NA 03.043.028Recalls & reported problems

Summary

The FDA's MAUDE database contains 282 adverse event reports that list this exact device (DI 10886982297389), received between Jan 18, 2022 and Sep 30, 2026 — classified as 282 malfunctions.

The most frequently reported specific device problem is “Break” (175 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 282 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device-Device Incompatibility

  It was reported that the TNA driving cap became stuck and lodged in the insertion handle. Cannot remove once inserted. There was no patient harm or delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946309 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717788 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED WHEN IMPACTING THE NAIL THE SET PIN CASE APART ON THE IMPACTION DRIVE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183708 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT STRIKING CAP BROKE. THERE WAS NO PATIENT HARM AND NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094945 ↗
• MalfunctionMay 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE INSERTING THE TIBIA NAIL, THE PIN CAME OUT OF THE DRIVING CAP, AND THE DRIVING CAP CAME APART. THE PIN WAS LOCATED ON THE FLOOR OF THE OPERATING ROOM. THE PATIENT WAS NOT IMPACTED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068684 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED ON (B)(6) 2026, DURING A PROCEDURE TWO DEVICES BROKE. WHEN THEY WERE CLIPPING THE AIMING ARM ON, A PIECE OF THE CARBON FIBER BROKE OFF. ON INSERTION OF THE TIBIAL NAIL, THE METAL PIN ON THE IMPACTOR BROKE AND THE SPRING FELL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058653 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING TNA, THE TNA HAMMER GUIDE BROKE INTRA OP. 8 MM MONOBLOC REAMER BROKE AS WELL. NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871856 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT THE DRIVING CAP FELL APART DURING AN ORTHOPEDIC PROCEDURE. THE SURGEON WAS INSERTING A TIBIAL NAIL AND, WHILE FOLLOWING INSTRUCTIONS, THE IMPACTOR BROKE INTO MULTIPLE PIECES. THE BROKEN FRAGMENTS WERE COLLECTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ONLY A TWO-MINUTE DELAY. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND THE FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801819 ↗
• MalfunctionMar 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT A TRAUMA PROCEDURE ON (B)(6) 2026. THE PIN IN THE TIBIAL NAIL IMPACTOR HAD BACKED OUT AND THE IMPACTOR NEEDS TO BE REPLACED. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701924 ↗
• MalfunctionMar 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THE PIN ON THE IMPACTION CAP FOR A TIBIA NAIL ADVANCE FELL OUT MAKING THE IMPACTION CAP NOT WORK AS ADVERTISED. NO SURGICAL DELAY. NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615477 ↗
• MalfunctionMar 9, 2026Break; Device Slipped

  ADDITIONAL INFORMATION RECEIVED: A. DATE OF EVENT (IF AVAILABLE) - SOMETIME IN BEGINNING OF FEBRUARY. B. WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP) - INTRA-OP. SURGEON MADE A COMPLAINT DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544091 ↗
• MalfunctionFeb 23, 2026Break; Mechanical Problem

  IT WAS REPORTED THE DRIVING CAP IS NOT WORKING AS INTENDED. IT IS BROKEN AND THE SPRING IS NOT FUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24418536 ↗
• MalfunctionFeb 18, 2026Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, WHILE THE SURGEON IMPACTS THE TNA DRIVING CAP USING A HAMMER, THERE IS A SMALL CIRCULAR PIN THAT GETS LOOSE. AS MORE FORCE IS APPLIED, THE PIN CAN FALL OUT AND DISASSEMBLE THE DRIVING CAP ALTOGETHER. IF LEFT UNNOTICED, THE PIN CAN GET LOST DURING THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 2MINS OF DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378585 ↗
• MalfunctionFeb 18, 2026Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, WHILE THE SURGEON IMPACTS THE TNA DRIVING CAP USING A HAMMER, THERE IS A SMALL CIRCULAR PIN THAT GETS LOOSE. AS MORE FORCE IS APPLIED, THE PIN CAN FALL OUT AND DISASSEMBLE THE DRIVING CAP ALTOGETHER. IF LEFT UNNOTICED, THE PIN CAN GET LOST DURING THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 2MINS OF DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378071 ↗
• MalfunctionFeb 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE METAL HOLDING BAR IN THE STRIKING PLATE DISLODGED WHILE THE DEVICE WAS BEING INSERTED WITH HAMMER BLOWS. THE ISSUE WAS NOTICED DURING THE PROCEDURE, AND ALTHOUGH THE METAL BAR COULD BE TAPPED BACK IN, IT IMMEDIATELY DISLODGED AGAIN WITH USE. THE SURGERY WAS COMPLETED WITHOUT DELAY, NO FRAGMENTS WERE GENERATED, AND THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293419 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT THE DRIVING CAP FOR TIBIAL NAIL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261018 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED MULTIPLE DEVICES ARE NO LONGER FUNCTIONAL. THESE ISSUES DID NOT IMPACT PATIENT OUTCOMES. BELOW DEVICES WERE FOUND TO BE "RELEASE MECHANISM BROKEN" DURING INSPECTION: 03.043.028. BELOW DEVICES WERE FOUND TO BE "STRIPPED THREADS" DURING INSPECTION: 03.120.022 312.648 323.029 BELOW DEVICES WERE FOUND TO BE "NUT STUCK ON SLEEVE" DURING INSPECTION: 03.037.017 03.037.016 BELOW DEVICES WERE FOUND TO BE "HANDLE LEACHING/SPD WIL NOT STERILIZE" DURING INSPECTION: 03.100.018 BELOW DEVICES WERE FOUND TO BE "BROKEN HANDLE" DURING INSPECTION: 311.43 BELOW DEVICES WERE FOUND TO BE "STRIPPED DRILL CONNECTION AND 2ND IS COLD WELDED TO A SCHANZ PIN" DURING INSPECTION: 393.103 BELOW DEVICES WERE FOUND TO BE "BROKEN SLIDING MECHANISM" DURING INSPECTION: 319.091 BELOW DEVICES WERE FOUND TO BE "NOT SNAPPING IN" DURING INSPECTION: 03.120.018 03.120.017 BELOW DEVICES WERE FOUND TO BE "STRIPPED" DURING INSPECTION: 03.010.151 314.467 03.900.042 03.130.010 314.453 03.010.150 03.010.152. BELOW DEVICES WERE FOUND TO BE "NOT WORKING PROPERLY" DURING INSPECTION: 329.15 BELOW DEVICES WERE FOUND TO BE "NOT LOCKING TENSION BETWEEN TRIGGER PULLS" DURING INSPECTION: 03.221.015 BELOW DEVICES WERE FOUND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183185 ↗
• MalfunctionJan 21, 2026Device Slipped

