NA 04.005.426SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982085399), received between Jun 13, 2018 and Jun 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K000089, 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 18, 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.

• MalfunctionJun 13, 2018Bent; Bent

  IT WAS REPORTED THAT ON (B)(6) 2018 DURING AN INTRAMEDULLARY (IM) NAILING PROCEDURE OF THE RIGHT TIBIA FOR A FRACTURED TIBIA, IT WAS DISCOVERED THAT A LOCKING SCREW WAS BENT. THE SCREW WAS USED AND IMPLANTED IN THE PATIENT. THERE WAS NO SURGICAL DELAY. THERE WERE NO REPORTED SURGICAL AND PATIENT OUTCOMES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596674 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000089, 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