NA 03.010.170Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10886982068026), received between Nov 9, 2018 and May 7, 2026 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (25 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE T-HANDLE AND LOCKING MECHANISM AND INTERFACE TO THE FINGER REDUCTION TOOL KEEPS SLIDING OFF. THIS WAS WHILE PERFORMING THE FUNCTION BEFORE ASSEMBLING THE SET BEFORE PROCESSING. THE BACK SLAP POLE THAT HELPS REMOVE THE NAIL (THREADS ARE WORN); IT WILL NOT SCREW INTO THE BACK OF THE EXTRACTION BOLT FULLY. IT WAS NOTICED DURING ROUTINE INSPECTION. THE LID TO THE SCREW RACK IN VOLT PHP CAME APART ON ONE SIDE. DRIVING CAPS FOR TNA NAILS HAD A SET PIN MISSING WHICH DOES NOT KEEP THE SPRING IN PLACE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114742 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE T-HANDLE AND LOCKING MECHANISM AND INTERFACE TO THE FINGER REDUCTION TOOL KEEPS SLIDING OFF. THIS WAS WHILE PERFORMING THE FUNCTION BEFORE ASSEMBLING THE SET BEFORE PROCESSING. THE BACK SLAP POLE THAT HELPS REMOVE THE NAIL (THREADS ARE WORN); IT WILL NOT SCREW INTO THE BACK OF THE EXTRACTION BOLT FULLY. IT WAS NOTICED DURING ROUTINE INSPECTION. THE LID TO THE SCREW RACK IN VOLT PHP CAME APART ON ONE SIDE. DRIVING CAPS FOR TNA NAILS HAD A SET PIN MISSING WHICH DOES NOT KEEP THE SPRING IN PLACE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114724 ↗
• MalfunctionApr 29, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS OF THE TWO INSTRUMENTS WOULD NOT ENGAGE PROPERLY, WITH THE EXTRACTION SCREW THREAD SUSPECTED TO BE DAMAGED PRIOR TO USE. THE HAMMER GUIDE HAD PREVIOUSLY THREADED ONTO ANOTHER INSTRUMENT WITHOUT ISSUE, BUT DURING THE NAIL EXTRACTION PROCEDURE, THE SURGEON WAS UNABLE TO FULLY TIGHTEN THE TWO INSTRUMENTS AS THE THREADS CROSSED. AFTER THE NAIL WAS EXTRACTED, THE INSTRUMENTS COULD NOT BE UNTHREADED AND WERE SENT TO STERILE SERVICES FOR FURTHER HANDLING. THE EVENT RESULTED IN A MINOR SURGICAL DELAY OF APPROXIMATELY 5¿9 MINUTES, WITH THE PROCEDURE OUTCOME REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034338 ↗
• MalfunctionDec 26, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THE PRODUCTS ARE BOTH SCUFFED AND MALLET WILL NOT SLIDE ALONG HAMMER GUIDE ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897245 ↗
• MalfunctionAug 22, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE HAMMER GUIDES THREADS ARE WORE OUT AND WON¿T THREAD INTO THE NAIL EXTRACTOR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872148 ↗
• MalfunctionAug 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE BACKING OUT A TIBIAL NAIL AND HAMMER GUIDE AND DRIVING CAP NOT THREADING INTO EACH OTHER. STAFF OPENED UP ANOTHER SET. NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730122 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE INSPECTED POST-OP AND WERE FOUND BENT AND FUSED TOGETHER. PATIENT WAS UNHARMED AND PROCEDURE WAS SUCCESSFUL FOR IMPLANT REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642100 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT THE METAL OF THE HAMMER GUIDE IS PEELING OFF AND IS NO LONGER SAFE TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566112 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE TWO INSTRUMENTS INVOLVED ARE COMPOSED OF 1 PART EACH. THESE TWO INSTRUMENTS ARE FIRMLY STUCK TOGETHER AND CANNOT BE TAKEN APART FROM EACH OTHER AS PER THE IMAGES ATTACHED. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC 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 IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942337 ↗
• MalfunctionApr 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 , THE THREADS ON THE END OF THE HAMMER GUIDE WERE MESSED UP. IT COULDN¿T THREAD INTO THE HELICAL BLADE REMOVAL PIECE. EVENT OCCURRED POSTOPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926954 ↗
• MalfunctionOct 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL EVENT INFORMATION STATES THAT: - WAS THERE A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT? IF YES, WHAT WAS THE DURATION OF DELAY? YES - HAD TO OPEN A NEW TRAY 5 MINS - WAS THE SURGERY COMPLETED SUCCESSFULLY? (YES OR NO): YES.

