NA 03.010.047Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10886982067197), received between Jan 13, 2019 and Apr 29, 2025 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (33 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCT WAS UNABLE TO BE STERILIZED/ASSEMBLED. THERE WAS CHIPPING AND CRACKING. PRODUCT IS UNABLE TO BE USED.

  Patient problems: Insufficient Information

  MAUDE report 21929571 ↗
• MalfunctionApr 29, 2025Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCT WAS UNABLE TO BE STERILIZED/ASSEMBLED. THERE WAS CHIPPING AND CRACKING. PRODUCT IS UNABLE TO BE USED.

  Patient problems: Insufficient Information

  MAUDE report 21929570 ↗
• MalfunctionApr 29, 2025Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCT WAS UNABLE TO BE STERILIZED/ASSEMBLED. THERE WAS CHIPPING AND CRACKING. PRODUCT IS UNABLE TO BE USED.

  Patient problems: Insufficient Information

  MAUDE report 21929568 ↗
• MalfunctionApr 29, 2025Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCT WAS UNABLE TO BE STERILIZED/ASSEMBLED. THERE WAS CHIPPING AND CRACKING. PRODUCT IS UNABLE TO BE USED.

  Patient problems: Insufficient Information

  MAUDE report 21929566 ↗
• MalfunctionMar 10, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TRAY FOUND IN SPD WITH THE HANDLE ATTACHMENT BROKEN OFF SO IT WILL NOT STAY ON INSERTION HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560885 ↗
• MalfunctionMar 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THERE WAS A DEFECT WITH THE IN THE LFN (LATERAL FEMORAL NAIL) EXPERT INSTRUMENTS. THE INTERNAL THREAD OF THE RECOIL ADAPTOR OR THREAD OF THE RECOIL DOME ON THE LEFT-HAND SIDE DOES NOT CORRESPOND CORRECTLY. THE DRILL SLEEVE FOR THE PROXIMAL LOCKING SCREW APPEARS TO HAVE A DEGREE, WHICH MEANS THAT IT CAN NO LONGER BE PUSHED CORRECTLY THROUGH THE INSERTION HANDLE ONTO THE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE GOOD. THIS REPORT INVOLVES ONE UNK: GUIDES,SLEEVES, AIMING. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826473 ↗
• MalfunctionAug 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE CONNECTOR FOR INSERTION HANDLE WASN¿T ABLE TO BE REMOVED FROM THE INSERTION HANDLE. NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT. THIS REPORT IS FOR ONE (1) CONNEC L141 F/INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650467 ↗
• MalfunctionJun 1, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 17-MAY-2023 DURING LOAN KIT INSPECTION, THE THREAD ON THE CONNECTION HANDLE IN QUESTION WAS FOUND TO HAVE WORN. IT IS UNABLE TO CONNECT TO OTHER COMPONENTS AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT, NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17041604 ↗
• MalfunctionMay 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVING CAP WAS STUCK ON THE INSERTION HANDLE (ADOLESCENT NAIL INSERTION HANDLE). IT WAS DISCOVERED WHILE RETRIEVING THE SET FROM STORAGE. THERE WAS NO PATIENT INVOLVED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950047 ↗
• MalfunctionMar 22, 2023Break; Device-Device Incompatibility; Material Twisted/Bent; Break; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, INTRA-OPERATIVELY THE INSERTION HANDLE & CONNECTOR SCREW CROSS THREADED. THE SURGEON TRIED TO UNDO THE CONNECTING SCREW USING THE COMBINATION WRENCH AND PIN WRENCH; THE ITEMS GOT STUCK AND BROKE. NO PATIENT INVOLVEMENT. THE EVENT OCCURRED INTRA-OP AND POST-OP, UNDOING THE INSERTION HANDLE AND CONNECTOR SCREW. THIS REPORT IS FOR ONE (1) DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592684 ↗
• MalfunctionMar 10, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THERE WERE MANY INCONVENIENCES IN SURGERY BECAUSE THE DEVICE HAD A DAMAGED SCREW, AND IT COULD NOT BE SCREWED INTO THE INSERTION HANDLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522235 ↗
• MalfunctionOct 3, 2022Device Slipped; Device-Device Incompatibility; Material Twisted/Bent; Device Slipped; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DATE, THE INSTRUMENT¿S TWO PARTS COULD NOT BE ASSEMBLED, THEREFORE IT WAS NOT POSSIBLE TO MOUNT ON INSTRUMENT HANDLE PROPERLY. THE INSTRUMENT WAS LOOSE DURING THE SURGERY, BUT WAS ABLE TO BE USED AS INTENDED, TO HAMMER THE NAIL DOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527996 ↗
