NA 03.008.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886982066886), received between Jun 21, 2017 and Sep 15, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT THE AIMING ARM WAS BROKEN. BOTH THE AIMING ARM AND THE PIN THAT GOES IN THE AMASSING ARM WERE DAMAGED. THERE WERE NO PATIENT ISSUES. ISSUE WAS NOTED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051295 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN PERFORMING THE PROXIMAL LOCKING, THE ARCH WAS OUT OF CALIBRATION, WHICH IS WHY THE SPECIALIST DECIDED TO LOCK BY FREEHAND AND THE BIT WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650107 ↗
• MalfunctionJan 23, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT DURING EXAMINATION AT MANUFACTURER OFFICES ON AN UNKNOWN DATE, THE HINDFOOT NAIL AIMING ARM APPEARED TO BE DAMAGED AND WILL NOT ACCEPT A TROCAR THROUGH THE AIMING. THIS PRODUCT WAS NOT BEING USED IN A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218594 ↗
• MalfunctionNov 4, 2024Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE AIMING ARM MISSED PROXIMAL LOCKING SCREWS. THE AIMING ARM CONSTRUCT SEEMS TO LOOSE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598751 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JULY 26, 2024, THE TARGETING HOLES WERE NOT LINING UP WITH THE NAIL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044258 ↗
• MalfunctionNov 14, 2023Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE AIMING ARM FOR TITANIUM CANNULATED HINDFOOT ARTHRODESIS NAIL HAS A NOTCH IN ONE OF THE SLUT FOR A 12/8 MM PROTECTION SLEEVE. WE ARE NOT ABLE TO INSERT SCREWS IN THAT SLOT BECAUSE OF THAT NOTCH. NEED REPLACEMENT OF ARM. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) AIM ARM FOR TI CANN HINDFOOT ARTHRO NL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130763 ↗
• MalfunctionSep 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17788410 ↗
• MalfunctionMay 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE NETHERLANDS REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, A SCREW DID NOT ALIGN PROPERLY. AS A RESULT, IT WAS HIT AND DAMAGED DURING DRILLING. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX.. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992023 ↗
• MalfunctionJan 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREW MISSED SEVERAL TIMES IN THE TALUS THROUGH THE AIMING ARM OF THE HAN NAIL. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES AND A SURGICAL DELAY OF 60 MINS OCCURRED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) AIM ARM FOR TI CANN HINDFOOT ARTHRO NL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16186285 ↗
• MalfunctionNov 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, UPON ROUTINE INSPECTION PRIOR TO THE CASE, THE SALES CONSULTANT WAS ASSEMBLING THE AIMING ARM WHEN THE THREADED ALIGNMENT PIN BECAME STUCK IN THE AIMING ARM. ALL ATTEMPTS TO SEPARATE THEM WAS UNSUCCESSFUL. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762173 ↗
• MalfunctionSep 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SURGERY THE AIMING ARM FOR THE HIND FOOT NAIL MISSED ALL PROXIMAL LOCKING SCREWS. THERE WAS NO FRAGMENTS GENERATED BECAUSE SURGEON DID PERFECT CIRCLES FOR PROXIMAL SCREW. THERE WAS A SURGICAL DELAY OF 20 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 2 OF 2 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15405543 ↗
• MalfunctionMar 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED DURING THE PROCEDURE AT THE TIME OF LOCKING THE MOST PROXIMAL SCREW THE NAIL WAS HIT BY THE DRILL BIT. THERE WAS NO PATIENT HARM; THE NAIL WAS BLOCKED USING A FREEHAND TECHNIQUE. THE SURGICAL TIME WAS NOT EXTENDED. THIS REPORT IS FOR AN AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13829542 ↗
• MalfunctionJan 26, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, INTRAOPERATIVELY THE AIMING ARM COULD NOT BE USED CORRECTLY, THE AIM WAS INACCURATE. THREE BOLTS SHOULD BE PLACED DURING THE ANKLE JOINT SURGERY BUT ONLY ONE COULD BE PLACED DUE TO THE ALLEGATION OF THE INSTRUMENT. PROCEDURE WAS DELAYED FOR SIXTY(60) MINUTES. THIS REPORT IS FOR ONE (1) AIM-ARM F/EXPERT HAN F/03.008.007. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358961 ↗
• MalfunctionMar 16, 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 CONNECTION SCREW WOULD NOT CONNECT TO THE EXPERT HINDFOOT ARTHRODESIS NAIL (HAN) AND THE AIMING ARM PROPERLY. WHEN ATTEMPTING TO LOCK THE SCREW, THE AIMING ARM DISCONNECTS FROM THE SCREW. THE SCREW ONLY SCREWS ON WITH ONE TURN AND THEN STOPS. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT INVOLVES ONE (1) AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495043 ↗
• MalfunctionDec 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HINDFOOT ARTHRODESIS NAIL SET - UNDERWENT TRAY AUDIT AND PREVENTATIVE MAINTENANCE. THE INSTRUMENTS REQUIRE REPLACEMENT AS THE ENTIRE AIMING ARM SEEMS TO BE MISSING THE NAIL DURING DRILLING/SCREW INSERTION. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101743 ↗
• InjuryAug 6, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF ABOUT TWENTY (20) MINUTES.