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

  MAUDE report 20558044 ↗
• InjuryOct 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2024, A BOX OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20439774 ↗
• MalfunctionAug 12, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A TFNA REMOVAL, THE CONICAL EXTRACTOR WAS USED AND COULD NOT BE UNTHREADED FROM THE NAIL. THE SAME HAPPENED WITH THE HAMMER GUIDE AND MALLETS. ADDITIONALLY, THE REAMERS BROKE IN THE CANALS AND WERE INTRAOPERATIVELY REMOVED BY TAKING OUT THE BALL TIP. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE HAMMER GUIDE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19963545 ↗
• MalfunctionJul 24, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE THREADS WERE DAMAGED AND DO NOT THREAD INTO OTHER DEVICES. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS NO DELAY TO SURGERY. THIS REPORT INVOLVES ONE HAMMER GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816547 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THAT PATIENT UNDERWENT A TRAUMA PROCEDURE ON (B)(6) 2024. DURING THE CASE, THE SURGEON WAS ATTEMPTING TO USE THE BACKSLAP BUT IT WAS NOT STAYING ATTACHED TO THE DRIVING CAP; IT WOULD NOT THREAD IN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE MINUTES. THIS REPORT IS FOR A HAMMER GUIDE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19725310 ↗
• MalfunctionJun 13, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON MAY 20 2024, THE DRIVING CAP AND HAMMER GUIDE WERE THREADED TOGETHER AND UNABLE TO BE REMOVED. THE CASE WAS FINISHED SUCCESSFULLY WITH MINIMAL DELAY. SALES REPRESENTATIVE REQUESTED THE REPLACEMENT DEVICES FOR THESE TWO INSTRUMENTS. THIS REPORT INVOLVES ONE (1) HAMMER GUIDE THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533317 ↗
• MalfunctionJan 22, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL, THE 3.5 HEX WAS STRIPPED DURING REMOVAL. HEAD WAS BENT. NAIL WAS ALSO REMOVED IN CONJUNCTION, A BACK SLAP WAS USED AND UNABLE TO BE THREADED. AFTER REMOVAL PERFORMED, REVISION ORIF WAS DONE AND THE TIP OF THE 2.7 DRILL GUIDE WAS USED TO HARVEST BONE GRAFT AND WAS BENT IN THE PROCESS. NO SURGICAL DELAY WAS REPORTED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1)HAMMER GUIDE. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557167 ↗
• MalfunctionJan 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS AN ISSUE WITH A COUPLE DIFFERENT INSTRUMENTS IN THE FRN (FEMORAL RECON NAIL) SET. WHILE INSERTING THE NAIL, OUR SURGEON STRUCK THE DRIVING CAP AND THE THREADED PORTION BROKE OFF AND BECAME LODGED IN THE INSERTION HANDLE. LUCKILY, THE NAIL WAS ALREADY INSERTED ALL THE WAY SO WE WERE ABLE TO PROCEED WITH THE CASE. IN THE SAME CASE, OUR SURGEON BEGAN DRILLING WITH THE STEPPED DRILL AND NOTICED SOME INTERFERENCE BETWEEN THE DRILL AND THE NAIL. HE CONTINUED TO DRILL AND THEN THE TIP OF THE DRILL BROKE OFF INTO THE PATIENTS FEMORAL NECK. HE WAS ABLE TO RETRIEVE THE BROKEN PIECE AND PROCEED WITH THE CASE, BUT IT CERTAINLY CAUSED A DELAY. THIS REPORT IS FOR ONE (1) HAMMER GUIDE. THIS IS REPORT 2 OF 2 FOR COMPLAINT(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18553608 ↗
