NA 03.037.120Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982070586), received between Sep 25, 2018 and Sep 14, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break; Corroded; Material Twisted/Bent

  It was reported several instruments were found broken, stripped, and rusted. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754610 ↗
• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A TRAUMA PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE TFNA IMPACTOR BROKE WHERE THE THREADS ENGAGE THE IMPACTOR CONNECTING PIECE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125705 ↗
• MalfunctionApr 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ITEMS JAMMED TOGETHER. IT APPEARS THAT THEY HAVE BECOME CROSS THREAD INTRA-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780684 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A DRIVING CAP BROKE DURING A TFNA CASE. THE THREADED TIP BROKE OFF DURING NAIL INSERTION. THE SURGEON FINISHED THE CASE WITHOUT IT. ALL PIECES WERE RECOVERED, AND NO HARM WAS DONE TO THE PATIENT. THE CASE WAS FINISHED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112731 ↗
• MalfunctionAug 11, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE THREADS OF THE CONNECTOR ARE WORN OUT. THE DRIVER CAP CANNOT BE INSERTED. THERE WAS A SURGICAL DELAY OF ONE MINUTE. A REPLACEMENT CONNECTOR WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514451 ↗
• MalfunctionJul 17, 2023Break; Break

  IT WAS REPORTED THAT ON JUNE 1, 2023, THE ITEM WAS FOUND BROKEN WHEN PUTTING THE SETS TOGETHER DURING THE CASE. ANOTHER TFNA SET WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333585 ↗
• MalfunctionMay 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREADED GUIDE SLEEVE AND COMPRESSION NUT DID NOT PROPERLY THREAD INTO EACH OTHER, THREADS WERE DAMAGED. HAMMER GUIDE AND DRIVING CAP DID NOT SECURELY ATTACH TO AIMING ARM, REMAINS LOOSE WHEN FULLY THREAD. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003135 ↗
• MalfunctionMar 8, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTATION WAS BROKEN TODAY, NO SURGICAL DATE PROVIDED. IT WAS UNKNOWN, IF THERE WAS A PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) CONNEC F/DRIVING CAP. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504011 ↗
• MalfunctionOct 31, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE PERFORMING A SYNTHES TFNA, THE DAMAGE TO THE THREADS ON THE DRIVING CAP AND GUIDE CONNECTOR IN QUESTION PREVENTED THE SURGEON FROM ATTACHING THE DRIVING CAP AND REQUIRED THE USE OF ANOTHER SET. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698594 ↗
• MalfunctionMay 9, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DRIVING CAP THREADS WERE BROKEN OFF INTO DRIVE CAP CONNECTOR DURING NAIL INSERTION. THE BROKEN PORTION COULD NOT BE REMOVED FROM CONNECTOR AND DRIVE CAP WAS PERMANENTLY BROKEN. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. ALSO, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED. THERE WAS NOT ANY ADVERSE CONSEQUENCE TO THE PATIENT RELEVANT TO THIS EVENT. THIS REPORT INVOLVES ONE THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338674 ↗
• MalfunctionOct 27, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE ATTACHMENT PIECE OF SCALPED HAMMER FELL OFF ON THE FLOOR AND THE TIP BROKE OFF. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12703934 ↗
• MalfunctionSep 17, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE INSERTION OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL USING A MALLET THE THREADED HAMMER GUIDE CONNECTOR SNAPPED OFF INSIDE THE DRIVING CAP/THREADED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN MALLET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN TFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487397 ↗
• MalfunctionAug 3, 2021Break; Break

  IT WAS REPORTED ON (B)(6) 2021, THE THREADED HAMMER GUIDE CONNECTOR AND DRIVING CAP/THREADED WERE NOTICED BROKEN AFTER SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1)THREADED HAMMER GUIDE CONNECTOR. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267353 ↗
• MalfunctionJul 29, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE CLEANING PROCESS, THE INSERTION HANDLE WAS BROKEN. IT WAS OBSERVED WHILE PUTTING SETS BACK TOGETHER AFTER THEY WERE PUT THROUGH WASH. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) THREADED HAMMER GUIDE CONNECTOR. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249657 ↗
• MalfunctionJul 7, 2020Break; Break