  Patient problems: Injury; No Code Available

  MAUDE report 10373833 ↗
• MalfunctionFeb 26, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 DURING A REMOVAL OF A BROKEN NAIL AND REVISION FUSION LEFT TIBIO-TALO-CALCANEAL FUSION WITH BONE GRAFT, THAT A PATIENT ON FOLLOW UP OF PREVIOUS PROCEDURE FOUND TO HAVE BROKEN PREVIOUSLY IMPLANTED TORNIER / WRIGHT MEDICAL 611 NAIL (12MM X 180MM). BREAKAGE ABOVE THE PROXIMAL CALCANEAL SCREW. REVISION BOOKED, WITH CONSULTANT REQUESTING DPS NAIL REMOVAL, RIA AND HAN, AS WELL AS WRIGHT 611 REMOVAL SET. BROKEN NAIL EXTRACTED, WITH DIFFICULTY REMOVING PROXIMAL END OF THE BROKEN NAIL. WINDOW IN PATIENT TIBIA CREATED IN ORDER TO ASSIST WITH REMOVAL. SURGEON SELECTED HAN 13MM X 240MM LEFT NAIL, WHICH WAS CHECKED, PRIOR TO BEING ASSEMBLED ONTO AIMING DEVICE. ALIGNMENT TEST COMPLETE PRIOR TO NAIL INSERTION IN LINE WITH THE SURGICAL TECHNIQUE WITH NO FAULTS NOTED. ON INSERTION OF THE NAIL, THE SURGEON AGAIN VERIFIED NAIL IN CORRECT ALIGNMENT VIA INTRA OP X-RAY AND CONFIRMED NAIL TO BE LOCKED INTO POSITION. SURGEON ELECTED TO USE TWO DISTAL LOCKING SCREWS THROUGH NAIL AS INDICATED, HOWEVER ON PLACING PROTECTION SLEEVE IN MOST DISTAL LOCKING SCREW POSITION, AND DRILLING, FOUND THE DRILL TO BE HITTING

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9756304 ↗
• InjurySep 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A LEFT HINDFOOT ARTHRODESIS WITH NAIL PROCEDURE ON (B)(6) 2019, THE AIMING ARM ASSEMBLY MISALIGNED BOTH PROXIMAL SCREWS. THE SURGEON INSERTED A LEFT EXPERT HINDFOOT NAIL. IT WAS CONFIRMED THE NAIL WAS LOADED PROPERLY ONTO INSERTION HANDLE BY CONFIRMING THE BEND OF THE NAIL MATCHED THE ETCHED PICTURE ON THE INSERTION HANDLE. THE SURGEON ALSO TESTED THE AIMING ARM BEFORE INSERTION INTO PATIENT BY PUTTING THE TRIPLE TROCAR ASSEMBLY AND CORRESPONDING DRILL BIT THROUGH THE CORRESPONDING NAIL HOLES. WITH THE NAIL INSERTED AND THE AIMING ARM IN (P) POSITION, THE SURGEON INSERTED TWO (2) 6.0 MM SCREWS INTO THE CALCANEUS WITHOUT ISSUE. HE ALSO DRILLED AND INSERTED THE OBLIQUE 5.0 MM SCREW INTO THE TALUS WITHOUT ISSUE. WHEN THE SURGEON TRIED TO DRILL THROUGH THE (TWO) 2 (CORRECT) PROXIMAL HOLES LABELLED (STATIC) AND (180) THE 4.2 MM DRILL BIT ENCOUNTERED THE NAIL ITSELF AND COULD NOT PASS THROUGH THE DESIGNATED NAIL HOLES. FOR THESE PROXIMAL SCREWS THE AIMING ARM SHOWED (M) IN THE WINDOW AS APPROPRIATE AND HE USED TRIPLE TROCAR ASSEMBLY WITH DRILL BIT, WHICH WERE THE SAME ITEMS HE HAD USED FOR THE TALAR

