NA 357.133Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10886982195883), received between Dec 30, 2016 and Mar 4, 2026 — classified as 3 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (29 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS OF EXTRACTION TOOL STRIPPED. CANNOT THREAD INTO NAIL PROPERLY FOR EXTRACTION. THERE WAS NO PATIENT HARM AND SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514289 ↗
• MalfunctionFeb 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS OF SCREW-IN PORTION FOR NAIL EXTRACTION INSTRUMENT ARE STRIPPED. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259046 ↗
• MalfunctionJan 15, 2026Material Integrity Problem; Material Twisted/Bent

  DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE THREADS ON TWO EXTRACTION SCREWS FOR TIBIAL NAILS WERE STRIPPED AND DAMAGED. THESE TWO ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080243 ↗
• MalfunctionJan 15, 2026Material Integrity Problem; Material Twisted/Bent

  DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE THREADS ON TWO EXTRACTION SCREWS FOR TIBIAL NAILS WERE STRIPPED AND DAMAGED. THESE TWO ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080210 ↗
• MalfunctionJan 7, 2026Material Deformation

  IT WAS REPORTED THAT THE EXTRACTION SCREW BENT DURING AN LFN NAIL EXTRACTION THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991722 ↗
• MalfunctionSep 17, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREAD WAS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT AND NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) EXTRACTION SCR FOR TI FEM & TIB NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238106 ↗
• MalfunctionSep 9, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON UNKNOWN DATE WHILE ORGANIZING, SETS AND INSTRUMENTS WE NOTICED SOME BROKEN AND DAMAGED PIECES NOT USEABLE FOR CASES. IT WAS OCCURRED DURING METRO CLEANUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169965 ↗
• MalfunctionMay 30, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2024, THE EXTRACTION SCREW AND SLAPVHAMMER GUIDE WERE CROSSED THREADED. AFTER IMPACTION, THEY COULD NOT BE DISASSEMBLED. THE SURGERY WAS DELAYED 14 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXTRACTION SCR FOR TI FEM & TIB NAIL THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19432003 ↗
• MalfunctionDec 12, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE THREADS OF THE INSTRUMENT IN QUESTION WARPED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 1 OF 1 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312451 ↗
• MalfunctionDec 8, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A NAIL REMOVAL CASE ON 17-NOVEMBER-2023, THE NAIL EXTRACTION BOLT IN QUESTION GOT DAMAGED. WHEN THE SCREW WAS REMOVED FROM THE NAIL IT WAS DISCOVERED THAT THE THREADS WERE DAMAGED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES, THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18292523 ↗
• MalfunctionOct 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT SURGEON REMOVED A TIBIAL NAIL ON (B)(6) 2023 BECAUSE OF A POSSIBLE INFECTION. THE NAIL WAS DIFFICULT TO REMOVE FOR VARIOUS REASON. SURGEON WAS UNABLE TO CONNECT THE APPROPRIATE EXTRACTOR FOR THE EX LOCKING NAILS AND THEREFORE HAD TO TRY MULTIPLE OPTIONS AND EVENTUALLY A COMPETITOR'S CONICAL EXTRACTOR SUCCESSFULLY EXTRACTED THE NAIL. THERE WERE ALREADY PREVIOUS UNKNOWN FRAGMENTS AS WELL FROM WHEN THE SURGEON WAS ATTEMPTING TO REMOVE A DIFFICULT INTERLOCKING SCREW. THE MOST DISTAL SCREW WAS BURIED IN BONE AND EVENTUALLY WAS KNOCKED OUT SUCCESSFULLY. ADDITIONALLY, ONE OF THE WRAPPERS OF A 3.0 REAMING ROD SPLIT. SALES REP OFFERED TO GRAB A NEW REAMING ROD, HOWEVER THE SURGICAL TECH AND NURSE DECIDED TO USE THAT ONE. SALES REP DID NOT CONFIRM IF FRAGMENTS WERE REMOVED FROM THE TIBIA AFTER THE REMOVAL. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FORTY FIVE (45) MINUTES. AFTER THE SURGERY, IT WAS NOTICED IN STERILE PROCESSING DEPARTMENT (SPD) THAT THE EXTRACTION SCREW THREADS HAVE BEEN DAMAGED. THIS REPORT CAPTURES THE POSTOP EVENT OF INFECTION, WHILE THE INTRA OP EVENT OF EXTRACTION SCREW THREAD DAMAGE AND ONE OF THE WRAPPERS OF A 3.0 REAMING ROD BREAKAGE ARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002709 ↗
• MalfunctionOct 17, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING INSPECTION ON (B)(6) 2023. A MDR STAFF INDICATED THAT THE THREADS ON THE EXPERT TIBIAL NAIL EXTRACTION SCREW WERE STRIPPED. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953717 ↗
• MalfunctionSep 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A SURGEON REMOVED A TIBIAL NAIL ON (B)(6) 2023 BECAUSE OF A POSSIBLE INFECTION. THE NAIL WAS DIFFICULT TO REMOVE FOR VARIOUS REASONS. THE SURGEON WAS UNABLE TO CONNECT THE APPROPRIATE EXTRACTOR FOR THE EX LOCKING NAILS, AND THEREFORE HAD TO TRY MULTIPLE OPTIONS SUCH AS THE NON-SYNTHES SET, JAMMING TWO REAMING RODS, A NON-SYNTHES EXTRACTION HOOK, AND A NON-SYNTHES CONICAL EXTRACTOR, WHICH SUCCESSFULLY EXTRACTED THE NAIL. THE NON-SYNTHES EXTRACTION HOOK TIP BROKE OFF DISTALLY TO THE NAIL. THERE WERE ALREADY PREVIOUS UNKNOWN FRAGMENTS AS WELL FROM WHEN THE SURGEON WAS ATTEMPTING TO REMOVE A DIFFICULT INTERLOCKING SCREW. THE MOST DISTAL SCREW WAS BURIED IN BONE AND EVENTUALLY WAS KNOCKED OUT SUCCESSFULLY. ADDITIONALLY, ONE OF THE WRAPPERS OF A 3.0 REAMING ROD SPLIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 45 MINUTES. IT IS NOT KNOWN WHETHER THE FRAGMENTS WERE REMOVED FROM THE TIBIA. AFTER THE SURGERY, IT WAS NOTED IN THE STERILE PROCESSING DEPARTMENT THAT THE EXTRACTION SCREW THREADS HAVE BEEN DAMAGED. THIS REPORT INVOLVES ONE EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE POSSIBLE INFECTION. THI

