MULTILOC 04.019.042SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982089854), received between Jul 9, 2025 and Sep 17, 2025 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT UNKNOWN SURGERY FOR A FRACTURE OF THE DISTAL END OF THE TIBIA. WHEN THE SURGEON RETRIEVED THE PRODUCT IN QUESTION FROM THE IMPLANT SET AND OPENED THE STERILE TUBE, THE SURGEON FOUND THAT THERE WAS NO SCREW INSIDE THE STERILE TUBE. THE SURGEON USED A PRODUCT OF THE SAME SIZE BUT A DIFFERENT LOT NUMBER FOR THE SURGERY. THE SURGEON/HOSPITAL HAS REQUESTED AN INVESTIGATION REGARDING THE CONTENT OF THE STERILE TUBE BEING FOUND EMPTY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080033 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF SURGERY FOR PROXIMAL HUMERUS FRACTURE WITH THE SCREWS IN QUESTION. IN THE SURGERY, A CRACKING SOUND WAS HEARD WHILE INSERTING THE SCREW-IN SCREW. AFTER THAT, THE DISTAL SCREW WAS ALSO INSERTED, AND WHEN CHECKING THE ENTIRE STRUCTURE USING THE IMAGE, THE PRODUCT WAS FOUND TO HAVE BROKEN, SO IT WAS REMOVED WITH RADIO PLIERS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IN THE DOCTOR'S OPINION, THE PATIENT WAS IN HIS 80S AND DID NOT HAVE GOOD BONE QUALITY, SO HE DID NOT INTEND TO HAVE USED THAT MUCH FORCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459092 ↗

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