NA 311.431Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10886982187406), received between Oct 15, 2018 and Aug 11, 2026 — classified as 70 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (30 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213510 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT A REMOVAL SURGERY.IN THE SURGERY, THE HANDLE BROKE, AND THE HOSPITAL USED ITS OWN EQUIPMENT AS A REPLACEMENT.THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25004867 ↗
• MalfunctionMar 20, 2026Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652072 ↗
• MalfunctionMar 20, 2026Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652049 ↗
• MalfunctionMar 20, 2026Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652029 ↗
• MalfunctionMar 19, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT SEVERAL DEPTH GAGES ARE BENT/NO LONGER ACCURATE. VA GUIDES WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. SCREWDRIVER SHAFTS WORN DOWN. USF HANDLES ARE SPINNING ON SCREW WHEN SURGEON IS TIGHTENING DOWN SCREWS. TROCARS ARE BENT/UNSTABLE. NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642684 ↗
• MalfunctionFeb 23, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT REMOVAL SURGERY AFTER HIGH TIBIAL OSTEOTOMY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT WAS LATER SCHEDULED FOR REMOVAL SURGERY (CAUSE NOT REPORTED). STERILIZATION OF THE SURGICAL INSTRUMENTS WAS PERFORMED THE DAY BEFORE THE SURGERY. ON THE MORNING OF THE SURGERY, IT WAS FOUND THAT THERE WAS DIRT INSIDE THE STERILIZATION BAG OF THE INSTRUMENTS. UPON CHECKING, IT TURNED OUT THAT THE DIRT WAS FROM THE HANDLE IN QUESTION. THE HANDLE WAS REMOVED FROM THE BAG AND CLEANED AGAIN, BUT THE DIRT DID NOT COME OFF, SO THE HOSPITAL DECIDED TO USE AN OLD LCP LARGE INSTRUMENT FOR THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24413640 ↗
• MalfunctionFeb 12, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT REMOVAL SURGERY AFTER HIGH TIBIAL OSTEOTOMY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE REASON FOR REMOVAL SURGERY IS NOT MENTIONED IN THE COMPLAINT REPORT. STERILIZATION OF THE SURGICAL INSTRUMENTS WAS PERFORMED THE DAY BEFORE THE SURGERY. ON THE MORNING OF THE SURGERY, IT WAS FOUND THAT THERE WAS DIRT INSIDE THE STERILIZATION BAG OF THE INSTRUMENTS. UPON CHECKING, IT TURNED OUT THAT THE DIRT WAS FROM THE HANDLE IN QUESTION. THE HANDLE WAS REMOVED FROM THE BAG AND CLEANED AGAIN, BUT THE DIRT DID NOT COME OFF, SO THE HOSPITAL DECIDED TO USE AN OLD LCP LARGE INSTRUMENT FOR THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24322695 ↗
• MalfunctionFeb 10, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE STAINS WERE OBSERVED ON THE DEVICE FOLLOWING AUTOCLAVE STERILIZATION PRIOR TO SURGERY. THE HOSPITAL INQUIRED ABOUT THE SAFETY OF USING THE PRODUCT WITH THESE STAINS AND IF THERE IS A STERILIZATION METHOD THAT DOES NOT LEAVE STAINS. THE EVENT DID NOT INVOLVE ANY PATIENT OR SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306231 ↗
• MalfunctionNov 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN INTRAMEDULLARY FOREIGN BODY REMOVAL FOR TIBIAL PLATEAU FRACTURE SURGERY WITH THE HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. BEFORE THE SURGERY, THE HANDLE WAS STERILIZED THE DAY BEFORE THE REMOVAL SURGERY, AND A BROWN LIQUID STAINED THE STERILIZATION PACK, SO THE HANDLE WAS CLEANED AGAIN AND AUTOCLAVED AGAIN. THE RESULTS OF THE SECOND RUN COULD NOT BE CONFIRMED. THE STERILIZATION PACK WAS DOUBLE-LAYERED, BUT THE STAIN WAS HEAVY ON THE INSIDE. SINCE THE STAIN HAD SPREAD TO THE OUTER PACK, IT WAS DETERMINED THAT CLEANLINESS COULD NOT BE GUARANTEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451013 ↗
• MalfunctionOct 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF SURGERY FOR OLECRANON FRACTURE ON PROXIMAL ULNA WITH THE PRODUCT IN QUESTION. DURING SURGERY, A FIBROUS FOREIGN OBJECT WAS FOUND INSIDE THE PATIENT'S BODY WHILE USING THE PRODUCT IN QUESTION. IT IS UNKNOWN IF THE FIBROUS FOREIGN OBJECT GOT INTO A GAP IN THE HANDLE OF THE PRODUCT IN QUESTION AND FALL INTO THE PATIENT'S BODY DURING USE OR IF THE FIBERS FROM THE GAUZE ENTER THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280585 ↗
• MalfunctionSep 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE HANDLE WAS WASHED AND DRIED, AND BROWN LIQUID SEEPED OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL PLANNED TO PURCHASE A SILICON HANDLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979605 ↗
• MalfunctionJun 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH HANDLE AND SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, WHEN THE J&J¿S DISTRIBUTOR CLEANED THE INSTRUMENT, AND WAS UNABLE TO REMOVE THE HANDLE AND SCREWDRIVER. THEREFORE, THE J&J¿S DISTRIBUTOR RETURNED THE HANDLE AND SCREWDRIVER IN THAT CONDITION. IN JUN. 10, THE SALES REP WAS INFORMED OF THIS BY THE PERSON IN CHARGE AT THE DISTRIBUTION CENTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350543 ↗
