NA 357.405Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982196286), received between Dec 14, 2016 and Oct 2, 2020 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON SEPTEMBER 23, 2020, THAT DURING A SURGERY, WHEN USING TFN STEP DRILL BIT THROUGH ACETABULUM THE FIXATION SLEEVE WAS FAILED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY REPORTED. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) DRILL STOP. THIS IS REPORT 1 OF 2 FOR PC (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10621228 ↗
• MalfunctionMar 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STEPPED DRILL BIT IN QUESTION DOESN'T FIT IN THE MOTOR SINCE THE PROXIMAL PART IS WORN OUT. THERE IS NO CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) DRILL STOP. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9824817 ↗
• MalfunctionOct 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE STOPPER DOES SLIP ON THE DIRT BIT. IT IS UNKNOWN THAT WHEN AND IT IS UNKNOWN WHEN THE DAMAGE OCCURRED. THERE ARE NO PATIENT CONSEQUENCES. THIS IS REPORT FOR 01 OF 02 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202404 ↗
• MalfunctionNov 13, 2018Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT AN UNKNOWN TRAUMA SURGICAL PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE, THE DRILL STOP FAILED TO STOP THE DRILL AT THE PRE-MEASURED DEPTH. SURGEON WAS ABLE TO DRILL CORRECTLY WITHOUT INCIDENT. PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. THIS REPORT IS FOR ONE (1) DRILL STOP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8065963 ↗
• MalfunctionOct 8, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STEPPED CANNULATED REAMER AND THE FIX SLEEVE OR DRILL STOP FROM THE TROCHANTERIC FIXATION NAIL (TFN) LOCKING SET WERE NOT WORKING PROPERLY. THEY WERE WORN AND DAMAGED, AND THE DRILL STOP SLIDES DID NOT STAY IN PLACE PROPERLY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE: TFN LOCKING SET (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A DRILL STOP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7942781 ↗
• MalfunctionMar 22, 2018Unintended Movement; Unintended Movement

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DRILL STOP CONNECTION SCREW DOES NOT HOLD THE WICK. THIS ISSUE CAUSES INACCURATE MEASUREMENTS. SCRATCHES WERE ALSO NOTED ON THE DRILL BIT AND SLEEVE OF THE CONNECTION DEVICE. NO PATIENT OR SURGERY INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) DRILL STOP THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7362840 ↗
• InjuryOct 24, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED DURING AN INITIAL (TFN) TROCHANTERIC FIXATION NAIL PROCEDURE ON (B)(6) 2017, A DRILL STOP SLIPPED DURING DRILLING AND CAUSED THE SURGEON TO DRILL DEEPER THAN PLANNED. THE EXTRA DRILLING WENT INTO THE FEMORAL HEAD. NO DEVICES BROKE. THE PROCEDURE WAS COMPLETED BY USING THE SAME DRILL BIT AND DRILL STOP WITH EXTRA CAUTION TO HOLD THE DRILL STOP. IT WAS ALSO REPORTED THAT DURING THE SAME SURGERY THE BUTTRESS NUT DEVICE DID NOT SEAT PROPERLY AND CAUSED THE TROCHAR GUIDE TO POP OUT. NO SURGICAL DELAY WAS REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT IS LISTED AS STABLE. CONCOMITANT DEVICES REPORTED: DRILL BIT (PART# 357.403, LOT# UL15712, QTY 1), BLADE GUIDE (PART# 357.369, LOT# UNK, QTY 1). THIS REPORT IS FOR ONE (1) DRILL STOP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6974522 ↗
• MalfunctionSep 1, 2017Incorrect Measurement; Device Operates Differently Than Expected; Incorrect Measurement; Device Operates Differently Than Expected

