NA 357.428Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982196460), received between Aug 28, 2017 and Dec 8, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THE INSERTER/EXTRACTOR WAS DISCOVERED BROKEN WHEN OPENED PRE-OPERATIVELY FOR A TFN REMOVAL CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23749542 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN TINE ON INSERTION END. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606575 ↗
• InjuryOct 14, 2022Entrapment of Device; Device-Device Incompatibility; Material Deformation; Entrapment of Device; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING TROCHANTERIC FIXATION NAIL (TFN) REMOVAL CASE, THE T HANDLE FOR REMOVAL OF THE LAG SCREW AND THE CONNECTING PIN WERE DAMAGED. THE TFN NAIL WAS UNABLE TO BE REMOVED DUE TO THIS DAMAGE LEADING PATIENT BEING CLOSED WITHOUT THE NAIL BEING REMOVED. THERE WAS DIFFICULTY GETTING THE ¿FLATS¿ OF THE T HANDLE TO ¿MATE¿ PROPERLY WITH THE END OF THE LAG SCREW. DUE TO THIS THE FLATS FOR THE T HANDLE BENT OUTWARDS AND THE THREAD OF THE CANNULATED CONNECTING PIN SNAPPED OFF IN THE LAG SCREW. THE IMPLANT WAS NOT ABLE TO BE REMOVED AS PLANNED. THIS REPORT IS FOR ONE (1) TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15611267 ↗
• MalfunctionFeb 4, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE TABS WERE BENT AT THE END OF HANDLE. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TFN SCR INSERTER/EXTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451469 ↗
• MalfunctionDec 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A NECK FOR FEMUR PROCEDURE PERFORMED ON AN UNKNOWN DATE, TWO (2) TFN SCREW INSERTER/EXTRACTOR AND ONE (1) CONNECTING SCREW SHORT WERE REMOVED FROM THE TRAYS BECAUSE THEY NO LONGER CONNECT PROPERLY TO THE IMPLANTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW TRAY. THERE WAS SURGICAL DELAY OF 5-10 MINUTES DUE TO THE REPORTED EVENT. PATIENT OUTCOME IS REPORTED AS FINE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077057 ↗
• MalfunctionDec 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A NECK FOR FEMUR PROCEDURE PERFORMED ON AN UNKNOWN DATE, TWO (2) TFN SCREW INSERTER/EXTRACTOR AND ONE (1) CONNECTING SCREW SHORT WERE REMOVED FROM THE TRAYS BECAUSE THEY NO LONGER CONNECT PROPERLY TO THE IMPLANTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW TRAY. THERE WAS SURGICAL DELAY OF 5-10 MINUTES DUE TO THE REPORTED EVENT. PATIENT OUTCOME IS REPORTED AS FINE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077056 ↗
• MalfunctionJun 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN SURGERY THAT THE TFN SCREW WAS DIFFICULT TO INSERT. UPON INSPECTION, POST-SURGERY, THE PRONGS ON THE END OF THE TFN SCREW INSERTER/EXTRACTOR WERE NOTED TO BE DAMAGED/WARPED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: TFN SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES 1 TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10157349 ↗
• InjurySep 12, 2019Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) REMOVAL PROCEDURE ON (B)(6) 2019, TWO EXTRACTION INSTRUMENTS BROKE. THE EXTRACTOR WAS CONNECTED TO THE NAIL TO REMOVE IT. IT CONNECTED BUT DIDN'T GRAB THE NAIL. IT WOULD ROTATE AND THEN SPLIT. A SECOND SET WAS OPENED, AND THE SAME THING HAPPENED. THE NAIL REMAINED IN PLACE IN THE PATIENT. THE SURGEON DECIDED TO LEAVE FRAGMENTS OF THE BROKEN DEVICES IN THE PATIENT¿S FEMORAL NECK. THERE WAS AN UNSPECIFIED SURGICAL DELAY. CONCOMITANT DEVICES: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN); TFN NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9007995 ↗
• MalfunctionAug 27, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THERE WAS AN ISSUE UPON INSERTING A LAG SCREW INTO THE HEAD OF FEMUR. THE LAG SCREW BECAME LOOSE FROM THE LAG SCREW INSERTER AND WAS NOT ABLE TO BE REATTACHED. PRONGS ON END OF LAG SCREW INSERTER APPEAR TO BE SLIGHTLY BENT OUTWARDS. THERE WAS A SURGICAL DELAY OF 5 TO 10 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO MEDICAL INTERVENTION WAS REQUIRED. CONCOMITANT DEVICE REPORTED: UNKNOWN LAG SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7820806 ↗
• MalfunctionJan 22, 2018Break; Break

  IT WAS REPORTED THAT UPON OPENING THE SET TO RESTOCK INSTRUMENTS, IT WAS DISCOVERED THAT ONE OF THE TINES AT THE END OF THE T-HANDLE WERE BROKEN OFF. THERE WAS NO CASE OR PATIENT INVOLVEMENT. THERE IS 1 DEVICE IN THIS COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7211180 ↗
• MalfunctionAug 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A LEFT TROCHANTERIC FIXATION NAIL (TFN) REMOVAL WAS PERFORMED ON (B)(6) 2017. A COMBINATION T-WRENCH 8MM BROKE DURING THE CASE. THE SURGEON WAS ATTEMPTING TO REMOVE THE LAG SCREW WHEN IT BROKE. THE SOCKET PORTION SPLIT IN HALF INTO TWO PIECES. ALL FRAGMENTS WERE RETRIEVED. NO REPORTED SURGICAL DELAY. AFTER THIS, A TFN SCREW INSERTER/EXTRACTOR WAS USED TO FURTHER ATTEMPT TO REMOVE THE LAG SCREW. THE HEX SOCKET ROUNDED OFF AND THE TABS INSIDE THE WRENCH FLARED. NO REPORTED SURGICAL DELAY, AND NO FRAGMENTS CREATED. EVENTUALLY THE SURGEON WAS ABLE TO EXPLANT THE LAG SCREW OUT WITH ANOTHER INSTRUMENT. ALSO DURING THE CASE, THE TIP OF THE EXTRACTION SCREW GUIDE BENT WHILE THE SURGEON ATTEMPTED TO REMOVE THE NAIL. ANOTHER EXTRACTION PIECE WAS USED TO REMOVE THE NAIL SUCCESSFULLY. NO REPORTED SURGICAL DELAY, NO FRAGMENTS CREATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT IS FOR ONE DEVICES. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6825407 ↗