NA 03.010.051Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982067234), received between Jun 21, 2018 and Jun 12, 2023 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADED PORTION OF THE AIMING ARM IS DAMAGED AND DOES NOT ALLOW A PROPER CONNECTION BETWEEN THE AIMING ARM AND INSERTION HANDLE. THE THREADS ON BOTH ITEMS ARE DAMAGED. THIS WAS DISCOVERED ON (B)(6) 2023 IN STERILE PROCESSING DEPARTMENT (SPD) AFTER A CASE PERFORMED AT MEDICAL CENTER. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17104679 ↗
• MalfunctionApr 19, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A AIM-ARM F/EXPERT R/AFN RETROGR F/SPIRAL IT WAS OBSERVED THAT VISIBLE DAMAGE IS DEFORMATION. DEVICE WAS RECEIVED AT WEST CHESTER TODAY. THERE WAS NO PATIENT AND HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES (1) DEVICES AIM-ARM F/EXPERT R/AFN RETROGR F/SPIRAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140644 ↗
• 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) AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421786 ↗
• MalfunctionApr 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 WHILE DRILLING FOR THE DISTAL SCREW OF A RETROGRADE/ANTEGRADE FEMORAL NAIL, THROUGH THE SPIRAL BLADE ATTACHMENT, THE DRILL BIT AND SCREW BOTH SKIVED POSTERIORLY MISSING THE NAIL ALL TOGETHER. THE SCREW WAS ABORTED AND THE SPIRAL BLADE WAS COMPLETED WITHOUT INCIDENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725425 ↗
• MalfunctionFeb 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE QUICK CONNECT ATTACHMENT DID NOT WORK WITH QC ADAPTERS. THERE WAS NO REPORTED SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES 1 AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366880 ↗
• MalfunctionDec 7, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, THE AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING SEEMS THERE IS A SLIGHT LITTLE BIT A DENT INSIDE THAT SLEEVE WHICH PREVENTING THE UNKNOWN SLEEVE TO GO THROUGH OR ANYTHING SO. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT WAS AFFECTING. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960679 ↗
• 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) AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING. THIS IS REPORT 2 OF 3 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10524413 ↗
• 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 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9850559 ↗
• 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 STUCKED 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 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8700218 ↗
• MalfunctionJun 10, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED ON (B)(6) 2019, THE AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING IS BROKEN AND NOT CALIBRATED CORRECTLY. IT WAS MENTIONED THAT IT IS PROBABLY BENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8683234 ↗
• 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) AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8277838 ↗
• 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) AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7940232 ↗
• 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 AN AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7819940 ↗
• 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. THE AIMING ARM SHOWS SIGNS OF MINIMAL WEAR AND IT HAS CORROSION STAINS ON THE ETCHED REGION. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS REPORT IS FOR ONE (1) AIM-ARM F/EXPERT R/AFN RETROGR F/SPIRAL. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7739586 ↗
• InjuryJun 21, 2018Mechanical Jam; Mechanical Jam

  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 WAS ALSO NOTED, THE SPIRAL BLADE INSERTER "STICKS" WHEN PASSING THE BLADE THROUGH THE AIMING ARM ADAPTER. THE 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. IT IS NOT KNOWN IF SURGERY WAS DELAYED DUE TO THIS ISSUE. PATIENT STATUS IS NOT KNOWN. WHILE THE RETURNED DEVICES WERE BEING INSPECTED BY THE MANUFACTURER, IT WAS NOTED THAT THE DEVICES ARE STICKING TOGETHER AND FEW NICKED PORTIONS WERE OBSERVED ON THE ADAPTER MATING EDGES. IT WAS DETERMINED THAT THE PREVIOUSLY REPORTED CONCOMITANT AIMING ARM ADAPTER SHOULD BE ADDED AS A COMPLAINED DEVICE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7624829 ↗