MULTILOC 04.019.000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982089533), received between Apr 1, 2022 and Apr 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE WITH THE MULTILOC AND END CAP FOR A FRACTURE OF THE PROXIMAL HUMERUS. WHEN THE SURGEON TRIED TO INSERT THE END CAP IN QUESTION, IT COULD NOT BE FULLY INSERTED DESPITE SEVERAL ATTEMPTS. THE SURGEON ATTEMPTED TO INSERT AND TIGHTEN THE END CAP MANUALLY AND COMPLETED THE SURGERY WITH THE END CAP PLACED AT AN ANGLE INTO THE NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A 30 MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI MULTILOC END CAP MULTILOC NL/0 EXT-S. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978928 ↗

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-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
• 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