NA 03.010.107Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10886982067791), received between May 22, 2017 and Feb 2, 2026 — classified as 4 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Material Twisted/Bent

  IT WAS REPORTED DEVICES HAVE BECOME WORN OUT AND NO LONGER ATTACH TO THE IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233390 ↗
• MalfunctionAug 6, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A DISTAL FEMUR WITH THE SURGEON, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS A SURGICAL DELAY BUT NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729025 ↗
• MalfunctionAug 6, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A DISTAL FEMUR WITH THE SURGEON, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS A SURGICAL DELAY BUT NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728112 ↗
• MalfunctionApr 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TIP OF THE SCREWDRIVER IS A BIT ROLLED WHICH MAKES IT SLIP EASILY FROM THE HEAD OF THE SCREW WHEN IMPLANTING IT. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19181040 ↗
• MalfunctionFeb 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE THE CONNECTING SCREW WAS STRIPPING AT THE TIME OF REMOVAL. THEY FINALLY REMOVED WITH A DIFFERENT T HANDLE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. AFTER THE CASE THEY WERE ABLE TO IDENTIFY THE OTHER SETS ALSO HAD DAMAGED OR ¿EXTREME WEAR¿ ON THE T25 DRIVERS , CONNECTING SCREWS AND T HANDLES. THE SURGEON REQUESTED TO REPLACE THESE ITEMS AS THEY WERE KEY COMPONENTS TO SUCCESSFULLY REMOVING THE INSERTION HANDLE AFTER SURGERY. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18769434 ↗
• MalfunctionFeb 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON FEBRUARY 1, 2024, DURING THE PROCEDURE THE CONNECTING SCREW WAS STRIPPING AT THE TIME OF REMOVAL. THEY FINALLY REMOVED WITH A DIFFERENT T HANDLE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. AFTER THE CASE THEY WERE ABLE TO IDENTIFY THE OTHER SETS ALSO HAD DAMAGED OR ¿EXTREME WEAR¿ ON THE T25 DRIVERS , CONNECTING SCREWS AND T HANDLES. THE SURGEON REQUESTED TO REPLACE THESE ITEMS AS THEY WERE KEY COMPONENTS TO SUCCESSFULLY REMOVING THE INSERTION HANDLE AFTER SURGERY. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18769395 ↗
• MalfunctionFeb 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON 01-FEBRUARY-2024 DURING A PROCEDURE, THE CONNECTING SCREW WAS STRIPPING DURING REMOVAL. THE SCREW WAS ULTIMATELY REMOVED USING A DIFFERENT T-HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. AFTER THE PROCEDURE, OTHER SETS OF DRIVERS, CONNECTING SCREWS AND T-HANDLES WERE IDENTIFIED WITH DAMAGE OR EXTREME WEAR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18703312 ↗
• MalfunctionFeb 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A PROCEDURE, THE CONNECTING SCREW WAS STRIPPING DURING REMOVAL. THE SCREW WAS ULTIMATELY REMOVED USING A DIFFERENT T-HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. AFTER THE PROCEDURE, OTHER SETS OF DRIVERS, CONNECTING SCREWS AND T-HANDLES WERE IDENTIFIED WITH DAMAGE OR EXTREME WEAR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18703308 ↗
• MalfunctionFeb 14, 2024Material Twisted/Bent; Material Twisted/Bent

  THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18703145 ↗
• MalfunctionFeb 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON 01-FEBRUARY-2024 DURING A PROCEDURE, THE CONNECTING SCREW WAS STRIPPING DURING REMOVAL. THE SCREW WAS ULTIMATELY REMOVED USING A DIFFERENT T-HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. AFTER THE PROCEDURE, OTHER SETS OF DRIVERS, CONNECTING SCREWS AND T-HANDLES WERE IDENTIFIED WITH DAMAGE OR EXTREME WEAR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18703034 ↗
• MalfunctionJan 22, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON JANUARY 6, 2024, THAT THE SCREWDRIVER WITH A WORN STARDRIVE TIP SCREWS EASILY ROLLED. IT HAS NEGATIVE EFFECTS AND GENERATES DISAGREEMENT IN THE SPECIALIST BY INCREASING THE DEGREE OF DIFFICULTY TO SCREW. THIS REPORT IS FOR ONE (1) SCRDRIVER T25 L330 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18554502 ↗
• MalfunctionDec 8, 2023Break; Crack; Material Deformation; Break; Crack; Material Deformation

  IT WAS REPORTED THAT NOVEMBER 16,2023 THE DEVICES WERE DISCOVERED CHIPPED, DENTED, AND CRACKED. NO PATIENT OR PROCEDURE INVOLVED. IT IS UNKNOWN WHEN THE MALFUNCTIONS OCCURRED. THIS REPORT IS FOR SDDRIVE SCREWDRIVER T25/SELF-RETAINING FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18294450 ↗
• MalfunctionDec 8, 2023Break; Crack; Material Deformation; Break; Crack; Material Deformation

