MULTILOC 04.019.050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982089922), received between May 17, 2019 and Jun 13, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, BEFORE THE CASE STARTED, THE SALES CONSULTANT WAS TEACHING THE SURGICAL TECHNOLOGIST ON HOW TO LOAD THE TITANIUM MULTILOC SCREWS ONTO THE UNKNOWN SCREWDRIVER. WHEN THIS SCREW WAS UNABLE TO BE LOADED, THE SURGICAL TECHNOLOGIST NOTED THAT THE SCREW SEEMED TO BE BENT OUT OF SHAPE. THIS SCREW WAS NOT NEEDED DURING THE ACTUAL CASE SO THERE WAS NO PATIENT INVOLVEMENT OR DELAY TO THE CASE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8696736 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD HARDWARE REMOVAL OF ONE (1) MULTILOC HUMERAL NAIL, ONE (1) MULTILOC SCREW LENGTH 50MM, ONE (1) MULTILOC SCREW LENGTH 42MM, ONE (1) MULTILOC SCREW LENGTH 48MM, ONE (1) MULTILOC SCREW LENGTH 40MM, ONE (1) TITANIUM LOCKING SCREW LENGTH 34MM, AND ONE (1) TITANIUM LOCKING SCREW LENGTH 36MM DUE TO SHOULDER PAIN AND LIMITED MOBILITY OF HUMERUS. THERE WERE FOUR PART PROXIMAL HUMERUS FRACTURE FIXED WITH THE NAIL BUT THE BONE HAD GONE ON TO DIE. THE SURGEON REMOVED ALL THE IMPLANTS BECAUSE THE HEAD JUST FELL INTO VARIOUS COLLAPSE AND TAKE THE DEAD BONY FRAGMENTS. INITIAL SURGERY WAS DONE ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5MM TI MULTILOC SCREW 50MM. THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis; No Code Available; Pain

  MAUDE report 8621218 ↗

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