MULTILOC 03.019.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982069467), received between Dec 31, 2018 and Jul 12, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING INSPECTION OF SOME MULTILOC HUMERAL NAIL INSTRUMENTS, IT WAS DETERMINED THAT THE INSERT-HANDLE F/MULTILOC HUM NAIL SYSTAND AND THE AIM-ARM ANT F/MULTILOC HUM NAIL SYST, WHICH ARE TWO COMPONENTS THAT ARE DESIGNED TO CONNECT SECURELY TO EACH OTHER WHEN IN USE, WOULD ONLY CONNECT CORRECTLY WHEN THE AIM-ARM ANT F/MULTILOC HUM NAIL SYSTWAS CONNECTED TO THE RIGHT SIDE OF THE INSERT-HANDLE F/MULTILOC HUM NAIL SYST, 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 AIMING ARM/ANT/F/MULTILOC PROXIMAL HUMERAL NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731816 ↗
• 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/ANT/F/MULTILOC PROXIMAL HUM NL THIS IS REPORT 3 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632836 ↗
• MalfunctionAug 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) 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/ANT/F/MULTILOC PROXIMAL HUMERAL NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258081 ↗
• MalfunctionDec 31, 2018Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, AN OPEN REDUCTION INTERNAL FIXATION WITH MULTILOC HUMERAL NAIL WAS APPLIED TO SURGERY FOR THE PROXIMAL HUMERAL FRACTURE. THE DEVICES WERE CHECKED AFTER THE SURGERY AND IT WAS FOUND OUT THAT THERE WAS A SMALL BLACK PART, IT WAS CONFIRMED TO BE A PART OF THE AIMING ARM. IT WAS REPORTED THAT THE ACTUAL PROBLEM WAS NOT THE DEVICE WAS BROKEN, BUT THE PIN CAME OFF THE DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY, THE SURGEON COMPLAINED SAYING THAT, IF THE PART HAD COME OFF DURING INSERTING OF THE NAIL AND IT HAD REMAINED IN THE PATIENT, THE OPERATION WOULD HAVE BEEN DELAYED. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN MULTILOC HUMERAL NAIL (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8206290 ↗

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