalfunctionMay 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON APRIL 16, 2025. DURING THE PROCEDURE, THE PROXIMAL LOCKING SCREW MISSED THE NAIL EVEN THOUGH THE AIMING ARM WAS USED. THE SCREW NEEDED TO BE REMOVED, BUT WAS VERY DIFFICULT TO REMOVE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIXTY MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986042 ↗
• MalfunctionMay 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A HUMERAL NAILING USING THE DEPUY SYNTHES MULTILOC HUMERAL NAIL SYSTEM THE SURGEON TRIED TO ROTATE THE NAIL BY TURNING THE INSERTION HANDLE AND THE NAIL BROKE AT THE PROXIMAL TIP AND THE INSERTION HANDLE WAS DAMAGED. NO FRAGMENTS WERE GENERATED. ANOTHER SET WAS OPENED TO USE. THERE WAS A 15 MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951334 ↗
• MalfunctionApr 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE AIMING ARM IS MISALIGNED. IT NO LONGER TARGETS THE NAIL CORRECTLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910076 ↗
• MalfunctionJan 31, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE MULTILOC INSERTION HANDLE IS MISSING A STABILIZING BOLT TO ATTACH TO THE AIMING ARM. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT. THE PATIENT DOES NOT REQUIRED ANY REVISION SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO OTHER MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284152 ↗
• MalfunctionOct 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEFECTIVE NAIL-HOLDING HOOP MAKING DISTAL LOCKING IMPOSSIBLE. THE PROCEDURE WAS EXTENDED BY THIRTY MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 20561681 ↗
• MalfunctionJul 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JUNE 20, 2024, DURING INSPECTION OF SOME MULTILOC HUMERAL NAIL INSTRUMENTS, IT WAS DETERMINED THAT THE INSERTION HANDLE AND THE AIMING ARM, WHICH ARE TWO COMPONENTS THAT ARE DESIGNED TO CONNECT SECURELY TO EACH OTHER WHEN IN USE, WOULD ONLY CONNECT CORRECTLY WHEN THE AIMING ARM WAS CONNECTED TO THE RIGHT SIDE OF THE INSERTION HANDLE, NOT THE LEFT SIDE. THIS WAS IDENTIFIED AS A POTENTIAL PROBLEM ISSUE IF USED IN SURGERY FOR A LEFT ARM, AND THUS THESE 2 ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731818 ↗
• 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 19725859 ↗
• MalfunctionFeb 23, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT REPORTED THAT OR SAYS THIS ITEM BROKE DURING A CASE. WAS SURGERY DELAYED DUE TO THE REPORTED . THIS REPORT IS FOR ONE (1) INSRT HNDL FOR MULTILOC HUM NLING SYS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18770905 ↗
• MalfunctionFeb 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  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) INSRT HANDLE FOR MULTILOC HUM INGLING SYS THIS IS REPORT 4 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633311 ↗
• 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 AN INSERT-HANDLE F/MULTIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18292176 ↗
• 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 INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635870 ↗
• MalfunctionFeb 2, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE MULTILOC INSERTION HANDLE HAD BEEN DAMAGED PRIOR TO THE CASE, AND THE SURGICAL TEAM HAD GREAT DIFFICULTY WITH THE ALIGNMENT OF THE AIMING ARM ON THE INSERTION HANDLE. THERE WAS NO CONSEQUENCE TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ABOUT A 1-MINUTE DELAY. THIS REPORT INVOLVES ONE INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284825 ↗
• InjuryJan 25, 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 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)INSERT-HANDLE F/MULTILOC HUM NAIL SYST. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 16241785 ↗
• MalfunctionDec 23, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE INSERTION HANDLE FOR THE NAIL BEING USED IN THIS CASE WAS SLIGHTLY BENT AND NEEDED TO BE MANUALLY REALIGNED BY THE SURGEON DURING THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT OUTCOMES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16042440 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE MULTILOC INSERTION HANDLE WAS BROKEN. THIS WAS DISCOVERED BEFORE SURGERY, AND THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15787446 ↗
• MalfunctionSep 6, 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 SCREW THREAD WAS DAMAGED, AND THE NAIL DID NOT HOLD. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363131 ↗
• MalfunctionApr 15, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE INSERTION ARC OF THE MULTILOC HUMERAL NAILING (MHN) SYSTEM AT THE MOMENT OF INSERTING THE NAIL, BEGAN TO LOOSEN AND THE SURGEON NEEDED TO REARRANGE THE NAIL. DURING THE REMOVAL OF THE DEVICE TO REARRANGE THE NAIL, IT WAS OBSERVED THAT THE CONNECTION WITH THE INSERTION ARC WAS NOT GRIPPING WELL, AND THE TOP OF THE NAIL RAISED A FRAGMENT. THE SURGEON FIXED THAT PART AND INTRODUCED THE NAIL AGAIN; HOWEVER, IT CONTINUED TO FAIL AND INTERFERED WITH THE PROXIMAL LOCKING SINCE IT DID NOT MATCH. AN OPTION WAS GIVEN OF CHANGING THE NAIL FOR ANOTHER, BUT THE SURGEON PREFERRED TO CONTINUE. WHEN PERFORMING THE FREEHAND DISTAL LOCKING, THE SURGEON REQUESTED A 2.5 DRILL BIT WITH A SMALLER DIAMETER AND AT THE TIME OF IMPACTING, IT BENDED, AND THE 3.2 DRILL BIT WAS PASSED, WHICH WAS THE RECOMMENDED ONE, AND AT THE TIME OF IMPACTING IT AND AFTER DRILLING IT ALSO IT BENDED. THERE WAS A SURGICAL DELAY TO THE PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120580 ↗
• 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) INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847550 ↗

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