NA 357.377Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10886982196088), received between Dec 19, 2016 and Oct 14, 2022 — classified as 5 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2022Break; Entrapment of Device; Device-Device Incompatibility; Material Deformation; Break; Entrapment of Device; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING TROCHANTERIC FIXATION NAIL (TFN) REMOVAL CASE, THE T HANDLE FOR REMOVAL OF THE LAG SCREW AND THE CONNECTING PIN WERE DAMAGED. THE TFN NAIL WAS UNABLE TO BE REMOVED DUE TO THIS DAMAGE LEADING PATIENT BEING CLOSED WITHOUT THE NAIL BEING REMOVED. THERE WAS DIFFICULTY GETTING THE ¿FLATS¿ OF THE T HANDLE TO ¿MATE¿ PROPERLY WITH THE END OF THE LAG SCREW. DUE TO THIS THE FLATS FOR THE T HANDLE BENT OUTWARDS AND THE THREAD OF THE CANNULATED CONNECTING PIN SNAPPED OFF IN THE LAG SCREW. THE IMPLANT WAS NOT ABLE TO BE REMOVED AS PLANNED. THIS REPORT IS FOR ONE (1) HELICAL BLADE COUPLING SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15612069 ↗
• MalfunctionFeb 26, 2021Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON THAT (B)(6), 2021 THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY. DURING THE SURGERY, THE HELICAL BLADE FOR TFN HAD THE SCREW THREAD DAMAGED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TFN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) HELICAL BLADE COUPLING SCREW. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388601 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A DEVICE INSPECTION, THE HELICAL BLADE COUPLING SCREW WAS FOUND BROKEN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HELICAL BLADE COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139904 ↗
• MalfunctionDec 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF THE INSTRUMENTATION, THE KNOB ON THE HELICAL BLADE COUPLING SCREW WAS BROKEN OFF THE SHAFT. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT INVOLVES 1 HELICAL BLADE COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11031634 ↗
• MalfunctionDec 16, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HELICAL COUPLING SCREW BROKE OFF IN HELICAL INSERTER DURING SURGERY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: HELICAL BLADE INSERTER (PART# 357.372, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR (1) HELICAL BLADE COUPLING SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023544 ↗
• MalfunctionNov 13, 2020Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE WHILE THE HELICAL BLADE WAS BEING IMPACTED, THE END OF THE COUPLING SCREW BEING USED BROKE OFF, AND HIT THE FLOOR. THE HELICAL BLADE WAS STILL MANAGED TO BE PUT IN POSITION. A WRENCH WAS USED TO DETACH THE COUPLING SCREW FROM THE BLADE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO MEDICAL INTERVENTION NEEDED. CONCOMITANT DEVICE REPORTED: HELICAL BLADE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1); IMPACTION INSTRUMENT (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A HELICAL BLADE COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10836835 ↗
• MalfunctionNov 10, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A PROXIMAL FEMUR OSTEOSYNTHESIS USING AN INTERTROCHANTERIC NAIL, AT THE TIME OF PLACING THE SPIRAL BLADE, THE SURGEON USED THE HAMMER FOR IMPACTIONS, WHICH CAUSED THE HEAD OF THE CONNECTING SCREW TO BREAK. THE SURGEON WAS UNABLE TO REMOVE THE SCREW FROM THE BLADE AND DECIDED TO REMOVE THE BLADE AGAIN BY HITTING THE INSERTION ARC. THE BLADE WAS REMOVED, AND THE PROCEDURE WAS CONTINUED. THE ARCH WIRE WAS ALREADY DAMAGED BY THE IMPACTIONS. THE DRILL GUIDE WAS PLACED FOR THE DISTAL LOCKING OF THE NAIL, AND THIS HOLE THROUGH, WHICH THE DRILL GUIDE SLEEVE PASSES IS NOT IN GOOD CONDITION. THE SLEEVE ENTERED THE HOLE AND THE DRILLING WAS MADE FOR THE DISTAL LOCKING OF THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN TFN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN HAMMER (PART # UNKNOWN LOT # UNKNOWN, QUANTITY 1), UNKNOWN TFN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN HAMMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) HELICAL BLADE C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10818080 ↗
