NA 03.010.513Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982069276), received between Jul 10, 2019 and Feb 4, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE TIP OF THE STARDRIVE SCREWDRIVER WAS STRIPPED AND DAMAGED. THIS ITEM WAS DEEMED TO BE NO LONGER FUNCTIONAL AND WAS SUBSEQUENTLY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261657 ↗
• MalfunctionMay 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO REMOVE THE CLOSURE CAP BECAUSE THE SCREWDRIVER SENT TO SURGERY WAS IN POOR CONDITION, TOO WORN AND SLIPPED. THE PATIENT WAS AFFECTED, THEY ANESTHETIZED THE PATIENT, MADE INCISIONS AND IT WAS NOT POSSIBLE TO EXTRACT THE MATERIAL.

  Patient problems: Insufficient Information

  MAUDE report 22054268 ↗
• MalfunctionJun 5, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A TREPHINE FROM THE BROKEN SCREWS WAS DAMAGED. THE TWO TFNA LOCKING SCREWDRIVERS, SINCE THE TFN LOCKING SCREW WAS SOLDERED TO THE PLATE. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER/T25 SELF RETAINING/250MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064631 ↗
• MalfunctionFeb 21, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 29,2023, THE TIP OF THE SCREW DRIVER AND THE LONG SHAFT REAMER WAS BROKEN. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER/T25 SELF RETAINING/250MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413369 ↗
• MalfunctionFeb 21, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE TIP OF THE SCREW DRIVER AND THE LONG SHAFT REAMER WAS BROKEN. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER/T25 SELF RETAINING/250MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413239 ↗
• MalfunctionFeb 21, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 29,2023, THE TIP OF THE SCREW DRIVER AND THE LONG SHAFT REAMER WAS BROKEN. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER/T25 SELF RETAINING/250MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413230 ↗
• MalfunctionFeb 3, 2023Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE DEVICES WERE UNABLE TO USE OR STERILIZE AND ASSEMBLE, BECAUSE THE OF CHIPPING AND CRACKING. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER/T25 SELF RETAINING/250 THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300457 ↗
• MalfunctionFeb 3, 2023Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE DEVICES WERE UNABLE TO USE OR STERILIZE AND ASSEMBLE, BECAUSE THE OF CHIPPING AND CRACKING. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER/T25 SELF RETAINING/250. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300316 ↗
• MalfunctionOct 25, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER HEAD CHIPPED OFF WHILE INSERTING A SCREW DURING A CASE. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE STARDRIVE SCREWDRIVER/T25 SELF RETAINING/250MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666817 ↗
• MalfunctionAug 1, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS SEEM TO HAVE BEEN AFFECTED BY THE HIGH TEMPERATURES OF THE WASHING/STERILIZATION PROCESS. SOME OF THE PLASTICS MELTED AND THE RUBBERS ON SOME TOOLS ARE OILY AND STICKY. THERE IS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER/T25 SELF RETAINING/250MM. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138059 ↗
• MalfunctionAug 10, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A STARDRIVE SCREWDRIVER WAS STRIPPED ON THE TIP AND UNABLE TO ENGAGE THE SCREW RECESS. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER/T25 SELF RETAINING/250MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10385123 ↗
• MalfunctionDec 3, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SHORT T25 SCREWDRIVERS (03.010.513 X2) ARE STRIPPED ON THE TIP AND NO LONGER ENGAGE IN THE SCREW RECESS. ALSO, THE 2.4MM VA-LCP ¿CONE¿ DRILL GUIDE (03.110.000 X1) IS DAMAGED AND WILL NOT ENGAGE IN THE HOLES OF A PLATE. CONCOMITANT DEVICES: UNKNOWN SCREW ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN PLATE ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER/T25 SELF RETAINING/250MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405017 ↗
• MalfunctionDec 3, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SHORT T25 SCREWDRIVERS (03.010.513 X2) ARE STRIPPED ON THE TIP AND NO LONGER ENGAGE IN THE SCREW RECESS. ALSO, THE 2.4MM VA-LCP ¿CONE¿ DRILL GUIDE (03.110.000 X1) IS DAMAGED AND WILL NOT ENGAGE IN THE HOLES OF A PLATE. CONCOMITANT DEVICES: UNKNOWN SCREW ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN PLATE ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER/T25 SELF RETAINING/250MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404920 ↗
• MalfunctionJul 10, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON JUNE 12, 2019, THE MEDICAL DEVICE REPROCESSING (MDR) INDICATED THAT A SCREWDRIVER STARDRIVE WAS WORN AND DAMAGED. PRODUCT IS NO LONGER FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER/T25SELF RETAINING/250MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775408 ↗