NA 03.010.151Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10886982067982), received between Feb 21, 2017 and Sep 30, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (32 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946219 ↗
• MalfunctionMar 20, 2026Material Twisted/Bent

  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 24651783 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  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 24644741 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  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 24642716 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  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 24642636 ↗
• MalfunctionMar 11, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION IT WAS IDENTIFIED THAT THE DEVICE IS STRIPPED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570339 ↗
• MalfunctionMar 3, 2026Material Twisted/Bent

  IT WAS REPORTED SEVERAL DEVICES WERE NOT FUNCTIONING, SOME BROKEN OR STRIPPED. ADDITIONAL DEVICES WERE DETERMINED TO HAVE PARTS STUCK, HAVE FOREIGN MATERIAL IN THE HANDLE OR OTHER FUNCTIONAL ISSUES. THESE ISSUES DID NOT IMPACT PATIENT OUTCOMES. (B)(4) ARE RELATED TO EACH OTHER AND ARE CREATED TO CAPTURE ADDITIONAL IPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498678 ↗
• MalfunctionFeb 18, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER WAS WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377559 ↗
• MalfunctionFeb 5, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER SHAFT IS WORN/STRIPPED AND UNABLE TO INSERT SCREWS. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24269908 ↗
• MalfunctionJan 26, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED MULTIPLE DEVICES ARE NO LONGER FUNCTIONAL. THESE ISSUES DID NOT IMPACT PATIENT OUTCOMES. BELOW DEVICES WERE FOUND TO BE "RELEASE MECHANISM BROKEN" DURING INSPECTION: 03.043.028. BELOW DEVICES WERE FOUND TO BE "STRIPPED THREADS" DURING INSPECTION: 03.120.022, 312.648, 323.029. BELOW DEVICES WERE FOUND TO BE "NUT STUCK ON SLEEVE" DURING INSPECTION: 03.037.017, 03.037.016. BELOW DEVICES WERE FOUND TO BE "HANDLE LEACHING/SPD WIL NOT STERILIZE" DURING INSPECTION: 03.100.018. BELOW DEVICES WERE FOUND TO BE "BROKEN HANDLE" DURING INSPECTION: 311.43. BELOW DEVICES WERE FOUND TO BE "STRIPPED DRILL CONNECTION AND 2ND IS COLD WELDED TO A SCHANZ PIN" DURING INSPECTION: 393.103. BELOW DEVICES WERE FOUND TO BE "BROKEN SLIDING MECHANISM" DURING INSPECTION: 319.091. BELOW DEVICES WERE FOUND TO BE "NOT SNAPPING IN" DURING INSPECTION: 03.120.018, 03.120.017. BELOW DEVICES WERE FOUND TO BE "STRIPPED" DURING INSPECTION: 03.010.151, 314.467, 03.900.042, 03.130.010, 314.453, 03.010.150, 03.010.152. BELOW DEVICES WERE FOUND TO BE "NOT WORKING PROPERLY" DURING INSPECTION: 329.15. BELOW DEVICES WERE FOUND TO BE "NOT LOCKING TENSION BETWEEN TRIGGER PULLS" DURING INSPECTION: 03.221.015. BELOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180974 ↗
• MalfunctionJan 26, 2026Material Twisted/Bent

  IT WAS REPORTED DURING INSPECTION IT WAS FOUND THE DEVICE WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179098 ↗
• MalfunctionJan 16, 2026Material Twisted/Bent

  IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAD ISSUES. THERE WAS NO PATIENT CONSEQUENCE. SCREWDRIVER SHAFT: STRIPPED HEAD FROM USAGE. SCREWDRIVER SHAFT: STUCK IN SHAFT OF HANDLE, UNABLE TO GET IT OUT UNTIL AFTER CASE, SOAKED IN SALINE / WATER (WAS ABLE TO GET OUT A FEW DAYS AFTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099985 ↗
• MalfunctionJan 16, 2026Material Twisted/Bent

  IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAD ISSUES. THERE WAS NO PATIENT CONSEQUENCE. SCREWDRIVER SHAFT: STRIPPED HEAD FROM USAGE SCREWDRIVER SHAFT: STUCK IN SHAFT OF HANDLE, UNABLE TO GET IT OUT UNTIL AFTER CASE, SOAKED IN SALINE / WATER (WAS ABLE TO GET OUT A FEW DAYS AFTER)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099984 ↗
• MalfunctionJan 16, 2026Material Twisted/Bent

  IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAD ISSUES. THERE WAS NO PATIENT CONSEQUENCE. SCREWDRIVER SHAFT: STRIPPED HEAD FROM USAGE. SCREWDRIVER SHAFT: STUCK IN SHAFT OF HANDLE, UNABLE TO GET IT OUT UNTIL AFTER CASE, SOAKED IN SALINE / WATER (WAS ABLE TO GET OUT A FEW DAYS AFTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099980 ↗
• MalfunctionJan 16, 2026Material Twisted/Bent

  IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAD ISSUES. THERE WAS NO PATIENT CONSEQUENCE. SCREWDRIVER SHAFT: STRIPPED HEAD FROM USAGE. SCREWDRIVER SHAFT: STUCK IN SHAFT OF HANDLE, UNABLE TO GET IT OUT UNTIL AFTER CASE, SOAKED IN SALINE / WATER (WAS ABLE TO GET OUT A FEW DAYS AFTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099568 ↗
• MalfunctionJan 15, 2026Material Twisted/Bent