• MalfunctionApr 10, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON WAS TIGHTENING THE HELICAL BLADE COUPLING SCREW TOO THE BLADE, THE END OF THE SCREW SNAPPED OFF AT THE SHOULDER. ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO IMPACT TO THE PATIENT. CONCOMITANT DEVICES REPORTED: NAIL HEAD ELEMENTS: TFN HELICAL BLADE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) HELICAL BLADE COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9949528 ↗
• InjuryMar 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 (2) DEVICES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9889864 ↗
• MalfunctionMar 24, 2020Break; Break

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A TROCHANTERIC FIXATION NAIL (TFN) INSERTION, THE TOP OF THE COUPLING SCREW BROKE OFF WHILE IT IS INSIDE THE INSERTER. IT WAS INCARCERATED AND THEY NEED TO REMOVE THE HELICAL BLADE AND OPEN A NEW SET IN ORDER TO INSERT A HELICAL BLADE INTO THE PATIENT. IT WAS BELIEVED THAT THE INSTRUMENTS WERE TOO OLD AND WELL USED. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: HELICAL BLADE (PART # 456.303, LOT # 23P4186, QUANTITY 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9874057 ↗
• MalfunctionFeb 3, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HELICAL BLADE COUPLING SCREW WAS RECEIVED BROKEN AFTER SURGERY. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9662198 ↗
• MalfunctionSep 19, 2019Break; Break

  IT WAS FURTHER REPORTED THAT DURING THE SURGERY ON (B)(6) 2019, THE SURGEON PLACED THE SPIRAL BLADE AND LOCKED THE PART OF THE INSTRUMENTS AND THEN THE SURGEON HAD TO REMOVE THE INSTRUMENTS BY PERFORMING DIFFERENT TECHNICAL MOVEMENTS, AT THAT TIME HELICAL BLADE COUPLING SCREW BROKE. THERE WERE FRAGMENTS GENERATED, HOWEVER THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THERE WAS SURGICAL DELAY OF FIFTEEN (15) MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9090491 ↗
• InjurySep 4, 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, THE DOCTOR ATTEMPTED TO REMOVE THE CONNECTING SCREW FROM THE HELICAL BLADE ONCE IMPLANTED IN THE PATIENT. THE CONNECTING SCREW WOULD NOT COME LOOSE, RESULTING IN USING AN UNKNOWN METHOD TO REMOVE IT. NO FURTHER DETAILS ON WHAT WAS USED, BUT IT RESULTED IN FAILURE OF THE PRODUCT. SURGICAL DELAY OF TWENTY (20) MINUTES WAS REPORTED. CONCOMITANT DEVICES: UNKNOWN TFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) HELICAL BLADE COUPLING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8960297 ↗
• MalfunctionAug 21, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, WHEN THE SURGEON WAS IMPACTING THE SPIRAL BLADE, THE CONNECTING SCREW FOR THE HELICAL BLADE BROKE. IT HAD TO BE BLOWN OUT AND PUT BACK IN FREEHAND, WHICH RESULTED IN PROLONGATION OF THE SURGICAL TIME BY FORTY (40) MINUTES. THE BROKEN PIECE WAS REMOVED. NO BACK UP SCREW WAS AVAILABLE TO USE. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE/S REPORTED: UNKNOWN HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY#1), UNKNOWN IMPACTOR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) HELICAL BLADE COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8916622 ↗
