MULTILOC 04.019.034SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982089779), received between Oct 21, 2022 and Jan 14, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR HUMERAL DIAPHYSEAL FRACTURE WITH THE PRODUCTS IN QUESTION. AFTER THE SURGERY, THE SWELLING WAS OBSERVED DUE TO HEMATOMA ACCUMULATION AT THE DISTAL TRANSVERSE STOP SCREW HEAD. A REMOVAL SURGERY WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IT WAS OBSERVED THAT THE PULLED NAIL BODY AND THE SIDE STOPPER SCREW WERE COLORED IN A SPECKLED STATE. THE SURGEON OPINES THAT IT WAS CAUSED BY THE INFECTION.

  Patient problems: Hematoma; Swelling/ Edema; Unspecified Infection

  MAUDE report 21147543 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY FOR FRACTURE FIXATION OF THE LONG BONES. THE PATIENT EXPERIENCED A PERI-IMPLANT FRACTURE DISTAL TO THE HUMERAL NAIL REQUIRING SURGICAL INTERVENTION. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE 4.5MM TI MULTILOC SCREW LENGTH 34MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 15650048 ↗

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