  IT WAS REPORTED THAT DURING AN INTERTROCHANTERIC SURGERY WITH TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) ON (B)(6) 2020, THE THREADED HAMMER GUIDE CONNECTOR AND DRIVING CAP WERE BROKEN OFF DUE TO WEAR AND TEAR. IT WAS MENTIONED THAT THE DRIVING CAP TIP BROKE WHILE BEING STRUCK ON THE BACKSIDE WITH THE HAMMER. A BROKEN FRAGMENT WAS GENERATED AND REMOVED EASILY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN HAMMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10240809 ↗
• MalfunctionMay 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE DRIVING CAP WOULD NOT SEAT FULLY ON THE THREADED HAMMER GUIDE CONNECTOR. THE SURGEON USED THE ASSEMBLY IN THE PARTIAL SEATED POSITION TO INSERT THE NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY REPORTED. CONCOMITANT DEVICES REPORTED: TFNA NAIL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), THREADED HAMMER GUIDE CONNECTOR (PART NUMBER 03.037.120, LOT L735215, QUANTITY 1), DRIVING CAP/THREADED (PART NUMBER 03.010.523, LOT L759641, QUANTITY 1). THIS REPORT INVOLVES 1 THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10065013 ↗
• MalfunctionMay 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE DRIVING CAP WOULD NOT SEAT FULLY ON THE THREADED HAMMER GUIDE CONNECTOR. THE SURGEON USED THE ASSEMBLY IN THE PARTIAL SEATED POSITION TO INSERT THE NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY REPORTED. CONCOMITANT MEDICAL PRODUCTS: TFNA NAIL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). DRIVING CAP/THREADED (PART NUMBER 03.010.523, LOT L759641, QUANTITY 1). THREADED HAMMER GUIDE CONNECTOR (PART NUMBER 03.037.120, LOT 9113148, QUANTITY 1). THIS REPORT INVOLVES ONE (1) THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10064997 ↗
• MalfunctionApr 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, WHILE THE SURGEON WAS INSERTING THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA), THE DRIVING CAP THREADED BROKE AT THE THREADS. THIS CAUSED THE THREADED HAMMER GUIDE CONNECTOR TO BECOME STUCK ON THE COMPLETE RADIOLUCENT INSERTION HANDLE. THE SURGEON THEN USED THE NAIL EXTRACTOR AS A TAMP TO FINISH OFF INSERTING THE NAIL. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: COMPLETE RADIOLUCENT INSERTION HANDLE (PART NUMBER 03.037.012, LOT 9519828, QUANTITY 1), DRIVING CAP/THREADED (PART 03.010.523, LOT 9519944, QUANTITY 1), NAILS: TFNA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN. THIS REPORT INVOLVES ONE (1) THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9982716 ↗
• MalfunctionMar 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING HIP SURGERY, THE DRIVING CAP DID NOT THREAD INTO THE FITTING PROPERLY. EVEN THOUGH, THE DRIVING CAP WAS NOT THREADED ALL THE WAY IN, THE SURGEON MALLETED THE DRIVING CAP. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: MALLET (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), INSERTION HANDLE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9866422 ↗
• MalfunctionDec 18, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS MALLEATING IN A TFNA SHORT NAIL, THE DRIVING CAP WITH THREAD (03.010.523) BROKE AT THE THREADING INTO THE CONNECTOR FOR THE DRIVING CAP (03.037.120). THERE WAS NO SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOMES ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: COMPLETE RADIOLUCENT INSERTION HANDLE (PART#: 03.037.012, LOT#: UNKNOWN, QUANTITY# 1), SPIRAL COMBINATION HAMMER 500 GRAMS (PART#: 03.010.522, LOT#: UNKNOWN, QUANTITY# 1), UNKNOWN TFNA SHORT NAIL (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9487463 ↗
• MalfunctionMar 28, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE TWO (2) DRIVING CAP/THREADED AND TWO (2) THREADED HAMMER GUIDE CONNECTOR WERE BROKEN. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460872 ↗
• MalfunctionMar 28, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6_ 2019, DURING AN UNKNOWN PROCEDURE, THE TWO (2) DRIVING CAP/THREADED AND TWO (2) THREADED HAMMER GUIDE CONNECTOR WERE BROKEN. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460870 ↗
• MalfunctionSep 25, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING A STERILE SUPPLY, THE THREADS OF THE IMPACTOR AND THREADED HAMMER GUIDE WERE DISCOVERED AS BROKEN. THERE WAS NO SURGICAL OR PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7907483 ↗