NA 03.010.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 10886982066916), received between Mar 24, 2017 and Sep 24, 2026 — classified as 13 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (32 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 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Twisted/Bent

  It was reported that the nail extraction screw from the ANS removal instruments is cross threaded. We are unable to screw it all the way into the head element. And sometimes jumps out while backslapping. There was a surgical delay of twenty (20) minutes. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884612 ↗
• MalfunctionSep 22, 2026Material Integrity Problem

  It was reported that the threads of the Extraction Screw were damaged.

  Patient problems: Insufficient Information

  MAUDE report 50858093 ↗
• MalfunctionSep 15, 2026Material Twisted/Bent

  It was reported that there was difficulty removing a nail due to damaged items in our loan set. The extraction instrument had a damaged thread so the hammer guide could not be attached to it. Not sure exactly how, but the surgeon was successful in removing the nail after delay. The nail was removed, not revised.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773852 ↗
• MalfunctionSep 9, 2026Material Twisted/Bent

  It was reported on an unknown date that (ExtractScr f/Tib+Fem Nails) was received at the analysis site. The device was stripped and worn.(b)(4) are related to each other.(b)(4) is created to add and capture (ExtractScr f/Tib+Fem Nails) of (b)(4) as an additional impacted product.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690633 ↗
• MalfunctionAug 27, 2026Device-Device Incompatibility

  It was reported extraction screw and sliding guide are attached since it is not possible to release the devices.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474358 ↗
• MalfunctionMay 19, 2026Device-Device Incompatibility; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT CONNECSCR CANN LONG AND EXTRACTSCR F/TIB+FEM NAILS WERE ASSOCIATED WITH POST-OPERATIVE DEVICE ISSUES. TWO CONNECTING SCREWS BECAME UNUSABLE AS THEY DID NOT ATTACH PROPERLY TO THE T HANDLE SCREWDRIVER, AND ONE EXTRACTION SCREW WOULD NOT HOLD INTO THE NAIL BEING REMOVED DUE TO AN ISSUE WITH THE THREADS. THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT, AND NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217261 ↗
• MalfunctionFeb 2, 2026Material Twisted/Bent

  THESE HAVE BECOME WORN OUT AND NO LONGER ATTACH TO THE IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233812 ↗
• MalfunctionJan 27, 2026Material Deformation; Material Twisted/Bent

