NA 04.005.416Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982085283), received between Sep 16, 2019 and Nov 10, 2020 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K000089, 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 18, 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.

• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE AND REMOVAL OF THE MULTI LOCK FEMORAL NAIL. THE IMPLANT REMOVAL WAS DUE TO THE QUALITY OF IMPLANTS AND NON-UNION. INITIALLY, PATIENT HAD A ZIMMER BIOMET PROXIMAL HUMERUS PLATE THAT WAS REVISED TO SYNTHES MULTILOC HUMERAL NAIL DUE TO ZIMMER PLATE FAILURE. IT WAS ALSO MENTIONED THAT THE PATIENT HAD AN INFECTION PRIOR TO SURGICAL IMPLANT THAT ULTIMATELY LED TO THE NON-UNION. DURING THE PROCEDURE, THE FEMORAL IMPLANT WAS REMOVED AHEAD PROXIMAL NAIL TO GET THE PROXIMAL SCREW STILL INTACT. THE PATIENT WAS THEN REVISED TO A REVERSE SHOULDER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM FOR IM NAILS. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10816851 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, IT WAS FOUND OUT THAT AN UNKNOWN HUMERAL NAIL SET DO NOT HAVE AN UNKNOWN CADDY WITH AN UNKNOWN BLADES, UNKNOWN 4.0 TITANIUM SCREWS AND UNKNOWN END CAPS. ORIGINALLY, THE SALES CONSULTANT GETS THE SET AND THERE¿S GOING TO BE A TOTE WITH IMPLANTS FOR BLADES AND SCREWS AND END CAPS. THE SALES CONSULTANT CALLED THE FSL AND EVENTUALLY DISCOVERED THAT THERE WAS SUPPOSED TO BE A CADDY INSIDE THE SET. THE SALES CONSULTANT THEN GO AND DRIVE TO ANOTHER HOSPITAL AND RETURN WITH A TOTE FOR SAID IMPLANTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED; HOWEVER, THE PATIENT SPENT AN EXTRA 100 MINUTES UNDER ANESTHESIA. ALSO, THE END CAP AVAILABLE FROM THE OTHER HOSPITAL WAS NOT THE CORRECT SIZE, SO IT PROTRUDED FROM THE PATIENT¿S HUMERAL HEAD. RE-OPERATION IS MOST LIKELY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-EIGHT (38) DEVICES. (B)(4).

  Patient problems: No Code Available

  MAUDE report 9072682 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000089, 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