NA 314.02Recalls & reported problems

Summary

The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 10886982188373), received between Jan 11, 2017 and Sep 28, 2026 — classified as 2 injuries, 164 malfunctions.

The most frequently reported specific device problem is “Break” (66 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 166 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Twisted/Bent

  It was reported that the screwdriver head is stripped due to wear and tear. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913716 ↗
• MalfunctionSep 25, 2026Break

  It was reported the Screwdriver handle broke during a procedure. The procedure was completed successfully with no delay or harm to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899537 ↗
• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697514 ↗
• MalfunctionApr 20, 2026Break; Entrapment of Device

  IT WAS REPORTED A 38-YEAR-OLD PATIENT REQUIRES A REVISION SURGERY FOR THE REMOVAL OF OSTEOSYNTHESIS HARDWARE IMPLANTED ON (B)(6) 2024, FOR A TIBIAL PILON FRACTURE. DURING THE ATTEMPTED REMOVAL OF SCREWS WITH DAMAGED HEAD RECESSES, THE HANDLE OF THE SCREWDRIVER FRACTURED. PARTICLES FROM THE HANDLE ENTERED IN THE SURGICAL WOUND, ANTIBIOTIC PROPHYLAXIS MADE. THE SCREW HEADS HAVE BEEN COUNTERSUNK, AND THE SHANKS LEFT IN PLACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24924860 ↗
• MalfunctionMar 6, 2026Material Twisted/Bent

