NA 03.010.084Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982067548), received between Sep 20, 2017 and Apr 25, 2022 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A HIND FOOT NAIL ORTHOPEDIC SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SPIRAL BLADE DEVICE COULD NOT GET THE BLADE INSERTER THROUGH THE AIMING ARM ADAPTER DEVICE. IT WAS REPORTED THAT THE SURGEON ATTEMPTED THIS A COUPLE OF TIMES BUT HAD TO GO TO THE SPIRAL BLADE EXTRACTION TOOL TO INSERT THE BLADE. ACCORDING TO THE REPORT, THE SURGEON ATTEMPTED TO GET THE INSERTER THROUGH THE AIMING ADAPTER BUT STILL WOULD NOT GO THROUGH. IT WAS REPORTED THAT THE REPORTER CLAIMED THAT IT LOOKED LIKE THAT THE INSERTER HAD A BIGGER DIAMETER THAN THE HOLE OF THE ADAPTER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) SPIRAL INSERTER F/SPIRAL BLADE INSERT F/ DEVICE. THIS COMPLAINT INVOLVES 3 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192953 ↗
• MalfunctionSep 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2021, DURING THE RETROGRADE FEMORAL NAIL SURGICAL CASE, THE SURGEON USED A SPIRAL INSERTER FOR SPIRAL BLADE INSERTION FOR ADDITIONAL FIXATION. HE INSERTED AN 80MM SPIRAL BLADE INTO PROPER DEPTH WITHOUT ANY DIFFICULTY AND UNSCREWED THE UNKNOWN CONNECTING SCREW FOR INSERTER FOR TITANIUM SPIRAL BLADES. WHEN HE ATTEMPTED TO PULL THE SPIRAL BLADE INSERTER OUT OF THE AIMING ARM FOR RETROGRADE SPIRAL BLADE, THE SPIRAL BLADE INSERTER WAS STUCK INSIDE THE AIMING ARM. THE SURGEON WAS ABLE TO REMOVE THE AIMING ARM FOR SPIRAL BLADE INSERTER FROM THE UNKNOWN NAIL INSERTER. HE COMPLETED THE REST OF THE CASE WITHOUT ANY PROBLEMS. AFTER THE CASE WAS COMPLETED AND THE INSTRUMENTS WERE DECONTAMINATED I WAS ABLE TO SEPARATE ITEMS HOWEVER THE INSERTER NO LONGER MOVES FREELY THROUGH THE AIMING ARE AND NEEDS TO BE REPLACED. NO FRAGMENT GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421784 ↗
• MalfunctionAug 26, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE THE SPIRAL BLADE INSERTER FOR THE RETROGRADE NAIL WAS FOUND TO BE BROKEN AND WORN. THE INSERTER NUT WOULD NOT RETAIN THE INSERTER. THIS REPORT INVOLVES (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371446 ↗
• MalfunctionSep 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SPIRAL BLADE INSERTER WOULD NOT PROPERLY HOLD THE SPIRAL BLADE AND WAS DIFFICULT TO REMOVE FROM SPIRAL BLADE AIMING ARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED . THE SPIRAL BLADE WAS SUCCESSFULLY IMPLANTED. THERE WAS NO DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SPIRAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX THIS IS REPORT 1 OF 3 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10524433 ↗
• MalfunctionJun 1, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING RETROGRADE FEMUR NAIL INSERTION PROCEDURE ON MAY 18, 2020, THE SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAIL WAS BROKEN, AND THE CONNECTING SCREW FOR INSERTER FOR TI SPIRAL BLADES GOT STUCK SO THE BLADE OF THE INSTRUMENT COULDN'T BE TURNED. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: CONNECTING SCREW FOR INSERTER FOR TI SPIRAL BLADES (PART# 357.340, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10105683 ↗
• MalfunctionMar 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, AN AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING AND SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAIL WERE JAMMED DURING AN UNKNOWN PROCEDURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO INCIDENT TO THE PATIENT. THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9850554 ↗
• MalfunctionJan 28, 2020Break; Break

  LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2019, A SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAIL WAS NOTED TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT (B)(6). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9639724 ↗
• MalfunctionNov 22, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ANTEGRADE FEMUR RECON NAIL, WHILE IMPLANTING AN UNKNOWN FEMORAL RECON NAIL (FRN) WITH HAMMER THAT BLOWS TO THE THREADED DRIVING CAP, THE TIP OF THE CAP BROKE OFF IN THE RECESS OF THE INSERTION HANDLE. THE RESIDENT TIGHTENED THE DRIVING CAP BEFORE THIS HAPPENED. BECAUSE OF POOR REDUCTION AND NO WAY TO BACK SLAP THE NAIL OUT THE SURGEON DECIDE TO TAKE OFF THE INSERTION HANDLE AND USE THE EXTRACTOR. NAIL WAS REMOVED SUCCESSFULLY. HE DECIDED IT WAS BEST TO CONVERT TO A RETROGRADE NAIL. WHICH WAS PERFORMED WITHOUT ANY ISSUES UNTIL THEY WENT TO INSERT THE SPIRAL BLADE AND THE INSERTION HANDLE WAS BROKEN AT THE TIP. THE SURGEON FELT IT WOULD WORK AND THE PROCEDURE WAS COMPLETED WITHOUT ANYMORE DISRUPTIONS. THERE WAS SURGICAL DELAY OF FIVE TO TEN (5-10) MINUTES. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN FEMORAL RECON NAIL (PART # 04.033.069S, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN HAMMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS 3 OF 3 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9364188 ↗
• MalfunctionJun 14, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN INTRAMEDULLARY NAIL OF A FEMUR, THEY WERE DOING A RETROGRADE FEMORAL NAIL ON A PATIENT. THE PRONG FROM THE SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EXPERT BROKE OFF AS THE SPIRAL BLADE BEING INSERTED. THE SPIRAL BLADE WAS INSERTED FINE, BUT, WHEN THEY TRY TO REMOVE, THE SPIRAL BLADE INSERTER FROM THE PATIENT WAS STUCK IN THE AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING. THEY JUST HAD IT REMOVED THE WHOLE HANDLE AND AS FAR AS THE IMPLANT IN THE PATIENT EVERYTHING WAS FINE. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO BACK UP WAS AVAILABLE. THE PATIENT WAS RECOVERING FINE. CONCOMITANT DEVICE REPORTED: UNK - NAILS: FEMORAL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8700270 ↗
• MalfunctionMay 30, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING KNEE SURGERY, THE TIP OF THE IMPACTOR BROKE. THE SURGEON MISSED THE IMPACTOR WHILE USING A MALLET. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO ADVERSE EVENTS OCCURRED AND NO DELAY TO CASE. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN MALLET (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8654229 ↗
• MalfunctionMay 13, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INSPECTION AT THE STERILE PROCESSING DEPARTMENT A SPIRAL INSERTER FOR SPIRAL BLADE INSERTION IN AN UNKNOWN ORTHOKIT MODULE WAS FOUND DIRTY INSIDE THE CANNULATION. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8606100 ↗
• MalfunctionJan 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE THE TECHNICIAN WAS CLEANING DURING A ROUTINE INSPECTION IN THE STERILE PROCESSING DEPARTMENT (SPD), THE SPIRAL BLADE INSERTER HAD GONE THROUGH THE AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING AS HE PUSHED IT IN, IT GOT STUCK AND TECHNICIAN CANNOT PULL IT OUT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8277839 ↗
• MalfunctionOct 5, 2018Corroded; Device-Device Incompatibility; Corroded; Device-Device Incompatibility

  IT WAS REPORTED THAT AT THE END OF AN UNKNOWN PROCEDURE CARRIED OUT ON (B)(6) 2018, ONE (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX AND ONE (1) AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING WERE NOT WORKING AS THE INSERTER WAS REPORTED TO HAVE BEEN STUCK ON THE AIMING ARM AFTER THE PROCEDURE WAS COMPLETED. THE SURGEON COULDN'T REMOVE THE INSTRUMENTS OFF OF EACH OTHER, BUT SUCCESSFULLY DISCONNECTED THEM OFF THE MAIN INSERTION HANDLE. THERE WAS NO PROBLEMS DURING THE PROCEDURE AND THE PROCEDURE OUTCOME WAS REPORTED TO BE FINE. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7940324 ↗
• MalfunctionAug 27, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018 AT THE STERILE PROCESSING DEPARTMENT, THE SPIRAL BLADE INSERTER AND THE SPIRAL BLADE AIMING ARM WOULD NOT COME APART. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7819878 ↗
• MalfunctionAug 1, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DEVICES WERE EXPERIENCING ISSUES EITHER BROKEN OR NOT PERFORMING AS THEY SHOULD. A DEPTH GAUGE BROKE, AND A SPIRAL BLADE INSERTER WAS STUCK IN THE AIMING ARM. ALL DEVICE MALFUNCTIONS WERE FOUND IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT AND PROCEDURE INVOLVED. UPON RECEIPT OF THE DEVICE IT WAS IDENTIFIED THAT THE INSERTER COULD NOT BE ADVANCED OR RETRACTED FROM THE RECEIVED POSITION IN THE AIMING ARM. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7739631 ↗
• InjuryMay 14, 2018Break; Break

  IT WAS REPORTED PATIENT UNDERWENT A HINDFOOT ARTHRODESIS PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE, SURGEON OPTED TO USE THE SPIRAL BLADE INSERTER FOR RETROGRADE/ANTEGRADE FEMORAL NAILS (RAFN) FOR INSERTION OF THE SPIRAL BLADE RATHER THAN THE MIDFOOT/HINDFOOT SPIRAL BLADE INSERTER. DURING SPIRAL BLADE INSERTION, THE SPIRAL BLADE INSERTER FOR RAFN BROKE. THE SPIRAL BLADE WAS REMOVED AND THEN REINSERTED AFTER ADDITIONAL DRILLING OF THE ENTRY SITE IN THE CALCANEUS. IT IS NOT KNOWN IF SURGERY WAS DELAYED DUE TO THIS ISSUE. PATIENT STATUS IS NOT KNOWN THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR RETROGRADE/ANTEGRADE FEMORAL NAILS EX THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7511846 ↗
• MalfunctionSep 20, 2017Break; Break

  IT WAS REPORTED THAT THE SPIN PIECE OF THE SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX DEVICE BROKE OFF CLEANLY FROM THE BACK END OF THE DEVICE. THAT BROKEN PIECE IS MISSING AND CANNOT BE FOUND. THIS DEVICE WAS DISCOVERED IN THE CENTRALIZED PROCESSING DEPARTMENT. THIS MAY HAVE OCCURRED DURING THE CLEANING PROCESS IN THE CENTRALIZED PROCESSING DEPARTMENT. THERE WERE NO OTHER FRAGMENTED PIECES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6880596 ↗