  Patient problems: Insufficient Information

  MAUDE report 17848294 ↗
• MalfunctionMar 27, 2023Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE INSTRUMENTS ARE UNABLE TO USE, STERILIZE AND OR ASSEMBLE. CHIPPING AND CRACKING WAS. UNABLE. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. IT WAS UNKNOWN WHEN WAS THE EVENT OCCURRED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) EXTRACTION SCR FOR TI FEM & TIB NAIL THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622526 ↗
• MalfunctionMar 13, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE RESETTING INSTRUMENTS, A NAIL EXTRACTOR¿S THREADS WERE FLATTENED OUT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) EXTRACTION SCR FOR TI FEM & TIB NAIL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529091 ↗
• MalfunctionFeb 16, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO EXTRACTION DEVICES WERE STRIPPED DURING THE REMOVAL OF THE NAIL. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16389668 ↗
• MalfunctionJan 17, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION, WHILE RESTOCKING THE INSTRUMENT TRAY, THE CONSULTANT NOTICED THAT THE THREADS ON THE EXTRACTION BOLT ARE WARPED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) EXTRACTION SCR FOR TI FEM & TIB NAIL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183358 ↗
• MalfunctionJan 17, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION, WHILE RESTOCKING THE INSTRUMENT TRAY, THE CONSULTANT NOTICED THAT THE THREADS ON THE EXTRACTION BOLT ARE WARPED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) EXTRACTION SCR FOR TI FEM & TIB NAIL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183351 ↗
• MalfunctionNov 28, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, SURGERY FOR A NON UNION OF A FEMORAL SHAFT FRACTURE WAS PERFORMED. A RAFN NAIL AND 2 INTERLOCKING SCREWS WERE EXTRACTED, AND A PLATE WAS PLACED. ADDITIONALLY, THE THREADS ON THE THREADED EXTRACTOR WERE DAMAGED DURING EXTRACTION. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS NONUNION AND DEVICE EXPLANTATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870417 ↗
• MalfunctionSep 19, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE THREADS ON THE EXTRACTION SCREW FOR EXPERT TIBIAL NAIL WERE STRIPPED. THERE WAS NO SURGICAL DELAY, AND NO CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451029 ↗
• MalfunctionJul 20, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 SURGEON WAS FIXING A FEMORAL SHAFT FRACTURE USING THE FEMORAL RECON NAIL. AFTER OVER REAMING BY 1.5MM AND REAMING THE PROXIMAL SEGMENT WELL BELOW THE LESSER TROCH HE INSERTED THE NAIL. AFTER STRIKING THE DRIVING CAP APPROXIMATELY 4 TIMES THE DRIVING CAP BROKE OFF IN THE INSERTION HANDLE AND FELL ON THE GROUND. THE SURGEON USED THE EXTRACTION PIECE TO CONTINUE TO DRIVE THE NAIL TO THE APPROPRIATE DEPTH. HE WAS ABLE TO FINISH THE SURGERY WITHOUT ANY FURTHER ISSUES. NO PATIENT CONSEQUENCE WAS THERE ALSO PROCEDURE SUCCESSFULLY COMPLETED. THIS REPORT IS FOR AN EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065777 ↗
• MalfunctionJun 28, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREADS ARE LOOSE/STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE EXTRACTION SCR FOR TI FEM & TIB NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840590 ↗
• MalfunctionJun 23, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A EXTRACTION SCREW WAS FOUND IN STERILE PROCESSING FUSED TO A NAIL. PROCEDURE AND PATIENT CONSEQUENCE WAS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787044 ↗
• MalfunctionMay 13, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED IN A SET IN SPD THE THREADS WERE STRIPPED ON EXTRACTION BOLT. IT WAS UNKNOWN WHETHER THERE WAS ANY PATIENT CONSEQUENCES REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE EXTRACTION SCR FOR TI FEM & TIB NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14394297 ↗
• MalfunctionApr 4, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF THE BACK UP DEVICES IT WAS DISCOVERED THAT THE GOLD PEG OF ONE (1) RECON LOCKING AIMING ARM FOR LFN NAILS-EX HAS SNAPPED OFF, THE THREADS OF ONE (1) EXTRACTION SCREW FOR TI FEMORAL & TIBIAL NAILS AND ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR ARE STRIPPED, AND ONE (1) DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS WAS STUCK IN PLACE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14001758 ↗