  DEVICE WAS DAMAGED DURING REMOVAL PROCESS, LIKELY DUE TO EXCESSIVE FORCE DURING REMOVAL. THE PRODUCT DAMAGE DOCUMENTED WAS IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189142 ↗
• MalfunctionMay 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025 THE SURGEON WAS DOING A TIBIAL NAIL EXCHANGE. THE SURGEON COULDN'T GET THE OLD NAIL OUT AND CROSS THREADED THE EXTRACTION SCREW SO THE SCREW DID NOT CONNECT TO THE OLD NAIL. THE SURGEON OPENED UP THE OTHER THREE SETS, HOWEVER HAD THE SAME THING HAPPENED AGAIN. THE SURGEON HAD TO USE THE EXTRACTION HOOK GUIDE ROD TO REMOVE NAIL. WHEN PLACING THE NEW NAIL, IT WAS NOTICED THAT THE AIMING ARM DID NOT SIT CORRECTLY. IT WAS BROKEN WITH A PIECE OF THE PART THAT CONNECTS TO THE HOOK WAS BROKEN OFF. THE PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22004886 ↗
• MalfunctionMay 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025 THE SURGEON WAS DOING A TIBIAL NAIL EXCHANGE. THE SURGEON COULDN'T GET THE OLD NAIL OUT AND CROSS THREADED THE EXTRACTION SCREW SO THE SCREW DID NOT CONNECT TO THE OLD NAIL. THE SURGEON OPENED UP THE OTHER THREE SETS, HOWEVER HAD THE SAME THING HAPPENED AGAIN. THE SURGEON HAD TO USE THE EXTRACTION HOOK GUIDE ROD TO REMOVE NAIL. WHEN PLACING THE NEW NAIL, IT WAS NOTICED THAT THE AIMING ARM DID NOT SIT CORRECTLY. IT WAS BROKEN WITH A PIECE OF THE PART THAT CONNECTS TO THE HOOK WAS BROKEN OFF. THE PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22004885 ↗
• MalfunctionMay 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025 THE SURGEON WAS DOING A TIBIAL NAIL EXCHANGE. THE SURGEON COULDN'T GET THE OLD NAIL OUT AND CROSS THREADED THE EXTRACTION SCREW SO THE SCREW DID NOT CONNECT TO THE OLD NAIL. THE SURGEON OPENED UP THE OTHER THREE SETS, HOWEVER HAD THE SAME THING HAPPENED AGAIN. THE SURGEON HAD TO USE THE EXTRACTION HOOK GUIDE ROD TO REMOVE NAIL. WHEN PLACING THE NEW NAIL, IT WAS NOTICED THAT THE AIMING ARM DID NOT SIT CORRECTLY. IT WAS BROKEN WITH A PIECE OF THE PART THAT CONNECTS TO THE HOOK WAS BROKEN OFF. THE PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22004882 ↗
• MalfunctionMay 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025 THE SURGEON WAS DOING A TIBIAL NAIL EXCHANGE. THE SURGEON COULDN'T GET THE OLD NAIL OUT AND CROSS THREADED THE EXTRACTION SCREW SO THE SCREW DID NOT CONNECT TO THE OLD NAIL. THE SURGEON OPENED UP THE OTHER THREE SETS, HOWEVER HAD THE SAME THING HAPPENED AGAIN. THE SURGEON HAD TO USE THE EXTRACTION HOOK GUIDE ROD TO REMOVE NAIL. WHEN PLACING THE NEW NAIL, IT WAS NOTICED THAT THE AIMING ARM DID NOT SIT CORRECTLY. IT WAS BROKEN WITH A PIECE OF THE PART THAT CONNECTS TO THE HOOK WAS BROKEN OFF. THE PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22004867 ↗
• MalfunctionMar 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT STAGE 1 OF 2 FOR THA ON (B)(6) 2025. THE FEMORAL NAIL WAS BENT AND ROTATED, MAKING IT EXTREMELY DIFFICULT TO EXTRACT. AS A RESULT, THE EXTRACTION SCREW WAS DAMAGED (BENT). PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707348 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A TIBIAL NAILING CASE, THE INSTRUMENTS BROKE WHEN REMOVING THE NAIL FROM THE PATIENT AND WERE UNABLE TO BE USED. STAFF OPENED UP A SECOND TIBIAL NAIL TRAY AND WERE ABLE TO COMPLETE THE CASE IN A TIMELY MANNER WITH NO CONSEQUENCES. THERE WAS A SURGICAL DELAY OF 3 MINUTES. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272918 ↗
• MalfunctionJan 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT BOTH INSTRUMENTS HAVE WORN THREADS. THE PRODUCT DAMAGE HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113067 ↗
• MalfunctionOct 16, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREAD OF THREE EXTRACTION SCREWS ARE DAMAGED. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467482 ↗
• MalfunctionOct 16, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREAD OF THREE EXTRACTION SCREWS ARE DAMAGED. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467216 ↗
• MalfunctionOct 16, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT OCCURRED IN POST-OP. THERE WAS A PATIENT INVOLVEMENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS WAS GOOD.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465883 ↗
• MalfunctionSep 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT IN 2024, DURING THE LOAN KIT INSPECTION IT WAS NOTICED THAT THE THREADING WAS DAMAGED ON ALL THREE ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20282565 ↗
