NA 03.037.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982070166), received between May 23, 2019 and Sep 30, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945849 ↗
• MalfunctionSep 14, 2026Break; Corroded; Material Twisted/Bent

  It was reported several instruments were found broken, stripped, and rusted. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753460 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE MULTI HOLE WIRE GUIDE WAS NOT ALLOWING THE PASSAGE OF A WIRE THRU THE MIDDLE WIRE HOLE. CLOSER LOOK SHOWED THE CENTER OF THE ITEM WAS IMPACTED. THIS DID NOT DELAY THE CASE OR CAUSE ANY ISSUES. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880655 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE SMALL METAL HEMISPHERICAL RETAINING FEATURE BELOW THE RIM OF COMPLAINED ITEM HAD COMPLETELY SHEARED OFF AND WAS NO LONGER PRESENT ON THE INSTRUMENT. STAFF DEEMED THE INSTRUMENT TO BE NO LONGER FUNCTIONAL, AND IT WAS SUBSEQUENTLY DISCARDED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141732 ↗
• MalfunctionMay 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING SURGERY THE DRILL SLEEVE AND THE PROTECTION SLEEVE WERE JAMMING INSIDE EACH OTHER. AFTER INSPECTING THE INSTRUMENTS, IT WAS UNCLEAR WHAT WAS CAUSING THE ISSUE. NO OTHER ISSUES WERE REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY WHILE ANOTHER SET WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950604 ↗
• MalfunctionDec 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023 TO TREAT PROXIMAL FEMUR FRACTURE, THE K-WIRE DID NOT FIT THROUGH THE CENTER HOLE OF NEW MULTI-HOLE DRILL GUIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. IT WAS FURTHER REPORTED THAT ADDITIONALLY ORDERED INSTRUMENT ALSO HAD THE SAME PROBLEM OF THE MATCHING K-WIRE DOES NOT FIT THROUGH THE MIDDLE HOLE OF THE INSTRUMENT. THIS REPORT IS FOR (B)(4) MULTI HOLE WIRE GUIDE. THIS IS REPORT 3 OF 3 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332144 ↗
• MalfunctionNov 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023 TO TREAT PROXIMAL FEMUR FRACTURE, THE K-WIRE DID NOT FIT THROUGH THE CENTER HOLE OF NEW MULTI-HOLE DRILL GUIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) MULTI HOLE WIRE GUIDE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193542 ↗
• MalfunctionFeb 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 03.037.000 WAS FOUND IN BACK UP LOOSE ITEM. IT HAS WIRE STUCK IN CANNULA. THERE WAS NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) MULTI HOLE WIRE GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16447393 ↗
• MalfunctionFeb 16, 2023Material Deformation; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, THE INSTRUMENT WAS UNABLE TO BE USED DURING SURGERY DUE TO DEFORMITY OF THE METAL. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) MULTI HOLE WIRE GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385253 ↗
• MalfunctionMay 31, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON UNKNOWN DATE WHILE TRYING TO DO TFNA AND THE CENTER HOLE OF THE MULTI HOLE DRILL SLEEVE IS DEFORMED SO A WIRE WILL NOT GO THROUGH IT. THERE IS NO PATIENT INVOLVEMENT. THIS FOUND BEFORE THE CASE. SO NO SURGERY DELAY DUE TO THIS EVENT. THIS REPORT IS FOR ONE (1) MULTI HOLE WIRE GUIDE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547413 ↗
• MalfunctionNov 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE HELICAL AIM ARM LOCK DEVICE WITH THE SILVER PUSH ATTACHMENT WAS CATCHING ON THE BONE AND WOULD NOT RELEASE. ALSO, THE T HANDLE BALL DRIVER COULD NOT BE TURNED WHEN UP AGAINST THE PATIENT, THE DRIVING CAP BROKE OFF, THE MULTI HOLE WIRE GUIDE WAS DIFFICULT TO REMOVE DURING SURGERY AND THE HELICAL/SCREW EXTRACTOR IS DIFFICULT TO CHANGE THE LENGTH OF THE GUIDE WIRE ONCE THE BLADE IS IN PLACE. THERE WAS A TWENTY (20) MINUTE SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MULTI HOLE WIRE GUIDE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745029 ↗
• MalfunctionSep 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRILL SLEEVE HANDLE WAS OVERTORQUED AND WAS BENT WHEN INSERTING THE EX FIX SLEEVES. WHILE INSERTING THE TWO STRAIGHT OUTRIGGERS ON THE COMBI CLAMP, IT ALSO WAS OVERTIGHTENED AND WAS STRIPPED. THE MULTI PIN GUIDE FOR THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS STICKING DURING THE CONTRALATERAL FEMUR WAS BEING IMPLANTED. THE HANDLE OF 395.911 WAS USE TO PULL TRACTION AND IT ENDED UP SCREWING UP THE THREADS OF THE HANDLE. A TRIPLE SLEEVE WAS THREADED IN AND WE WERE UNABLE TO THREAD IT IN. THE STRAIGHT OUTRIGGERS WERE BOTH UNABLE TO BE TIGHTENED. THERE WAS A THREE (3) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING DIFFERENT CLAMPS. CONCOMITANT DEVICE REPORTED: UNKOWN - EXFIX: (PART# UNKNOWN; LOT# UNKNOWN; QUALITY:1). THIS REPORT IS FOR ONE (1) MULTI HOLE WIRE GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488844 ↗
• MalfunctionJan 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION ON (B)(6) 2020, SEVERAL ISSUES WERE NOTED. THE MULTI HOLE WIRE GUIDE TIP HAS BEEN DAMAGED; GUIDE WIRES CANNOT GO THROUGH. THE RATCHETING SCREWDRIVER HANDLE IS CHIPPED. THE FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK IS MISSING THE INTERNAL PART THAT LOCKS IN SHAFT. AND THE HANDLE WITH QUICK COUPLING IS BROKEN AT THE TOP OF THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A MULTI HOLE WIRE GUIDE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154788 ↗
• MalfunctionMay 23, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE MULTIHOLE WIRE GUIDE WAS NOT PERMEABLE TO THE GUIDE WIRE DURING A PRACTICAL WORKSHOP WITH THE TFNA TEAM THAT WAS HELD IN THE OFFICE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MULTI HOLE WIRE GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8637367 ↗
• MalfunctionMay 23, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, IT WAS OBSERVED IN A PRACTICAL WORKSHOP WITH THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) TEAM THAT THE CENTRAL HOLE OF A MULTI DRILL SLEEVE WAS NOT PERMEABLE TO THE GUIDE WIRE. THIS PIECE OF INSTRUMENTS IS ESSENTIAL FOR ORIENTATION IN THE OPENING OF THE MEDULLARY CANAL AND IS USED BY SOME SPECIALISTS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MULTIHOLE WIRE GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636962 ↗