  IT WAS REPORTED THAT (B)(6) 2023 THE DEVICES WERE DISCOVERED CHIPPED, DENTED, AND CRACKED. NO PATIENT OR PROCEDURE INVOLVED. IT IS UNKNOWN WHEN THE MALFUNCTIONS OCCURRED. THIS REPORT IS FOR SDDRIVE SCREWDRIVER T25/SELF-RETAINING FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18294239 ↗
• MalfunctionSep 28, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON SEPTEMBER 13, 2023, THE TIPS OF THE SCREWDRIVERS HAVE WORN OUT. THIS WAS IDENTIFIED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. THERE ARE NO FURTHER DETAILS AVAILABLE. THIS REPORT INVOLVES ONE STARDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835592 ↗
• MalfunctionMay 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE LFN NAIL PLACEMENT PROCEDURE WAS STARTED, THE DISTAL HOLES WERE BLOCKED AND THE 4.2 DRILL BIT WAS PASSED, PASSING THE LAST SCREW IT WAS EVIDENT THAT THE TIP OF THE DRILL BIT BROKE, BUT THIS SMALL PIECE WAS NOT FOUND. ON THE OTHER HAND, WHEN PASSING THE SCREW IN ITS RESPECTIVE SCREWDRIVER, IT ROLLED AND DID NOT FACILITATE ACCESS, SO A CHANGE OF SAID PIECES OF INSTRUMENTS WAS REQUESTED. FEMUR PROCEDURE IS STARTED. AT THE END OF THE SURGERY, THE LOCKING SCREWS ARE PLACED. THE TIP OF THE BLOCK BREAKS AND THE SCREWDRIVER DOES NOT TAKE THE SCREWS WELL, WHICH MAKES THE PROCEDURE DIFFICULT. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4) THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T25/SELF-RETAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864433 ↗
• MalfunctionSep 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE POST OP INSPECTION OF ITEMS WERE CANDY CANED, OR WARPED FROM OVER USAGE. MALLET HAD A ROUGH ETCHING AND BACKSLAP HAD THREADS WORN OUT. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR 1 SDDRIVE SCREWDRIVER T25/SELF-RETAINING THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336866 ↗
• MalfunctionSep 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE POST OP INSPECTION OF ITEMS WERE CANDY CANED, OR WARPED FROM OVER USAGE. MALLET HAD A ROUGH ETCHING AND BACKSLAP HAD THREADS WORN OUT. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1) SDDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336825 ↗
• InjuryJul 20, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ETN SET MARKED FOR ETN PIN EXTRACTION. ALSO SENT ILN UNIVERSAL PIN EXTENSION SET. IT WAS SENT FROM ILN , AND INSTEAD OF SENDING THE ETN EXT SET SENT THE SET OF EXT BROKEN PINS . ANESTHETIZED PATIENT AND SURGEON WITHOUT MATERIAL TO EXTRACT THE PIN .SURGERY TOOK LONG, OPENED SETS AND SETS OF MATERIAL TO TRY TO FIND A SOLUTION THAT ALLOWED THE IMPLANT TO BE REMOVED. DAMAGED PARTS BELONGING TO OTHER INSTRUMENTSTHE PRODUCT COMPLAINT (B)(4) WAS OPENED ON 6/20/2022, FOR A DAMAGED PRODUCT.THERE IS NO FURTHER INFORMATION.THIS REPORT IS FOR ONE (1) SCRDRIVER T25 L330.THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15065085 ↗
• MalfunctionJul 18, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING INSPECTION AT THE HOSPITAL, IT WAS NOTICED THAT THERE WAS A DAMAGED CONNECTING SCREW AND SCREWDRIVER FROM A TIBIAL NAIL TRAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040263 ↗
• MalfunctionNov 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE THE STARDRIVE SCREWDRIVER WOULD NOT RELEASE FROM THE SCREW HEAD AFTER INSERTION OF THE SCREW. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT INVOLVES (1) STARDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862133 ↗
• MalfunctionSep 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR DIAPHYSEAL FRACTURE OF TIBIA. BEFORE THE SURGERY DURING STERILIZATION, IT WAS FOUND THAT AN UNKNOWN OILY LIQUID SUBSTANCE CAME OUT OF THE SCREWDRIVERS. THE SUBSTANCE DOES NOT APPEAR AT THE TIME OF SECOND STERILIZATION. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SCRDRIVER T25 L330. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474720 ↗
• MalfunctionSep 2, 2021Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414188 ↗
• MalfunctionMay 11, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR AN INTRAMEDULLARY NAIL INSERTION SURGERY. DURING THE SURGERY, IT WAS NOTICED THAT THE TIPS OF THE SCREWDRIVERS WERE ROUNDED OFF. AS WELL THE ROD PUSHER END APPEARED TO HAVE BEEN BROKEN OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) STARDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS REPORT IS 1 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809091 ↗
• MalfunctionJan 22, 2021Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED ON DECEMBER 03, 2020, DURING INSPECTION, ONE (1) STARDRIVE SCREWDRIVER TIP HAS CRACKED, SLIGHTLY WARPING, ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WIRE TIP POPPED OUT, ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER HANDLE WAS CRACKED, TWO (2) HANDLE FOR TORQUE LIMITING ATTACHMENT LOCK/UNLOCK MECHANISM IS TOUGH TO PRESS, ONE (1) UNIVERSAL CHUCK WITH T-HANDLE TIP IS WARPED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER T25/SELF-RETAINING THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11215099 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STERILE PROCESSING DEPARTMENT FOUND THE STARDRIVE SCREWDRIVER SELF-RETAINING HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER T25/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077581 ↗