NA 03.900.042Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982080691), received between Aug 16, 2017 and Jan 26, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 24180395 ↗
• MalfunctionMar 22, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING INVENTORY CHECKS, IT WAS NOTICED THAT SOME INSTRUMENTS WERE NOT FUNCTIONING PROPERLY. THE END OF THE T25 SCREWDRIVER SHAFT WAS BENT AND COULD NOT CAPTURE SCREWS, AND THE RELEASE PORTION OF THE SMALL UNIVERSAL T-HANDLE CHUCK HAD DETACHED AND COULD NOT BE SCREWED BACK ON. NONE OF THESE INSTRUMENTS WERE USED OR DAMAGED DURING ANY CASES, THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T25 STARDRIVE SCRWDRVR SHAFT 100MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958065 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T25 STARDRIVE SCRWDRVR SHAFT 100MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121674 ↗
• MalfunctionMar 13, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: 03.900.042 WAS RECEIVED AS A BLIND UNIT FROM COLOMBIA ON (B)(6) 2022 IN THE SAME LOANER SET. THERE IS NO ALLEGATION REPORTED AGAINST THE DEVICES. THIS REPORT IS FOR A T25 STARDRIVE SCRWDRVR SHAFT 100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529650 ↗
• MalfunctionMar 22, 2019Naturally Worn; Naturally Worn

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, DURING DECONTAMINATION, A SCREWDRIVER SHAFT WAS FOUND TO BE WORN OUT AND IT CANNOT BE USED. THERE WAS NO SURGICAL PROCEDURE NOR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8445953 ↗
• MalfunctionMar 1, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWDRIVER SHAFT WAS FOUND BADLY WORN DURING DECONTAMINATION. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SCREWDRIVER SHAFT 100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8382889 ↗
• MalfunctionAug 16, 2017Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SCREWDRIVER SHAFT IS TWISTED AROUND ITS AXIS. THIS WAS DETECTED INTRA-OPERATIVELY; THE PROCEDURE SUCCESSFULLY COMPLETED. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. WHEN THE DEVICE WAS RECEIVED BY THE MANUFACTURER, IT WAS NOTED THAT THE SCREWDRIVER SHAFT IS BROKEN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6796880 ↗