• MalfunctionDec 27, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT TFNA HELICAL BLADE COUPLING SCREW HAD DAMAGED THREADS. THE THREADS IN COUPLING SCREW ARE DAMAGED AND HAVING ISSUES WHEN INSERTED INTO HELICAL BLADE. THE THREADS OF HAMMER GUIDE WERE ALSO DAMAGED. THERE ARE THREADS WHICH ARE NOT THREADED PROPERLY. THIS WAS A FIELD EQUIPMENT NOT HOSPITAL. THERE WAS NO PATIENT WAS INVOLVEMENT. BOTH THREADS ARE DAMAGED AND NEED PRODUCT REPLACEMENT. THIS REPORT IS FOR ONE (1) HAMMER GUIDE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399049 ↗
• MalfunctionSep 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING POSTOPERATIVE INSPECTION OF A SET, IT WAS NOTED THAT THE NAIL EXTRACTION AND HAMMER GUIDE WERE COLD-WELDED TOGETHER. THE OTHER INSTRUMENTS WERE NOTED TO BE DEFORMED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAMMER GUIDE THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754988 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE COIL ON THE END OF THE BACKSLAP IS STARTING TO COME OFF. THERE WAS NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) HAMMER GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321624 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, FRN HANDLE WAS BROKEN DURING THE SURGERY. THERE WAS NO EFFECT ON SURGERY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FRN. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319131 ↗
• MalfunctionNov 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIBIAL NAIL ADVANCED WAS USED DURING INTRA OP. BACK SLAP WAS CROSS THREADED INTO HAMMER GUIDE DUE TO OFF AXIS AND MALLET WAS UNABLE TO BE TAKEN OFF. THREADED PORTION OF CONNECTING ELEMENTS WERE STRIPPED. MULTIPLE WIRE GUIDE WAS BENT WITH WIRE. BENDERS WERE USED TO BEND BACK GUIDE BUT DID NOT WORK. TORQUE LIMITERS INTRA OP DID NOT WORK WITH A QC STRYKER DRILL. NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR A HAMMER GUIDE. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833885 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT, TWO NAIL REMOVAL INSTRUMENTS ARE STUCK TOGETHER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) HAMMER GUIDE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319624 ↗
• MalfunctionMay 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022 AN INCIDENT WAS OCCURRED. DURING THE INCIDENT, THE TIBIAL NAIL ADVANCED WAS INSERTED DURING A SUPRAPATELLAR APPROACH. THE PATIENT WAS POSITIONED WITH A BONE FOAM WITH A BUMP UNDERNEATH THE KNEE. AFTER LOCKING DISTALLY, THE BACKSLAP WAS ATTACHED TO THE HAMMER GUIDE AND BACKSLAPPED. DURING BACK SLAPPING, THE BACK SLAP WAS UNABLE TO BE TAKEN OFF. SURGERY PROCEEDED, AND S1 WAS DRILLED. THE DRILL BIT HIT THE NAIL FOR S1, SO PULLING FORCES WERE ENGAGED ON THE AIMING ARM TO RELIEVE PRESSURE AND DRILL BIT HITTING POSTERIOR. HAMMER GUIDE WAS UNABLE TO BE TAKEN OFF WITH BACKSLAP ATTACHED INTRA OP, AND AIMING ARM HAD A SLIGHT CRACK AFTER REMOVAL. THERE WAS 6 MINS OF SURGERY DELAYED DUE TO THE REPORTED EVENT. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS FOR ONE (1) HAMMER GUIDE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14430736 ↗