NA 357.372Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10886982196064), received between Dec 20, 2016 and Jul 19, 2021 — classified as 1 injury, 58 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE HELICAL BLADE INSERTER WAS DEFECTIVE; STILL OPERATIONAL BUT DEFECTIVE. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN. THIS REPORT IS FOR A HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188681 ↗
• MalfunctionMar 24, 2021Device-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 UNKNOWN T- SHAPE SCREW DOESN'T LOCK ANYMORE ON HANDLE AND THE HANDLE LOOSENS. IT IS UNKNOWN IF THERE WAS A PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563441 ↗
• MalfunctionJan 7, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT AN IMPACTOR FOR HELICAL BLADE FOR TROCHANTERIC FIXATION NAILS (TFN). WAS BROKEN. THIS REPORT IS FOR A HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11134616 ↗
• MalfunctionOct 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE IMPACTOR F/HELICAL BLADE F/TFN IS DAMAGED. IT CANNOT BE TAKEN APART, LOCK DOES NO RETRACT. NO OTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS FOR 1 HELICAL BLADE INSERTER THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10742617 ↗
• MalfunctionSep 25, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIGHTENING SCREW ON THE HELICAL BLADE IMPACTOR IS BROKEN OFF, NOT ALLOWING IT TO BACK OUT AND FOR THE WING AND GOLD SLEEVE TO BE REMOVED FOR CLEANING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN SLEEVE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1). THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10588198 ↗
• MalfunctionSep 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE IMPACTOR FOR THE HELICAL BLADE WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE AND THE PIN IN THE THREE (3) PRONGED END PIECE WAS DAMAGED. PATIENT INVOLVEMENT IS UNKNOWN. THIS REPORT INVOLVES ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535080 ↗
• MalfunctionApr 20, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DISTAL RADIUS FIXATOR CASE IS BROKEN WITH A HOLE IN THE BOTTOM. THE LCP SMALL FRAGMENT SET IS HAVING PROBLEM WITH THE PAINT PEELING OF IN SOME PART OF THE TRAY. THE DEPTH GAUGE MEASURING EXTREMITY IS BROKEN AND SEPARATE FROM THE MEASURING DEVICE. THE HELICOIDAL BLADE INSERTER CAN'T BE ASSEMBLE ANYMORE SINCE THE 3 SPIKES END IS BROKEN. ONE SPIKE IS BROKE AND THE ONE YOU SCREW WILL NOT SCREW ANYMORE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9979202 ↗
• MalfunctionApr 16, 2020Break; Break

  IT WAS REPORTED THAT ON MARCH 24, 2020, THE HELICAL BLADE INSERTER WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968146 ↗
• MalfunctionApr 6, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE SCREW IN THE WING OF A TROCHANTERIC FIXATION NAIL (TFN) HELICAL BLADE INSERTER IS IMPACTED AND BROKE OFF WHEN TRYING TO REMOVE IN CLEANING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9930566 ↗
• MalfunctionApr 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) HELICAL BLADE INSERTION ON (B)(6) 2020, THE TOP OF THE COUPLING SCREW BROKE WHILE IT WAS BEING STRUCK BY A MALLET. PART OF THE TFN COUPLING SCREW BECAME INCARCERATED WITHIN THE HELICAL BLADE INSERTER. THE HELICAL INSERTER COULD NOT BE REMOVED INDEPENDENTLY AND COULD NOT BE DISCONNECTED FROM THE AIMING ARM EITHER. THEREFORE, THE WHOLE CONSTRUCT WAS BACKED OUT AND ANOTHER SET WAS OPENED TO PLACE IN A NEW IMPLANT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TWENTY-FIVE (25) MINUTES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A HELICAL BLADE INSERTER. CONCOMITANT DEVICES: TFN HELICAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), AIMING ARM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), MALLET (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), COUPLING SCREW (PART: 357.377, LOT: UNKNOWN, QUANTITY: 1) THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9924464 ↗
• MalfunctionMar 27, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT DURING THE SURGERY THE SURGEON HAMMERED ON THE HELICAL BLADE IMPACTOR AND CONNECTING SCREW AND BOTH PIECES SEPARATED INTO THEIR INDIVIDUAL COMPONENTS. ALL PIECES WERE ACCOUNTED FOR WITH A SHORT SURGICAL DELAY. NO PATIENT ISSUES. CONCOMITANT PRODUCT: UNKNOWN HAMMER/MALLET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9889802 ↗
• MalfunctionFeb 20, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, ONE (1) HELICAL BLADE INSERTER, SIX (6) LOCKING BOLT MEASURING DEVICE AND TWO (2) DEPTH GAUGE FOR LOCKING SCREW WERE BROKEN AND ONE (1) HELICAL BLADE INSERTER DOES NOT FUNCTION DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. DURING MANUFACTURER'S PRELIMINARY EVALUATION OF THE RECEIVED DEVICE IT WAS IDENTIFIED THAT A HELICAL BLADE INSERTER IS MISSING COMPONENTS. THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 10 OF 10 (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9735106 ↗
• MalfunctionJan 29, 2020Break; Break