  Patient problems: Injury; No Code Available

  MAUDE report 9118370 ↗
• MalfunctionOct 25, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INSPECTION OF THE DEVICES ON OCTOBER 11, 2018, IT WAS NOTED THAT THE AIMING ARM DID NOT LINE UP WITH THE HOLES OF THE NAIL WHEN ATTEMPTING TO INSERT THE PROXIMAL LOCKING SCREWS INTO THE NAIL. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. CONCOMITANT MEDICAL PRODUCTS: LOCKING SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8007484 ↗
• MalfunctionSep 7, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING PREPARATION FOR LOCKING WITH THE PROXIMAL SCREW, THE DRILL BIT DIDN¿T HIT THE HOLE PROPERLY. THERE WAS NO PATIENT HARM AND THE SURGERY WAS PROLONGED FOR APPROXIMATELY 10 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7855708 ↗
• MalfunctionJul 9, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HINDFOOT NAIL ARTHRODESIS CASE AND FOOT SURGERY ON (B)(6) 2018. DURING THE PROCEDURE, THE AIMING ARM AND INSERTION HANDLE WERE BEING USED IN THE HINDFOOT FUSION CASE, AND THE AIMING ARM AND INSERTION HANDLE MISSED THE PROXIMAL LOCKING HOLES IN THE NAIL DURING PROXIMAL LOCKING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR AN AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7671134 ↗
• MalfunctionMay 11, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HINDFOOT FUSION SURGERY ON (B)(6) 2018. THE SURGEON WAS USING A SYNTHES HINDFOOT NAIL. DURING THE SURGERY, THE DRILL BIT SLEEVE TURNED OUT TO BE STUCK IN THE TARGETING DEVICE WHILE DRILLING FOR THE LOCKING SCREWS. SINCE THE SURGEON EXERTED SOME FORCE, THE STUCK SLEEVE WAS REMOVED AND THE SURGERY PROCEEDED AS SCHEDULED. IT WAS ALSO REPORTED THAT THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE PATIENT OUTCOME WAS NOT REPORTED. THERE IS NO OTHER INFORMATION AVAILABLE AT THIS TIME. DURING MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE SLEEVE WAS UNABLE TO FULLY PASS THROUGH THE LOCKING HOLE DUE TO THE DAMAGE. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. CONCOMITANT DEVICE/S REPORTED: UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY UNKNOWN). THIS REPORT IS FOR ONE (1) AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7508716 ↗
• MalfunctionNov 29, 2017Failure to Align; Failure to Align

  IT WAS REPORTED DURING AN ANKLE FUSION PROCEDURE FOR A LEFT HINDFOOT ARTHRODESIS ON (B)(6) 2017, THE SURGEON ATTEMPTED TO INSERT TWO DRILL BITS VIA 2 DIFFERENT HOLES OF THE AIMING ARM AND THEY KEPT HITTING THE NAIL. THEY SEEMED TO BE MISALIGNED WITH THE AIMING ARM OR THE INSERTION HANDLE, BUT THE SURGEON FELT HE HAD ENOUGH ROOM AND WAS ABLE TO CREATE THE HOLE FOR THE SCREWS. THIS HAPPENED IN SEVERAL SCREW HOLES. UPON SCREW INSERTION, SURGEON WAS ABLE TO MANIPULATE THE DRILL TO GET THE SCREWS IN THE HOLES SUCCESSFULLY. THERE WAS A TWO MINUTES DELAY JUST TO REALIGN THE DRILL. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO MEDICAL INTERVENTION REQUIRED. PATIENT STATUS FOLLOWING SURGERY WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), TROCAR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), CANNULATED CONNECTING SCREW (PART# 03.010.146, LOT# U225004, QUANTITY 1), THREADED ALIGNMENT PIN (PART# 03.008.004, LOT# 1733002, QUANTITY 1), PROTECTION SLEEVE (PART# 03.010.063, LOT# 1939259, QUANTITY 1), DRILL SLEEVE (PART# 03.010.065, LOT# 1593330, QUANTITY 1), DRILL SLEEVE (PART# 03.010.066, LOT# 3436603, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068316 ↗
• MalfunctionAug 28, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT AN INSERTION HANDLE, AIMING ARM AND CANNULATED CONNECTING SCREW FOR PERCUTANEOUS INSERTION HANDLE WERE INSTRUMENTAL IN A SCREW NOT ALIGNING WITH A NAIL ON (B)(6) 2017. THIS MISALIGNMENT OCCURRED DURING A HINDFOOT FUSION PROCEDURE LEADING TO A MINUTE SURGICAL DELAY. AN X-RAY (UNAVAILABLE) WAS TAKEN DUE TO THE MISALIGNMENT. ANOTHER SET OF INSTRUMENTS WAS READILY AVAILABLE AND PROCEDURE WAS SUCCESSFUL WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT IS FOR THREE (3) DEVICES. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1); UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1). THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6825749 ↗
• MalfunctionJul 24, 2017Difficult To Position; Difficult To Position

  IT WAS REPORTED THAT AN AIMING ARM WASN'T LINING UP WITH THE PROXIMAL HOLES ON A NAIL FROM A HINDFOOT SET. THIS WAS NOTICED DURING AN IN-SERVICE FOR A SURGEON AT A FACILITY. THERE IS NO PROCEDURE OR PATIENT INVOLVEMENT WITH THIS COMPLAINT. CONCOMITANT DEVICES REPORTED: PART NUMBER 03.008.004 / LOT NUMBER 1501807(THREADED ALIGNMENT PIN), QUANTITY X 1, PART NUMBER 03.008.004 / LOT NUMBER 1435078 (THREADED ALIGNMENT PIN), QUANTITY X 1, PART NUMBER 03.008.007 / LOT NUMBER 1435081 (INSERTION HANDLE), QUANTITY X 1. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6736618 ↗