NA 04.005.418Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982085306), received between Dec 4, 2018 and May 9, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure to Align” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A HUMERAL NAIL WAS REMOVED DUE TO VARUS COLLAPSE CAUSING NAIL PROMINENCE PROXIMALLY LEADING TO PATIENT DISCOMFORT. FRACTURE HAD HEALED. IMPLANT AND EXPLANT DATES ARE UNKNOWN. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR A LOCKING SCREW.

  Patient problems: Bone Fracture(s); Discomfort

  MAUDE report 14338609 ↗
• 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. THIS IS REPORT 6 FOR 10 (B)(4). OTHER DEVICES WAS INCLUDED WITH RELATED INCIDENTS: (B)(4).

  Patient problems: No Code Available

  MAUDE report 9072673 ↗
• 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) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS. THIS REPORT IS 4 OF 5 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 8344434 ↗
• 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) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS. THIS REPORT IS 5 OF 5 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 8344433 ↗
• InjuryDec 4, 2018Migration; Migration

  IT WAS REPORTED ON (B)(6) 2018, THE PATIENT UNDERWENT A REMOVAL/REVISION OF DAMAGED TITANIUM LOCKING SCREWS IN THE TIBIA NAIL ON AN UNKNOWN DATE. IT WAS FURTHER REPORTED, THE TITANIUM LOCKING SCREW MAY HAVE MIGRATED AND WAS REMOVED AND REPLACED WITH A LONGER SCREW. THE UNKNOWN LOCKING SCREW WAS BROKEN AND A PIECE WAS RETAINED, ANOTHER SCREW WAS PLACED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN TIBIAL NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8130308 ↗

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