NA 314.453Recalls & reported problems

Summary

The FDA's MAUDE database contains 232 adverse event reports that list this exact device (DI 10886982188854), received between Mar 17, 2017 and Sep 29, 2026 — classified as 2 injuries, 230 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (155 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 232 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Entrapment of Device

  It was reported that the Screwdriver broke during a case and the broken fragment remained in the head of the Screw.

  Patient problems: Foreign Body In Patient

  MAUDE report 50933100 ↗
• MalfunctionSep 15, 2026Nonstandard Device; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776091 ↗
• MalfunctionSep 15, 2026Nonstandard Device; Device-Device Incompatibility

  It was reported that the screwdriver does not properly engage with the screw head. The slotted portion of the tip is too short and has a different angle compared with the replacement product that the customer is now using.The customer reported the product typically fails after 2 to 3 procedures.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776083 ↗
• MalfunctionSep 4, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50619999 ↗
• MalfunctionSep 4, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50619994 ↗
• MalfunctionAug 24, 2026Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412830 ↗
• MalfunctionAug 24, 2026Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412789 ↗
• MalfunctionAug 24, 2026Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412721 ↗
• MalfunctionAug 24, 2026Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412712 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT A SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING F EXPERIENCED A FAILURE DURING AN ORIF SURGERY FOR A DISTAL RADIUS FRACTURE. AFTER THE PLATE WAS TEMPORARILY FIXED AND DRILLING WAS COMPLETED, THE BUTTRESS PIN COULD NOT BE ATTACHED TO THE SCREWDRIVER SHAFT IN QUESTION, DESPITE CONFIRMING THE CORRECT DEVICES WERE USED. THE SHAFT WAS REPLACED WITH A LONG SCREWDRIVER, WHICH FUNCTIONED PROPERLY. ATTEMPTS TO USE THE ORIGINAL SHAFT AGAIN WERE UNSUCCESSFUL DUE TO DIFFICULTY IN ATTACHMENT, AND IT WAS NOT USED FURTHER IN THE PROCEDURE. INSPECTION BY THE SALES REPRESENTATIVE REVEALED WEAR AND DEFORMATION ON THE SHAFT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY, AND THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110247 ↗
• MalfunctionApr 22, 2026Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2026, THE SCREWDRIVER WAS NOT FITTING IN SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953625 ↗
• MalfunctionApr 21, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE HOLDING SLEEVE DOES NOT PROPERLY HOLD SCREWS. ITEM SCREWDRIVER SLEEVE IS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938220 ↗
• MalfunctionApr 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THE TECH WAS HAVING ISSUES GRABBING THE SCREWS WITH THE SCREWDRIVER AND THEY WOULD FALL OFF BEFORE SHE COULD HAND THEM TO THE SURGEON. THE SCREWDRIVER SHAFT WAS SWITCHED OUT BEFORE THE SURGEON COULD UTILIZE THE INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24863804 ↗
• MalfunctionMar 17, 2026Device-Device Incompatibility

  IT WAS REPORTED THE SHORT T8 DRIVERS, ON THE LOAN SETS WERE NOT RETAINING SCREWS. PROCEDURE WAS COMPLETED BY SWAPPING TO A LONG DRIVER INSTRUMENT. A 2 MINUTE SURGICAL DELAY WAS NOTED. PROCEDURE COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615448 ↗
• MalfunctionMar 2, 2026Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN ORIF FOR OLECRANON FRACTURE WITH THE SCREWDRIVER SHAFT. THE SCREWDRIVER SHAFT WAS STRIPPED BEFORE APPLYING THE TORQUE TO THE 2.7VA LOCKING SCREW DURING FINAL TIGHTENING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490530 ↗
• MalfunctionFeb 23, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE STERILIZATION PROCESS, IT WAS NOTED THAT THE SCREWDRIVER HEAD SHOWS SIGNS OF WEAR AND REQUIRES REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414481 ↗
• MalfunctionJan 30, 2026Device-Device Incompatibility; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THE TIP OF THE SCREWDRIVER SHAFT WAS DAMAGED AND WON¿T FIT INTO THE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223524 ↗
• MalfunctionJan 26, 2026Material 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 24180235 ↗
• MalfunctionJan 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT UNKNOWN SURGERY. DURING SURGERY, THE PRODUCT IN QUESTION COULD NOT HOLD A TCP 2.4 LOCKING SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON REQUESTED AN INVESTIGATION INTO QUALITY CONTROL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129572 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF TRANSCONDYLAR FRACTURE OF THE DISTAL HUMERUS WITH THE SCREWDRIVER. DURING SURGERY, THE SURGEON TRIED TO INSERT A SCREW USING THE SCREWDRIVER, BUT THE TIP WAS ROUNDED FROM THE START AND DID NOT BITE INTO THE SCREW HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. THE SURGEON EXPRESSED DISSATISFACTION WITH THE INSPECTION PRACTICES, POINTING OUT THAT THIS HAD CAUSED A SIGNIFICANT LOSS OF RELIABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647729 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF FOR OLECRANON FRACTURE WITH THE SCREWDRIVER. DURING SURGERY, WHEN ATTEMPTING TO INSERT A VA2.7 LOCKING SCREW, THE SCREWDRIVER STRIPPED AND IT COULD NOT BE LOCKED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. A SIMILAR CASE HAD RECENTLY OCCURRED, SO THE SURGEON REQUESTED AN INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647414 ↗
• MalfunctionNov 14, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SCREWDRIVER WAS NOT HOLDING SCREWS ON WELL. THE SURGEON NOTED THAT THE EDGES OF THE SCREWDRIVER BLADE LOOKED ROUNDED OFF AND SAID IT NEEDS TO BE REPLACED. ANOTHER SET WAS OPENED FOR A NEW SCREWDRIVER. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555768 ↗
• MalfunctionNov 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF FOR DISTAL HUMERUS FRACTURE WITH THE SCREWDRIVER. DURING THE SURGERY, THE SURGEON COULDN¿T APPLY TORQUE PROPERLY SINCE THE TIP OF THE SCREWDRIVER WAS STRIPPED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534958 ↗
• MalfunctionNov 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY USING DHP TO TREAT THE DISTAL HUMERUS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE HOSPITAL REPORTED THAT THE SCREWDRIVER SHAFT WORE DOWN EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524691 ↗
• MalfunctionOct 28, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE SCREWDRIVER SHAFT DID NOT ENGAGE WITH THE SCREW HEAD PROPERLY PROBABLY BECAUSE IT HAD BEEN DEFORMED, AND TORQUE COULD NOT BE APPLIED. THE SURGEON USED ANOTHER SCREWDRIVER SHAFT AND INSERTED THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408683 ↗