• InjuryApr 3, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE (TROCHANTERIC FIXATION NAIL) TFN HELICAL BLADE INSERTER ATTACHMENT SCREW BROKE WHILE INSERTING THE HELICAL BLADE. REPORTEDLY, NUT FELL OFF THE INSERTER CAUSING IT TO COME APART AND HAD TO MALLET IT TO GET IT DISCONNECTED FROM HELICAL BLADE. IT WAS NOTED ALSO THAT WHILE INSERTING THE HELICAL BLADE, THE END OF THE HELICAL BLADE COUPLING SCREW BROKE OFF LEAVING THE SHAFT IN THE INSERTER STILL ATTACHED TO THE HELICAL BLADE. THE HELICAL BLADE WAS SUCCESSFULLY INSERTED AND IT TOOK 20 MINUTES TO TAKE OFF THE INSERTER. FINALLY, THE BOLT CUTTERS WERE USED TO CUT THE SHAFT ABOVE WHERE IT WAS ATTACHED TO THE HELICAL BLADE. THE AIMING ARM WAS THEN ATTACHED BACK AND DISTALLY LOCKED TO FINISH THE CASE. WHILE MALLETING THE HELICAL BLADE, THE END OF THE COUPLING SCREW BROKE LEAVING THE SHAFT OF THE CONNECTING SCREW IN THE HELICAL BLADE INSERTER. THE FOLLOWING DEVICES WERE DAMAGED WHEN TRYING/ATTEMPTING TO REMOVE THE INSERTER: ONE (1) BUTTRESS/COMPRESSION NUT, ONE (1) BLADE GUIDE SLEEVE, AND ONE (1) AIMING ARM. THERE WERE FRAGMENTS GENERATED FROM A BROKEN DEVICE. THE FRAGMENTS WERE REMOVED EASILY WITHOUT ANY ADDITIONAL INTERVENTION. THERE WERE THIRTY (30) MIN

  Patient problems: Foreign Body In Patient

  MAUDE report 8479623 ↗
• 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 COUPLING SCREW. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8372172 ↗
• MalfunctionFeb 13, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INTRA-OPERATIVE SURGERY, THE TROCHANTERIC FIXATION NAIL SET WAS FOUND BROKEN. THIS INCLUDED THE HELICAL BLADE COUPLING SCREW, DEG AIMING ARM TROCHANTERIC FIXATION NAILS, AND HELICAL BLADE INSERTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HELICAL BLADE COUPLING SCREW THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8336476 ↗
• MalfunctionOct 22, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING REMOVAL OF A TROCHANTERIC FIXATION NAIL (TFN), THE HELICAL BLADE HAS BECOME STUCK ON THE CONNECTING SCREW AND EXTRACTION INSTRUMENT. THERE WAS NO INFORMATION GIVEN ON WHY THE IMPLANT WAS BEING REMOVED OR IF ANYTHING WAS IMPLANTED IN PLACE OF IT. THE CASE WAS ABLE TO CONTINUE AS THE BLADE HAD BEEN REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT WAS FINE AFTER THE SURGERY. THIS REPORT IS FOR ONE (1) HELICAL BLADE COUPLING SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7993307 ↗
• MalfunctionAug 14, 2018Break; Break

  (B)(6) REPORTS FOLLOWING: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM (TFN) PROCEDURE. DURING THE PROCEDURE, AFTER THE INSERTION OF THE HELICAL BLADE, THE HELICAL BLADE COUPLING SCREW HEAD SNAPPED OFF WHILE TRYING TO UNTHREAD FROM THE BLADE. THE COUPLING SCREW WAS LEFT ATTACHED TO THE HELICAL BLADE WITHIN THE HELICAL BLADE INSERTER AND COULD NOT BE REMOVED. THE SURGEON ATTEMPTED TO UNTHREAD THE SCREW BUT COULD NOT GET A SUFFICIENT HOLD AS THE SHAFT OF THE COUPLING SCREW WAS SUNKEN INTO THE IMPACTION HANDLE. THE TAPER OF THE COUPLING SCREW MADE IT IMPOSSIBLE TO REMOVE THE IMPACTION HANDLE TO UNTHREAD THE COUPLING SCREW. EVENTUALLY, THE SURGEON COULD ONLY BACK OFF THE COUPLING SCREW WITH MALLET STRIKES. WHILE SUCCESSFUL IN DISENGAGING THE COUPLING SCREW THIS LEFT THE HELIX BLADE IMPACTOR HEAVILY DAMAGED. THE PROCESS DELAYED SURGERY BY 40 MINUTES AND THERE WERE NO FURTHER COMPLICATIONS DURING THE SURGERY AND COMPLETED WITHOUT FURTHER INCIDENT. CONCOMITANT DEVICES REPORTED: HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), MALLET (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HELICAL BLADE COUPLIN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7781905 ↗
• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE, THE TIP OF THE HELICAL BLADE COUPLING SCREW BROKE INTO THE HELICAL BLADE AS THE HELICAL BLADE WAS ADVANCED TO THE FINAL POSITION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. CONCOMITANT DEVICES REPORTED: HELICAL BLADE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), HELICAL BLADE INSERTER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7762637 ↗
• MalfunctionMay 15, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTED THE HELICAL BLADE COUPLING SCREW END CAP BROKE INTO TWO PIECES UPON INSERTING THE HELICAL BLADE WITH REGULAR HAMMER BLOWS. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE: HAMMER (PART/LOT UNKNOWN, QUANTITY 1); HELICAL BLADE (PART/LOT UNKNOWN, QUANTITY 1) THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7516008 ↗
• MalfunctionMay 14, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURE WITH TROCHANTERIC FIXATION NAIL (TFN) ON (B)(6) 2018. DURING THE PROCEDURE, THE HELICAL BLADE COUPLING SCREW WAS BROKEN INTO TWO SEPARATE PIECES WHILE USING THE HELICAL BLADE INSERTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE FIVE (5) MINUTES SURGICAL DELAY REPORTED. THE PATIENT OUTCOME REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: HELICAL BLADE IMPACTOR (PART #: 357.372, LOT UNKNOWN, QUANTITY 1), UNKNOWN NAIL ( PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), HELICAL BLADE ( PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HELICAL BLADE COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7510901 ↗
• MalfunctionMay 8, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL (TFN) INTRAMEDULLARY NAILING PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE, WHILE THE SURGEON WAS INSERTING THE HELICAL BLADE WITH A MALLET, THE END OF THE COUPLING SCREW BROKE OFF COMPLETELY AND LANDED ON THE FLOOR. THE SURGEON WAS ABLE TO REMOVE THE SHAFT OF THE COUPLING SCREW FROM THE HELICAL BLADE INSERTER USING AN EXTRACTION SCREW. THERE WAS A 10 MINUTES SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE AND SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN HELICAL BLADE INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN TFN HAMMER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7496650 ↗
• MalfunctionApr 17, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT SURGERY AN INITIAL TROCHANTERIC FIXATION NAIL. INTRAOPERATIVE DURING THE IMPLANTATION OF AN UNKNOWN HELICAL BLADE INTO THE PATIENT, THE PROXIMAL END OF BOTH THE HELICAL BLADE INSERTER AND HELICAL BLADE COUPLING SCREW BROKE OFF. THE BROKEN PIECES FROM BOTH DEVICES BROKE OFF AT THE SAME TIME AND FELL ONTO THE FLOOR. THERE WERE NO FRAGMENTS FROM EITHER DEVICE THAT FELL INTO THE PATIENT. THE SURGEON ATTACHED A UNIVERSAL CHUCK WITH T-HANDLE TO THE REMAINING PORTION OF THE COUPLING SCREW TO FINISH IMPLANTING THE HELICAL BLADE. THE ENTIRE HELICAL BLADE WAS FULLY IMPLANTED INTO THE PATIENT. THERE WAS NO MALFUNCTION WITH THE HELICAL BLADE OR UNIVERSAL CHUCK WITH T-HANDLE. THERE WAS ABOUT A FEW MINUTES DELAY IN THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH ONLY A FEW MINUTES DELAY IN SURGERY. THERE WAS NO PATIENT HARM. THE PATIENT REMAINED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: UNIVERSAL CHUCK WITH T-HANDLE (PART# 393.10, LOT# UNKNOWN, QUANTITY 1) ; NAIL HEAD ELEM- TFN HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) ; IMPACTION INST: HAMMER/MALLET- TR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) ; THIS REPO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7437608 ↗
• MalfunctionMar 30, 2018Break; Break

  IT WAS REPORTED THAT A HELICAL BLADE COUPLING SCREW IS BROKEN. THIS WAS DISCOVERED IN STERILE PROCESSING. NO PATIENT AND PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7386755 ↗