  THIS IS REPORT 1 OF 10 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9642641 ↗
• MalfunctionJan 14, 2020Device-Device Incompatibility; Device-Device Incompatibility

  UPDATED 1/6/2020: IT WAS REPORTED THAT THE ISSUE WAS DISCOVERED PRE-OPERATIVELY. THE SCRUB WAS SETTING UP THE BACK TABLE BEFORE SURGERY STARTED. IT WAS DISCOVERED THAT THE PIECE WAS NOT FUNCTIONING, AND ANOTHER SET WAS OPENED TO USE FOR THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9587612 ↗
• MalfunctionJan 8, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE FASTENING SCREW SNAPPED OFF OF THE HELICAL BLADE INSERTER. CONCOMITANT DEVICE: UNKNOWN SCREWS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565410 ↗
• MalfunctionNov 6, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE HELICAL BLADE INSERTER WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4)..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9286069 ↗
• MalfunctionSep 20, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE FOR PATIENT'S TREATMENT USING WITH AN UNKNOWN TROCHANTERIC FIXATION NAIL (TFN), FOLLOWING AN INSERTION OF AN UNKNOWN HELICAL BLADE, WHILE DISCONNECTING THE INSTRUMENT FROM AN UNKNOWN AIMING ARM, IT WAS DISCOVERED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED BY STERILE PROCESSING DEPT AFTER ITS LAST USE. THE PROCEDURE WAS COMPLETED BY INSERTING AN UNKNOWN DISTAL LOCKING SCREW AND REMOVING THE INSTRUMENTS WITHOUT INCIDENT. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN HELICAL BLADE (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY 1); UNKNOWN AIMING ARM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); UNKNOWN DISTAL LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) AND UNKNOWN TFN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9098949 ↗
• MalfunctionJun 24, 2019Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING REGULAR CLEANING OF THE TFN HELICAL BLADE INSERTION HANDLE IT WAS NOTICED THAT THE N55 WAS UNABLE TO BE TAKEN OFF FROM THE HANDLE AND THEREFORE THE INSERTION HANDLE/HELICAL BLADE INSERTER WAS NOT ABLE TO DISASSEMBLE PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN TFN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS REPORT IS FOR 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8729074 ↗
• MalfunctionJun 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, AFTER A HIP SURGERY THREE (3) HELICAL BLADE INSERTERS LEGGED ENDS WERE HARD TO DISASSEMBLE MAKING IT IMPOSSIBLE TO CLEAN. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8723408 ↗
• MalfunctionJun 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, AFTER A HIP SURGERY THREE (3) HELICAL BLADE INSERTERS LEGGED ENDS WERE HARD TO DISASSEMBLE MAKING IT IMPOSSIBLE TO CLEAN. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8723381 ↗
• MalfunctionJun 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, AFTER A HIP SURGERY THREE (3) HELICAL BLADE INSERTERS LEGGED ENDS WERE HARD TO DISASSEMBLE MAKING IT IMPOSSIBLE TO CLEAN. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8723332 ↗
• MalfunctionMay 23, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019. DURING AN UNKNOWN PROCEDURE, THE HELICAL BLADE INSERTER WOULD NOT FIT THROUGH THE BLADE GUIDE SLEEVE. THEY COULD NOT FIGURE OUT WHICH PIECE CAUSED THE ISSUE. THE BLADE GUIDE SLEEVE MIGHT HAVE HAD THE HOLES AT THE WRONG SPOT OR IT COULD HAVE BEEN DAMAGED ON THE HELICAL INSERTER. THE SURGEON USED A FREE HAND TO INSERT THE BLADE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636919 ↗
• MalfunctionApr 10, 2019Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2019, THE HELICAL BLADE INSERTER WAS BROKEN. IT DID NOT CAUSE ANY HARM TO THE PATIENT BUT THE INSTRUMENT IS NOT USEFUL RIGHT NOW. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED FROM A BROKEN DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8502008 ↗
• MalfunctionFeb 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING HIP FRACTURE SURGERY ON (B)(6) 2019, THE HELICAL BLADE INSERTER AND HELICAL BLADE COUPLING SCREW WOULD NOT COUPLE TO HELICAL BLADE. THERE WAS A SURGICAL DELAY OF THREE (3) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BECAUSE THE SURGEON USED ANOTHER SET. PATIENT STATUS REPORTED AS PROCEEDED WITHOUT INCIDENT. THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8372141 ↗
• MalfunctionFeb 22, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE INNER SLEEVE OF A HELICAL BLADE INSERTER WAS DEFORMED AND WOULD NOT COLLECT PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361699 ↗