• MalfunctionJun 26, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED DURING A SURGERY ON (B)(6) 2024, AT THE TIME OF THE EXTRACTION OF THE NAIL, IT WAS EVIDENCED THAT THE THREAD OF THE EXTRACTION SCREW WAS DAMAGED AND DIDN'T FIT IN THE NAILS. THE NAIL EXTRACTED FROM THE PATIENT WAS FROM DEPUY SYNTHES BUT THE PATIENT HAD A PSEUDOARTHROSIS, WHICH IS WHY IT WAS NECESSARY TO CHANGE IT TO AN ANTIBIOTIC-RELEASING NAIL. IT WAS NECESSARY TO EXTEND THE SURGICAL TIME OF THE SURGERY ABOUT 40 MINUTES MORE THAN NORMAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A UNIVERSAL RETIREMENT EQUIPMENT THAT WAS IN THE INSTITUTION. THE PATIENT WAS STABLE AND DID NOT PRESENT SECONDARY OR MAJOR COMPLICATIONS. THIS REPORT IS FOR ONE CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT (B)(4) CAPTURES THE INTRAOPERATIVE EVENT, WHILE (B)(4) CAPTURES THE NEED FOR REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614467 ↗
• MalfunctionJun 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A REMOVAL SURGERY. THE SURGEON ATTACHED THE EXTRACTION SCREW TO THE NAIL AFTER REMOVING THE END CAP, BUT IT DID NOT ENGAGE WITH THE NAIL PROPERLY. THEREFORE, THE SURGEON THOUGHT TO TIGHTEN THE EXTRACTION SCREW WITH A WRENCH, BUT THERE WAS NO WRENCH BECAUSE IT WAS NOT A COMPONENT OF THE INSTRUMENT SET PROVIDED FOR THE SURGERY. NEXT, THE SURGEON THOUGHT TO USE A RESCUE SCREW FOR NAIL EXTRACTION, WHICH IS SET-SCREW SHAPED SCREW, BUT THERE WAS NO RESCUE SCREW BECAUSE ONE HAD NOT BEEN HAD NOT PREPARED. EVENTUALLY, THE SURGEON EXTRACTED THE NAIL WITH A COMPETITOR¿S INSTRUMENT. THE SURGERY WAS COMPLETED USING AN ALTERNATIVE PRODUCT WITH NO SURGICAL DELAY. EXTRACTION SURGERY WAS PERFORMED AS BONE FUSION WAS ACHIEVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) CONICAL 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 19570477 ↗
• MalfunctionMay 1, 2024Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DRIVING CAP F/INSERTION HANDLE AND THE INSERT HANDLE RADIOLUC FEM RECON NAIL WERE UNABLE TO BE DISASSEMBLED AFTER SURGERY. IT WAS LATER REPORTED THAT AFTER VIEWING THE ITEMS, IT WAS NOTED THAT THE CUSTOMER HAD ASSEMBLED THE WRONG ITEMS. INSTEAD OF THE DRIVING CAP F/INSERTION HANDLE, THEY HAD USED AN EXTRACTSCR F/TIB+FEM NAILS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226019 ↗
• MalfunctionApr 16, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE LOAN TIBIAL NAIL REMOVAL SET WAS USED TO REMOVE AN EXPERT TIBIAL NAIL. THE REMOVAL WAS PERFORMED TO INVESTIGATE THE REASON FOR THE PATIENT¿S KNEE PROBLEMS. DURING THE SURGERY, THE THREAD OF THE EXTRACTION TOOL WAS DAMAGED AND THE SURGEON COULD NOT ENGAGE IT INTO THE NAIL. AFTER 45 MINUTES OF TRYING, THE SURGEON SWITCHED TO THE CONICAL EXTRACTION TOOL AND DISCOVERED THE STOP FOR THE END OF THE GUIDE FOR THE SLAP HAMMER DID NOT FIT. THE SURGERY WAS DELAYED BY 60 MINUTES DUE TO THE EVENT AND WAS SUCCESSFULLY COMPLETED. THE SURGEONS WERE EVENTUALLY ABLE TO REMOVE THE NAIL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19118845 ↗
• MalfunctionMar 4, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A REMOVAL OF THE TNA (TIBIAL NAIL ADVANCED) NAIL IMPLANTS. A SCREW THREAD FOR REMOVAL-USE SCREW WAS CRUSHED, AND CONNECTING THE NAIL WAS DIFFICULT. A HEXAGONAL WRENCH WAS PLANNED TO BE USED, BUT IT WAS NOTICED THAT BOTH OF THE INSTRUMENT SETS CONCERNED ORIGINALLY DID NOT INCLUDE THE HEXAGONAL WRENCH, SO THIS WAS NOT POSSIBLE. FINALLY, ALL THE NAILS OF INSERTED IMPLANTS WERE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THE REASON FOR THE REMOVAL OF IMPLANTS IS UNKNOWN. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4) .

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825487 ↗
• MalfunctionMar 4, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A REMOVAL OF THE TNA (TIBIAL NAIL ADVANCED) NAIL IMPLANTS. A SCREW THREAD FOR REMOVAL-USE SCREW WAS CRUSHED, AND CONNECTING THE NAIL WAS DIFFICULT. A HEXAGONAL WRENCH WAS PLANNED TO BE USED, BUT IT WAS NOTICED THAT BOTH OF THE INSTRUMENT SETS CONCERNED ORIGINALLY DID NOT INCLUDE THE HEXAGONAL WRENCH, SO THIS WAS NOT POSSIBLE. FINALLY, ALL THE NAILS OF INSERTED IMPLANTS WERE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THE REASON FOR THE REMOVAL OF IMPLANTS IS UNKNOWN. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825485 ↗