  IT WAS REPORTED THAT RETENT PIN SCRDRIVER QC HEX 12/SHT/XL25, T15 CANN STRDRV SCRWDRVR SFT SLF-RETAIN, 2.7MM CANN DRILL BIT QC/145MM, SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE, MONOBLOC FLEXIBLE REAMER 14 - STD - DD, MONOBLOC FLEX REAMER 14.5 - LONG - DD, DRIVE SHAFT FOR RIA 2 520MM, T25 SDDRIVE SCREWDRIVER SHAFT 241MM, AND TORQUE LIMITING ATTACHMENT 4NM FOR AO REAMING COUPLER WERE REPORTED AS DAMAGED DURING POST-OPERATIVE INSPECTION. THE FAILURES INCLUDED BROKEN TIPS, STRIPPED FEATURES, RUST INSIDE CANNULAS, AND NON-FUNCTIONING TORQUE LIMITER. THERE WAS NO PATIENT INVOLVEMENT OR HARM, AND NO PROCEDURE WAS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533348 ↗
• MalfunctionJan 28, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER IS STRIPPED, IT DOES NOT ENGAGE SCREW HEADS PROPERLY ANYMORE. A REPLACEMENT SCREWDRIVER WAS USED. THERE WAS A 2 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202915 ↗
• MalfunctionJan 20, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THE SCREWDRIVER HANDLES ARE LEAVING STAINS ON PEEL PACKS DURING STERILIZATION, THE TIP OF DEPTH GAUGE BROKE DURING CLEANING AND SCREWDRIVER SHAFT IS WORN OUT. EVENT WAS NOTED DURING STERILE PROCESSING AND FIELD INSPECTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120538 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT TODAY WHILE DOING A CLAVICLE CASE AT HOSPITAL, DOCTOR STRIPPED 7 TOTAL SCREWS AND COMPLAINED ABOUT THE SCREWDRIVERS/QUALITY OF THE SCREWS. NO BROKEN SCREWS WERE LEFT IN THE PATIENT. THE STRIPPED SCREWS WERE DISCARDED BY THE STAFF. (B)(4) WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748871 ↗
• MalfunctionDec 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SCREWDRIVER HANDLES LEAVE A STAIN ON PEEL PACKS AFTER STERILIZATION PROCESSING. NO PATIENT WAS INVOLVED. THIS EVENT OCCUR DURING FIELD INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920129 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SURGEON WAS STRUGGLING TO USE THE SCREWDRIVER CATCHER ATTACHMENTS THAT HOLDS THE SCREWS. IN A SET, THE SCREWDRIVER CATCHER WAS HOLDING THE SCREWS TOO TIGHTLY AND WOULDN¿T RELEASE THE SCREWS. ON A DIFFERENT SET, THE SCREWDRIVER CATCHER WAS HOLDING THE SCREWS TOO LOOSELY. THIS DID NOT INVOLVE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190047 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SURGEON WAS STRUGGLING TO USE THE SCREWDRIVER CATCHER ATTACHMENTS THAT HOLDS THE SCREWS. IN A SET, THE SCREWDRIVER CATCHER WAS HOLDING THE SCREWS TOO TIGHTLY AND WOULDN¿T RELEASE THE SCREWS. ON A DIFFERENT SET, THE SCREWDRIVER CATCHER WAS HOLDING THE SCREWS TOO LOOSELY. THIS DID NOT INVOLVE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190031 ↗
• MalfunctionSep 10, 2024Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ON AUG 20, 2024 THE BALL IS LOOSE. BROKEN. IT WAS DISCOVERED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCRDRIVER HOLDING SLV THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185852 ↗
• MalfunctionSep 10, 2024Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2024 THE BALL IS LOOSE. BROKEN. IT WAS DISCOVERED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCRDRIVER HOLDING SLV. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185851 ↗
• MalfunctionMar 13, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT PLATES WERE IMPLANTED IN THE PATIENT, THE LOCKING SCREWS DID NOT LOCK IN 1-2 HOLES OF THE PL AND MEDIAL PLATES SO THOSE PLATE HOLES WERE NOT FILLED. THE SURGEON INITIALLY USED A VA GUIDE BUT LATER USED A NON LOCKING DRILL GUIDE. UNSURE IF IT¿S BECAUSE HE USED A METAPHYSEAL SCREW FIRST TO SUCK THE PLATE DOWN, AND THEN CHANGED FOR A VAL. WE¿VE HAD ISSUES WITH THIS PLATE NOT LOCKING, SURGEON DID NOT WANT PATIENT TO BE CHARGED. WHILE INSERTING CORTICAL SCREWS AND A 7.3 CANNULATED FOR THE OLECRANON OSTEOTOMY HE ALSO COMPLAINED OF THE SCREWDRIVER HEADS BEING STRIPPED OR WARPED. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCRDRIVER HOLDING SLV THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897673 ↗
• MalfunctionMar 13, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT PLATES WERE IMPLANTED IN THE PATIENT, THE LOCKING SCREWS DID NOT LOCK IN 1-2 HOLES OF THE PL AND MEDIAL PLATES SO THOSE PLATE HOLES WERE NOT FILLED. THE SURGEON INITIALLY USED A VA GUIDE BUT LATER USED A NON LOCKING DRILL GUIDE. UNSURE IF IT¿S BECAUSE HE USED A METAPHYSEAL SCREW FIRST TO SUCK THE PLATE DOWN, AND THEN CHANGED FOR A VAL. WE¿VE HAD ISSUES WITH THIS PLATE NOT LOCKING, SURGEON DID NOT WANT PATIENT TO BE CHARGED. WHILE INSERTING CORTICAL SCREWS AND A 7.3 CANNULATED FOR THE OLECRANON OSTEOTOMY HE ALSO COMPLAINED OF THE SCREWDRIVER HEADS BEING STRIPPED OR WARPED. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCRDRIVER HOLDING SLV THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897652 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 8, 2024, WHILE INSPECTING INSTRUMENT, THE SPD STAFF NOTICED THAT THE SCREWDRIVER TIP HAD SHEERED OFF OF THE SCREWDRIVER (314.02). IT IS UNKNOWN WHEN THE EVENT HAD OCCURRED. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCRDRIVER HOLDING SLV THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18761223 ↗
• MalfunctionFeb 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, CUSTOMER REPORTED THAT THE SCREWDRIVER HEAD WAS NOT ENGAGING IN THE HEADS OF THE SCREWS. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCRDRIVER HOLDING SLV THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635278 ↗
• MalfunctionJan 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT IN DECEMBER 2023, AFTER VISUAL EXAMINATION, THE DEVICES WERE FOUND TO HAVE THE FOLLOWING CONDITIONS: BENT, BROKEN, AND/OR STRIPPED. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18474265 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT IN DECEMBER 2023, AFTER VISUAL EXAMINATION, THE DEVICES WERE FOUND TO HAVE THE FOLLOWING CONDITIONS: BENT, BROKEN, AND/OR STRIPPED. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18474165 ↗
• MalfunctionDec 15, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 24-NOVEMBER-2023 DURING ROUTINE INSPECTION, THE SCREWDRIVER IN QUESTION WAS FOUND TO BE STRIPPED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334866 ↗
• MalfunctionNov 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 12-OCTOBER-2023 AFTER STERILIZATION, BROWN MARKS WERE SPOTTED ON THE PACKAGING OF THE SINGLE PACKAGE INSTRUMENTS IN QUESTION. ALL INSTRUMENTS HAD RESIN HANDLES. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 2 OF 5 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148111 ↗
• MalfunctionSep 29, 2023Illegible Information; Illegible Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT(B)(6) 2023, WHEN THE STAFF WAS PUTTING BACK THE INSTRUMENTS INTO THE SETS, IT WAS NOTICED THAT THE NUMBERS ETCHED ON THE LABEL OF THE INSTRUMENT WHERE DIFFICULT TO SEE. THE ISSUE WAS NOTICED POST-OP, IN THE INSTRUMENT ROOM, AFTER DECONTAMINATING THE INSTRUMENT. IT WAS FURTHER NOTED THAT A PHOTO PROVIDED BY THE REPORTER SHOWED THAT TWO DEVICES WERE INVOLVED, AND WERE FOUND TO BE BENT AT THE TIPS. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 2 OF 2 FOR(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17845689 ↗
• MalfunctionAug 18, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE END OF THE HEX BROKE OFF INTO THE SCREW. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573247 ↗
• MalfunctionAug 8, 2023Illegible Information; Illegible Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, WHEN THE STAFF WAS PUTTING BACK THE INSTRUMENTS INTO THE SETS, IT WAS NOTICED THAT THE NUMBERS ETCHED ON THE LABEL OF THE INSTRUMENT WHERE DIFFICULT TO SEE. THE ISSUE WAS NOTICED POST-OP, IN THE INSTRUMENT ROOM, AFTER DECONTAMINATING THE INSTRUMENT. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480258 ↗
• MalfunctionJun 27, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON JUNE 7, 2023, THE INSTRUMENTS WERE FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. TWO SCREWDRIVERS WERE FOUND WITH STRIPPED TIPS, AND THE SILVER AP WAS NOT CLICKING INTO THE BLUE HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210556 ↗