MULTILOC 04.016.035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982089199), received between Jul 1, 2014 and Jun 23, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD A HARDWARE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 22308317 ↗
• MalfunctionMay 13, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON APRIL 18, 2022, WHILE DRILLING FOR THE DISTAL INTERLOCKING SCREW IN A MULTILOC HUMERAL NAIL, THE DRILL BIT ENCOUNTERED THE NAIL AND DID NOT PASS. THE SURGEON FREE HANDED THE DRILL AND WAS ABLE TO PLACE THE INTERLOCKING SCREW. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). AIM ARM/LAT/F/MULTILOC PROXIMAL HUM NL (PART# 03.019.008, LOT# UNKNOWN, QTY 1). THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR HUMERAL NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399556 ↗
• InjuryMar 31, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE GRAPHIC CASE FOR THE MULTILOC NAIL WAS BENT PRIOR TO OPENING BEFORE THE SURGERY. A SHORT MULTILOC NAIL WAS INSERTED DURING THE SURGERY. A FRACTURE WAS CREATED IN THE SHAFT OF THE NAIL DURING INSERTION,. THE NAIL WAS REMOVED, AND A NEW LONG NAIL WAS USED TO SPAN THE FRACTURE CREATED BY THE NAIL. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THERE WAS A PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICES 8 TI MULTILOC PROX HUM NL/LFT/CANN/160-S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966457 ↗
• InjuryFeb 15, 2019Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2019, THE AIMING ARM AND PROTECTION SLEEVE MISSED THE TWO (2) DISTAL NAIL HOLES IN MULTILOC NAIL. THIS WAS DISCOVERED AFTER THE TWO (2) TITANIUM LOCKING SCREWS WERE IMPLANTED. ON RADIOGRAPHIC REVIEW, THE TWO (2) TITANIUM LOCKING SCREWS WERE IN THE BONE BUT NOT IN THE NAIL. THE SURGEON REMOVED THE TWO (2) TITANIUM LOCKING SCREWS. TWO (2) NEW SCREWS WERE INSERTED INTO THE NAIL VIA FREEHAND TARGETING TECHNIQUE. IT WAS SUSPECTED THAT THE AIMING ARM CAME LOOSE DURING THE NAIL INSERTION WHICH CAUSE THE MAL-ALIGNMENT. THE SCREW HOLES TARGETED AS PLANNED ON THE BACK TABLE DURING A PRACTICE TEST. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE OUTCOME WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER. THIS REPORT IS 3 OF 5 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 8344404 ↗
• InjuryJul 1, 2014Device Operates Differently Than Expected; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED PROXIMAL HUMERUS FRACTURE. NAILING OF THE PROXIMAL HUMERUS WITH A SYNTHES MULTILOCHUMERAL NAIL TO PLACE ON AN UNKNOWN DATE IN EARLY (B)(6) 2014. THE NAIL CONSTRUCT APPEARS TO HAVE FAILED AND NEEDED TO BE REMOVED. A TOTAL REVISED SHOULDER IMPLANT WAS NOTES AND SHOULDER PROSTHESIS WAS PLACED. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Impaired Healing; Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 3906710 ↗

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