• MalfunctionJul 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6). 2022, THE TWO PIECES COULD NOT BE SEPARATED AFTER USE. ANOTHER SET OF INSTRUMENTS WAS USED FOR THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065651 ↗
• MalfunctionJul 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TWO PIECES COULD NOT BE SEPARATED AFTER USE. ANOTHER SET OF INSTRUMENTS WAS USED FOR THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065607 ↗
• MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT FOLLOWING A TIBIAL NAILING SURGERY ON (B)(6) 2022, THE CONNECTOR AND INSERTION HANDLE WERE JAMMED NOT ABLE TO BE DISASSEMBLED. IN THE PROCEDURE, THE CONNECTOR AND INSERTION HANDLE WERE ASSEMBLED BEFORE THE NAIL WAS INTRODUCED INTO THE MEDULLARY CANAL. DURING INSERTION, THE SURGEON HAMMERED THE CONNECTOR TO GET THE NAIL PROPERLY INSERTED. THE ASSEMBLING WAS DONE ACCORDING TO RECOMMENDED OPERATION TECHNIQUE AND IFU. FURTHER DISASSEMBLY EFFORT WAS MADE BOTH AFTER WASHING AND STERILISATION AT THE HOSPITAL AND ALSO AFTER RETURN AT THE DISTRIBUTOR¿S OFFICE WITH NO SUCCESS. PROCEDURE WAS COMPLETED WITH NO DELAY. THIS REPORT IS FOR A DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192785 ↗
• MalfunctionApr 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STERILE PROCESSING DEPARTMENT ATTEMPTED TO TAKE APART A STANDARD INSERTION HANDLE FROM A DRIVING CAP WITH HANDLE ADAPTER BUT THEY ARE ACTING LIKE THEY ARE COLD WELDED AND WILL NOT DISASSEMBLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS REPORT IS FOR THE DRIVING CAP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187610 ↗
• MalfunctionApr 19, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, DURING A PROCEDURE TO TREAT A TIBIAL FRACTURE WITH THE EXPERT NAIL, THERE WERE DIFFICULTIES DISCONNECTING THE INSERTION GUIDE FROM THE CONNECTOR. THE THREADS OF THE CONNECTOR WERE DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142512 ↗
• MalfunctionFeb 21, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE THREAD OF THE INSERTION HANDLE ARRIVED DAMAGED AND DID NOT THREAD WELL. THIS REPORT IS FOR ONE (1) CONNEC L141 F/INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13569078 ↗
• MalfunctionNov 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE INSERTION HANDLE WAS FOUND TO BE STUCK IN THE DRIVING CAP WITH HANDLE ADAPTER. THE TWO INSTRUMENTS COULD NOT BE DISASSEMBLED. THE ISSUE WAS FOUND DURING LOAN KIT INSPECTION. THERE WAS NO KNOWN PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820341 ↗
• MalfunctionApr 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EVENT OCCURRED INTRAOPERATIVELY AND THERE WAS NO PATIENT HARM OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732696 ↗
• MalfunctionMar 12, 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, DURING THE INSPECTION IT WAS NOTICED THAT TWO INSTRUMENTS HAVE COLD WELDED TOGETHER AND CANNOT BE REMOVED. THERE WAS NO SURGERY AND PATIENT INVOLVEMENT ARE REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DRIVING CAP WITH HANDLE ADAPTER. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477646 ↗
• MalfunctionFeb 17, 2021Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SET WAS BROUGHT UP BY CENTRAL STERILE WITHOUT BOTH PARTS OF THE DRIVING CAP. THE CENTRAL STERILE STAFF WAS UNABLE TO LOCATE THEM AND PRESUMED THAT THEY WERE LOST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337480 ↗
• MalfunctionFeb 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY FOUND THERE TWO DEVICES, THE INSERTION HANDLE AND THE DRIVING CAP WITH HANDLE ADAPTER GO TOGETHER, AND THEY DISASSEMBLE BUT NOT DISASSEMBLE. THEY CLEARLY CROSS THREADED. THIS DID NOT DIRECTLY INVOLVE THE PATIENT. IT DID NOT AFFECT A PATIENT. THEY PUT IT TOGETHER FOR SURGERY AND FOLLOWING SURGERY, THEY WON'T FALL. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262408 ↗
• MalfunctionJan 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT AFTER THE SURGERY WHEN TRYING TO DISMANTLE THE CONNECTOR FROM THE INSERTION HANDLE, THEY WERE STUCK TOGETHER. WHEN THE COMBINATION WRENCH WAS USED, IT BROKE. THIS REPORT IS FOR ONE (1) DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11193890 ↗
• MalfunctionJan 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET THAT THE HANDLE WAS NON-FUNCTIONAL. THE DRIVING CAP WITH HANDLE ADAPTER IS STRUCK ON THE HANDLE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR 1 DRIVING CAP WITH HANDLE ADAPTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11112872 ↗