• MalfunctionJun 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT PLATE REMOVAL SURGERY FOR DISTAL RADIUS WITH THE HANDLE. WHEN THE SURGEON WAS STERILIZING THE PRODUCT IN QUESTION, A LIQUID OF THE SAME COLOR AS THE WOODEN HANDLE WAS RELEASED. ALTHOUGH IT WAS QUESTIONABLE WHETHER IT WAS SAFE TO USE, THERE WAS NO OTHER EQUIPMENT PREPARED SO THERE WAS NO CHOICE BUT TO USE IT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303173 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE CANNULATED SCREW. AFTER THE SURGERY ON (B)(6) 2025, THE SCREW WAS REMOVED. THE CAUSE OF THE REMOVAL IS UNKNOWN. DURING THE REMOVAL SURGERY, THE SCREWDRIVER IN QUESTION BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO (B)(4) WHICH REPORT THE REMOVAL SURGERY. THIS PC REPORTS THE SCREWDRIVER BROKE DURING THE REMOVAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333063 ↗
• MalfunctionNov 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE. THE PATIENT, UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCT IN QUESTION. BEFORE THE SURGERY, IT WAS FOUND, THAT THE MOUNTING PART WAS HARD TO MOVE AND COULD NOT BE USED. THE SAME ITEM, WHICH HAD BEEN ARRANGED SEPARATELY WAS USED. THERE WAS NO IMPACT ON THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750521 ↗
• MalfunctionOct 9, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2024 THE QUICK CONNECT SCREWDRIVER HANDLE JAMMED AND WOULD NOT CATCH ONTO SCREWDRIVER SHAFTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412307 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THE REDUCTION FORCEPS AND HANDLE ARE BROKEN. ALTERNATIVE INSTRUMENTS WERE AVAILABLE FOR USE, SO THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT. THE PATIENT OUTCOME WAS REPORTED AS PERFECTLY HEALTHY AND DISCHARGED. THIS REPORT IS FOR A HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919772 ↗
• MalfunctionJun 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING THE PROCEDURE, UPON REMOVING EXISTING HARDWARE, THE SCRUB TECH NEEDED TO SWAP THE SCREWDRIVER SHAFT THAT WAS CONNECTED TO THE QUICK COUPLING HANDLE FOR ANOTHER ONE. THE SCRUB TECH WAS NOT ABLE TO REMOVE THE 2.5 HEX SCREWDRIVER SHAFT FROM THE HANDLE. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS FROM BOTH THE SCRUB TECH AS WELL AS THE SURGEON, IT WAS DECIDED TO OPEN ANOTHER TRAY THAT HAD A QUICK COUPLING HANDLE AND THE PROCEDURE WAS PROCEEDED. ONCE THE PROCEDURE WAS COMPLETED, ANOTHER ATTEMPT WAS MADE TO REMOVE THE SCREWDRIVER SHAFT FROM THE HANDLE. THIS ALSO WAS UNSUCCESSFUL. THE SHAFT CONTINUES TO REMAIN ATTACHED TO THE HANDLE WITHOUT THE ABILITY TO DISASSEMBLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAYS, NEGATIVE OUTCOMES, OR INTERVENTION REQUIRED. THIS REPORT IS FOR ONE (1) LARGE HANDLE WITH QUICK COUPLING THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554538 ↗
• MalfunctionMay 21, 2024Contamination /Decontamination Problem; Mechanical Jam; Contamination /Decontamination Problem; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE AREA OF THE INSTRUMENT CASING UNDER WHERE THE HANDLE WAS PLACED WAS DIRTY/STAINED. THE ATTACHMENT PART OF THE HANDLE DID NOT MOVE WELL, AND THE HOSPITAL DETERMINED THAT THE HANDLE WAS UNLIKELY TO BE USABLE FOR SURGERY, THEREFORE A NEW INSTRUMENT SET WAS ARRANGED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE LARGE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19361000 ↗
• MalfunctionApr 26, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A REMOVAL SURGERY OF PHILOS IMPLANTS. BEFORE THE SURGERY, DURING STERILIZATION, A STAIN WAS OBSERVED ON THE PRODUCT. THE PRODUCT IN QUESTION WAS NOT USED IN THE SURGERY, AND ANOTHER SCREWDRIVER WAS USED IN THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE HANDLE W/QUICK-COUPL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19196114 ↗
• MalfunctionMar 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER COLD WELDED TOGETHER. THE STERILE PROCESSING DEPARTMENT COULD NOT GET IT APART. THERE WERE NO PATIENT CONSEQUENCES; ISSUE WAS NOTED POSTOPERATIVELY. THIS REPORT INVOLVES ONE LARGE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952627 ↗
• MalfunctionDec 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DIFFICULT TO CONNECT THE DRILL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LARGE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18291468 ↗
• MalfunctionNov 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED A LARGE HANDLE WITH QUICK COUPLING WAS DIFFICULT TO REMOVE. NO KNOWN PATIENT INVOLVEMENT. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THIS REPORT IS FOR (B)(4). FOR A LARGE HANDLE WITH QUICK COUPLING.

  Patient problems: Insufficient Information

  MAUDE report 18134002 ↗
• MalfunctionSep 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REMOVAL SURGERY WITH THE HANDLE WITH QUICK COUPLING. WHEN THE SURGEON ATTEMPTED TO REMOVE THE VA DISTAL HUMERUS PLATE, THE HANDLE WITH QUICK COUPLING IN QUESTION IDLED. A CLICKING NOISE WAS HEARD COMING FROM THE DRIVER PART. THE SCREWS THEMSELVES COULD BE REMOVED, AND THE SCREW HEADS DID NOT STRIP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE DELAY. THIS REPORT INVOLVES ONE LARGE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17700114 ↗