  IT WAS REPORTED THAT VA LOCKING PPFX GREATER TROCHANTER RING, VA-LCP PPFX PROXIMAL FEMUR PLATE 3.5/4.5, AND SCRDRIVER SHAFT SELF-HOLDING L165 F/STAR WERE INVOLVED IN A REPORTED EVENT. DURING A PROCEDURE FOR A PPFX FRACTURE, A VASTUS RIDGE PLATE WAS USED AND AFTER SEVERAL SCREWS WERE PLACED, ATTEMPTS TO CONNECT THE GT RING SMALL AND LARGE TO THE PLATE WERE UNSUCCESSFUL DUE TO AN INABILITY TO THREAD THE COMPONENTS TOGETHER. ALL THREE PLATES WERE NOT IMPLANTED IN THE PATIENT, REPORTEDLY DUE TO A POSSIBLE DEFECT IN THE LOCKING MECHANISM BETWEEN THE PLATE AND GT RING PLATES. ADDITIONALLY, THREE T25/3.5 HEX DRIVERS WERE USED AND WERE REPORTED AS STRIPPED, REQUIRING REPLACEMENT. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT, AND SURGERY WAS NOT DELAYED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078571 ↗
• MalfunctionJan 15, 2026Material Twisted/Bent

  IT WAS REPORTED THAT VA LOCKING PPFX GREATER TROCHANTER RING, VA-LCP PPFX PROXIMAL FEMUR PLATE 3.5/4.5, AND SCRDRIVER SHAFT SELF-HOLDING L165 F/STAR WERE INVOLVED IN A REPORTED EVENT. DURING A PROCEDURE FOR A PPFX FRACTURE, A VASTUS RIDGE PLATE WAS USED AND AFTER SEVERAL SCREWS WERE PLACED, ATTEMPTS TO CONNECT THE GT RING SMALL AND LARGE TO THE PLATE WERE UNSUCCESSFUL DUE TO AN INABILITY TO THREAD THE COMPONENTS TOGETHER. ALL THREE PLATES WERE NOT IMPLANTED IN THE PATIENT, REPORTEDLY DUE TO A POSSIBLE DEFECT IN THE LOCKING MECHANISM BETWEEN THE PLATE AND GT RING PLATES. ADDITIONALLY, THREE T25/3.5 HEX DRIVERS WERE USED AND WERE REPORTED AS STRIPPED, REQUIRING REPLACEMENT. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT, AND SURGERY WAS NOT DELAYED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078570 ↗
• MalfunctionJan 15, 2026Material Twisted/Bent

  IT WAS REPORTED THAT VA LOCKING PPFX GREATER TROCHANTER RING, VA-LCP PPFX PROXIMAL FEMUR PLATE 3.5/4.5, AND SCRDRIVER SHAFT SELF-HOLDING L165 F/STAR WERE INVOLVED IN A REPORTED EVENT. DURING A PROCEDURE FOR A PPFX FRACTURE, A VASTUS RIDGE PLATE WAS USED AND AFTER SEVERAL SCREWS WERE PLACED, ATTEMPTS TO CONNECT THE GT RING SMALL AND LARGE TO THE PLATE WERE UNSUCCESSFUL DUE TO AN INABILITY TO THREAD THE COMPONENTS TOGETHER. ALL THREE PLATES WERE NOT IMPLANTED IN THE PATIENT, REPORTEDLY DUE TO A POSSIBLE DEFECT IN THE LOCKING MECHANISM BETWEEN THE PLATE AND GT RING PLATES. ADDITIONALLY, THREE T25/3.5 HEX DRIVERS WERE USED AND WERE REPORTED AS STRIPPED, REQUIRING REPLACEMENT. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT, AND SURGERY WAS NOT DELAYED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078566 ↗
• MalfunctionAug 7, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED A T25 STAR/HEXDRIVE SCREWDRIVER SHAFT T25, 3.5 MM HEXAGONAL SELF RETAINING, QUICK COUPLING, IN BOTH SETS ARE BECOMING WORN AT THE DISTAL TIP THROUGH LONG TERM USE AND IT HAS BEEN NOTED THE SCREWS ARE NOT FITTING PERFECTLY ANYMORE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22740099 ↗
• MalfunctionAug 7, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED A T25 STAR/HEXDRIVE SCREWDRIVER SHAFT T25, 3.5 MM HEXAGONAL SELF RETAINING, QUICK COUPLING, IN BOTH SETS ARE BECOMING WORN AT THE DISTAL TIP THROUGH LONG TERM USE AND IT HAS BEEN NOTED THE SCREWS ARE NOT FITTING PERFECTLY ANYMORE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22740059 ↗
• MalfunctionJun 5, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS STRIPPED AND WON'T HOLD THE SCREW ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153186 ↗
• MalfunctionJan 31, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER HEADS ARE STRIPPED. THEY DO NOT ENGAGE SCREW HEADS PROPERLY ANYMORE. THE REPLACEMENT SCREWDRIVER WAS USED TO PROCEED WITH THE PROCEDURE. THERE WAS A TWO MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285338 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT ON OCTOBER 09, 2024, IT WAS NOTED THAT THE END OF THE SCREWDRIVER IS FRAYED. THERE WAS NO PATIENT CONSEQUENCES AND NO SURGICAL INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451021 ↗
• MalfunctionSep 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE STAR DRIVE WAS WORN DOWN. THE ISSUE WAS NOTED POSTOPERATIVELY. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20312006 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE 3.5HEX SCREWDRIVER BROKE INTRAOPERATIVELY DURING A CASE AT THE HOSPITAL. THE PATIENT WAS NOT IMPACTED AND THE SURGERY WAS ABLE TO BE COMPLETED WITH A BACKUP SCREWDRIVER. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SD/HD SCRWDRVR SFT T25 3.5HEX/SF-RTN 165 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18666751 ↗