MULTILOC 04.019.044Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982089861), received between Oct 3, 2019 and Oct 3, 2019 — 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.

• MalfunctionOct 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, WHEN PLACING THE TITANIUM MULTILOC SCREW, IT MISSED THE TITANIUM MULTILOC HUMERAL NAIL AND IS NEXT TO IT INSIDE THE BONE. IT APPEARS THE NAIL ROTATED AFTER DRILLING THE SCREW HOLE THEREFORE DEFLECTING THE SCREW. THE SURGEON PLANS ON LEAVING IT AS IS. THIS ISSUE WAS DISCOVERED ON A POST-OPERATIVE X-RAY AFTER SURGERY WAS COMPLETED. PATIENT STATUS IS STABLE. THIS REPORT IS FOR ONE (1) 4.5 MM TI MULTILOC SCREW LENGTH 44 MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9150281 ↗

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