NA 314.116Recalls & reported problems

Summary

The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 10886982188540), received between May 31, 2017 and Sep 18, 2026 — classified as 5 injuries, 189 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (94 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 194 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829996 ↗
• MalfunctionSep 4, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611981 ↗
• MalfunctionSep 4, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611971 ↗
• MalfunctionSep 4, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611962 ↗
• MalfunctionSep 3, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50590094 ↗
• MalfunctionAug 13, 2026Material Twisted/Bent

  It was reported there was wear and tear on screwdrivers and stripped threads on VA condylar aiming arm. No patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233532 ↗
• MalfunctionAug 13, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233519 ↗
• MalfunctionAug 13, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233485 ↗
• MalfunctionAug 13, 2026Material Twisted/Bent

  It was reported there was wear and tear on screwdrivers and stripped threads on VA condylar aiming arm. No patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233206 ↗
• MalfunctionJul 29, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067700 ↗
• MalfunctionJul 27, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038633 ↗
• MalfunctionMay 26, 2026Break; Material Deformation

  IT WAS REPORTED THAT A VARIETY OF INSTRUMENTS WERE WARPED OR BROKEN. THERE WAS NO REPORTED PATIENT OR USER HARM AND THERE WAS NO DELAY IN SURGERY. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291506 ↗
• MalfunctionMay 20, 2026Break; Material Deformation

  IT WAS REPORTED SEVERAL INSTRUMENTS WERE NOTED TO BE WARPED OR BROKEN. THE DEVICES HAVE BEEN DISCARDED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232922 ↗
• MalfunctionApr 21, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON THE PROXIMAL HUMERUS WITH THE IMPLANT IN QUESTION. PATIENT LATER UNDERWENT REMOVAL SURGERY. THE REMOVED IMPLANT WAS A PHILOS, AND THE REASON FOR REMOVAL WAS BONE FUSION. IN THE SURGERY, THE SCREWDRIVER TIP TWISTED, PREVENTING THE SCREW (3.5LHS) FROM COMING OUT. THE SCREWDRIVER TIP FELT LIKE IT HAD A ROUNDED EDGE, AND THE FIT INTO THE REMOVED SCREWS FELT WEAK. WITH THE SCREWS THAT WOULDN'T COME OUT, THE SCREWDRIVER TIP JUST SPUN FREELY, AND UPON INSPECTION, IT APPEARED TWISTED AND DEFORMED. THE SURGEON WAS ABLE TO REMOVE ALL THE SCREWS INSIDE THE BODY BY GRINDING THE HEAD WITH AN AIR TOM AND GRIPPING THEM WITH PLIERS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THIRTY MINUTES SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942035 ↗
• MalfunctionFeb 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT A SCREWDRIVER SHAFT HAD TWISTED. THERE WAS NO CONCERN OR DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251059 ↗
• MalfunctionJan 26, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE DEVICE STRIPPED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182827 ↗
• MalfunctionJan 26, 2026Device-Device Incompatibility

  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 24180205 ↗
• MalfunctionJan 8, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL FIBULA FRACTURES. AFTER INSERTING THE SCREW THROUGH LCP DISTAL FIBULAR PLATE, THE SCREWDRIVER SHAFT BECAME STUCK IN THE SCREW HEAD AND WOULD NOT DISENGAGE. THE SURGEON REMOVED THE SCREW AND THE SCREWDRIVER SHAFT THAT WERE STUCK TOGETHER AND COMPLETED THE FIXATION USING ANOTHER SCREW AND DRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. THE SCREW AND THE DRIVER WERE SO FIRMLY STUCK TOGETHER THAT THEY HAD TO BE SEPARATED WITH PLIERS, USING A LOT OF FORCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24014586 ↗
• MalfunctionJan 5, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THERE WAS DIFFICULT HWR ON YOUNG KID WITH HARD BONE. SCREWDRIVERS WERE STRIPPED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 23956829 ↗
• MalfunctionDec 10, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767836 ↗
• MalfunctionDec 10, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767834 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF FOR LEFT DISTAL TIBIA AND FIBULA FRACTURE WITH THE SCREW AND THE SCREWDRIVER. AFTER DRILLING AND MEASURING WITH A 2.5 DRILL TIP, THE SCREW WAS INSERTED USING THE SCREWDRIVER TIP (IT IS NOT CLEAR WHICH SCREWDRIVER TIP WAS USED, SO BOTH IN THE SET ARE BEING SUBMITTED). AFTER THE SCREW WAS INSERTED, THE SCREWDRIVER TIP COULD NOT BE REMOVED FROM THE SCREW HEAD, AND WHEN THE SCREWDRIVER WAS PULLED TOWARD THE SURGEON, THE SCREW WAS PULLED OUT ALONG WITH IT. THE SURGEON TRIED TO REMOVE THE SCREW FROM THE SCREWDRIVER TIP ON THE INSTRUMENT TABLE, BUT A CONSIDERABLE AMOUNT OF FORCE WAS REQUIRED. THE USE OF THE SCREW WAS DISCONTINUED, AND A 3.5LHS WAS INSERTED INTO THE SAME COMBINATION HOLE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742170 ↗
• MalfunctionDec 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF FOR LEFT DISTAL TIBIA AND FIBULA FRACTURE WITH THE SCREW AND THE SCREWDRIVER. AFTER DRILLING AND MEASURING WITH A 2.5 DRILL TIP, THE SCREW WAS INSERTED USING THE SCREWDRIVER TIP (IT IS NOT CLEAR WHICH SCREWDRIVER TIP WAS USED, SO BOTH IN THE SET ARE BEING SUBMITTED). AFTER THE SCREW WAS INSERTED, THE SCREWDRIVER TIP COULD NOT BE REMOVED FROM THE SCREW HEAD, AND WHEN THE SCREWDRIVER WAS PULLED TOWARD THE SURGEON, THE SCREW WAS PULLED OUT ALONG WITH IT. THE SURGEON TRIED TO REMOVE THE SCREW FROM THE SCREWDRIVER TIP ON THE INSTRUMENT TABLE, BUT A CONSIDERABLE AMOUNT OF FORCE WAS REQUIRED. THE USE OF THE SCREW WAS DISCONTINUED, AND A 3.5LHS WAS INSERTED INTO THE SAME COMBINATION HOLE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728308 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SEVERAL SCREWDRIVER SHAFTS WERE WARPED AND NOT ABLE TO RETAIN SCREWS CORRECTLY. SALES REP WAS RESTOCKING TRAYS AND DISCOVERED THE DAMAGED SCREWDRIVERS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085687 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SEVERAL SCREWDRIVER SHAFTS WERE WARPED AND NOT ABLE TO RETAIN SCREWS CORRECTLY. SALES REP WAS RESTOCKING TRAYS AND DISCOVERED THE DAMAGED SCREWDRIVERS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085580 ↗