  IT WAS REPORTED THAT PATIENT UNDERWENT THE PROCEDURE FOR AN INTERTROCHANTERIC HIP FRACTURE. DURING THE PROCEDURE, TFNA INSTRUMENTS WERE BEING USED AND THE SURGEON PREPARED TO IMPLANT A HELICAL BLADE INTO THE PATIENT. PRIOR TO IMPLANTATION, THE SURGEON HAD ALL NECESSARY INSTRUMENTS PREPARED ON THE BACK TABLE FOR IMPLANTATION. IT WAS OBSERVED THAT WHEN THE DRILL STOP COMES INTO CONTACT WITH THE TROCAR, THE DRILL STOP GOES BEYOND WHAT IT IS SET FOR. THIS WAS DETERMINED ON THE BACK TABLE DURING SURGERY. THERE IS NO PATIENT INJURY, BUT THE REPORTED MALFUNCTION WAS DISCOVERED WHEN THE PATIENT WAS IN THE ROOM. NO VISIBLE WEAR NOTICED ON THE DRILL BIT. THERE WAS ANOTHER TFNA INSTRUMENT/IMPLANT SET AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT IS IN STABLE CONDITION. CONCOMITANT DEVICES REPORT: TROCAR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: 1); INSERTION HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: 1); DRILL BIT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: 1); DRILL STOP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) DRILL STOP. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6837612 ↗
• MalfunctionMar 5, 2017Failure To Adhere Or Bond; Device Operates Differently Than Expected; Failure To Adhere Or Bond; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE DRILL STOP DID NOT AFFIX PROPERLY TO THE STEPPED DRILL BIT ALLOWING IT TO SLIP DURING DRILLING. THIS RESULTED IN DRILLING TO A DEEPER DEPTH THEN INTENDED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPOT OF PATIENT HARM. CONCOMITANT DEVICE: PART 357.403, STEPPED DRILL BIT, LOT UNKNOWN, QTY 1. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6379583 ↗
• MalfunctionFeb 16, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION, FIVE DEVICES WERE IDENTIFIED TO BE NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. TORQUE LIMITING ATTACHMENT WAS NOT HOLDING DRIVE SHAFT, HANDLE FOR TORQUE LIMITING ATTACHMENT WAS MISSING SET SCREW, INTERLOCKING BOLT HAD THREADS HEAVILY DAMAGED AND WILL NOT ENGAGE INTO PLATE, CANNULATED STEPPED DRILL BIT HAD TIP SHEARED OFF AND WILL NOT GO OVER GUIDE WIRE AND THE TIP WAS BROKEN, DRILL STOP WILL NOT STOP AND SLIDES ON DRILL. THE PLATE WAS WORKING FINE. CONCOMITANT DEVICES REPORTED: PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), GUIDE WIRE (PART # 357.399, LOT # UNKNOWN, QUANTITY # 1), DRILL (PART # 357.403, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6336080 ↗
• MalfunctionFeb 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT STOP, MALFUNCTIONED DURING A SURGICAL PROCEDURE. THE DRILL BIT DOES NOT STOP AT THE DESIRED CHOSEN DEPTH, PRIOR TO DRILLING THE FEMORAL NECK. THERE WAS NO REPORTED HARM TO THE PATIENT, NO SURGICAL DELAY, AND NO FRAGMENTS WERE GENERATED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QTY.1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6335632 ↗
• MalfunctionFeb 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT IS REPORTED THE DRILL STOP IS NO LONGER STOPPING THE DRILL BIT. THE ISSUE WAS DISCOVERED IN STERILE PROCESSING WHEN TESTING THE DEVICE AFTER CLEANING. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. CONCOMITANT DEVICES REPORTED: DRILL BIT (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6327897 ↗
• MalfunctionFeb 6, 2017Fitting Problem; Fitting Problem

  UPDATE 03 FEB 2017: ¿IT WAS REPORTED THAT THE DRILL STOP DOESN¿T CLICK CORRECTLY AND DOESN¿T STAY IN PLACE. THE ISSUE OCCURRED ON (B)(6) 2016 PRIOR TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT AND NO ISSUES WITH THE SMALL BATTERY DRIVE. PROCEDURE WAS SUCCESSFULLY COMPLETED.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6304042 ↗
• MalfunctionDec 14, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN COUNTRY AS FOLLOWS: (B)(6) REPORTED THE FOLLOWING: A PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE ON (B)(6) 2016. WHILE THE SURGEON WAS DRILLING WITH AN 11.0MM TAPERED CANNULATED DRILL AND DRILL STOP, HE NOTICED THAT THE DRILL STOP WAS SLIDING ALONG THE DRILL BIT. ALTHOUGH THE DRILL STOP WAS MOUNTED CORRECTLY ON THE DRILL BIT, THE CLOCKING MECHANISM SEEMED TO BE DEFECTIVE. THE FEMORAL HEAD HAD NOT BEEN VIOLATED BUT IF THE SURGEON WOULDN¿T HAVE NOTICED THE PROBLEM ON TIME, IT COULD HAVE HAPPENED. THE DEFECTIVE INSTRUMENT IS MOST PROBABLY THE DRILL STOP. THIS DRILL IS NOT OFTEN USED AND IT SEEMS TO BE IN GOOD CONDITION. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION AND NO SURGICAL TIME DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS OUTCOME IS VERY GOOD. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT DEVICE REPORTED: UNKNOWN 11.0MM TAPERED CANNULATED DRILL ¿ PART# - UNKNOWN, LOT# - UNKNOWN, QUANTITY# - 1. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6173889 ↗