  IT WAS REPORTED DURING SURGERY THE PAL AND SPRING LOOSED AND THE INSTRUMENT IS DAMAGED AND NO LONGER FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129440 ↗
• MalfunctionJan 20, 2026Device-Device Incompatibility

  INSTRUMENTS CAN NO LONGER BE SEPARATED FROM EACH OTHER. REGONGNZED AT THE DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122607 ↗
• MalfunctionJan 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT THERE WERE SEVERAL INSTRUMENTS THAT WERE EITHER DAMAGED OR HAD ISSUES AND WERE IN NEED OF REPLACEMENT. THE INSTRUMENTS THAT WERE DAMAGED, THEY WERE NOT SURE WHEN THE DAMAGE OCCURRED. SOME OF THE INSTRUMENTS THAT HAD ISSUES HAVE THINGS LIKE RUST IN THE CANNULATION AREAS AND OR THE GRAPHICS CASE WAS BENT BEYOND REPAIR AND/OR WAS FLAKING OFF THE COATING ON THE CASE. THERE WAS NO PATIENT INVOLVEMENT FOR ANY OF THESE ITEMS. 1. PRODUCT # 03.043.028, LOT # 22234101, QUANTITY 1. THIS ITEM IS AN IMPACT FOR THE ANS SYSTEM IN THE PIN THAT IS WELDED HAS COME APART, SO THE PIN IS FLOATING FREE. 2. PRODUCT # 319.09, LOT # 8774P99, QUANTITY 1. THIS ITEM IS A DEPTH GAUGE, AND THERE IS RUST ON PART OF THE DEPTH GAUGE THEY WILL NOT COME OFF. 3. PRODUCT # 03.010.495, LOT # PE05189, QUANTITY 1. THIS ITEM IS A REDUCTION TOOL AND IS CANNULATED WITH RUST ON THE INSIDE OF THE CANNULATION. 4. PRODUCT # 60.527.015, LOT # UNKNOWN, QUANTITY 1. THIS ITEM IS A SCREW RACK AND IS BENT WITH THE LID, UNABLE TO BE LOCKED AND WAS DISPOSED OUT BY THE FACILITY. 5. PRODUCT # 60.333.200, LOT # UNKNOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122505 ↗
• MalfunctionJan 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT TNA DRIVE CAP PIN CAME OUT WHEN MALLETING. VOLT BLUE HANDLE BROKE WHEN COUNTERSINKING. 11MM WRENCH BROKE WHEN TIGHTENING RFNA CAP. ALSO HAD TWO 2.5MM HEX STRIP AND TWO MEDIUM LOBSTER CLAW SPINDLE BENT. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059621 ↗
• MalfunctionJan 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT TNA DRIVE CAP PIN CAME OUT WHEN MALLETING. VOLT BLUE HANDLE BROKE WHEN COUNTERSINKING. 11MM WRENCH BROKE WHEN TIGHTENING RFNA CAP. ALSO HAD TWO 2.5MM HEX STRIP AND TWO MEDIUM LOBSTER CLAW SPINDLE BENT. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059615 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE DRIVING CAP PIN WELD BROKE POST SURGERY. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055730 ↗
• MalfunctionJan 8, 2026Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGERY, THE PAL AND SPRING LOOSENED AND THE INSTRUMENT WAS DAMAGED AND NO LONGER FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010283 ↗
• MalfunctionJan 2, 2026Break

  IT WAS REPORTED THAT A TNA DRIVING CAP BROKE AND GREEN TROCAR BENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945227 ↗