MULTILOC 04.019.022SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982089656), received between Sep 20, 2021 and Sep 20, 2021 — classified as 1 injury.

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.

• InjurySep 20, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A SURGICAL PROCEDURE, WHILE INSERTING AN INTERLOCKING MULTLILOC SCREW, THE SCREW WAS TOO SHORT. THE SURGEON CONTINUED TO TRY TO INSERT THE MULTILOC SCREW POSSIBLE STRIPPING OUT THE PLASTIC INSERT OF THE MULTILOC HUMERAL NAIL. THE SCREW WAS PULLED OUT OF THE BONE AND NAIL, AND ABANDONED THAT SCREW HOLE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE(5) MINUTES SURGICAL DELAY. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - INSERTION INSTRUMENTS: TRAUMA (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 4.5 TI MULTILOC SCREW LENGTH 22-STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495709 ↗

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