NA 314.467Recalls & reported problems
Synthes GmbH · STARDRIVE SCREWDRIVER SHAFT T8 105MM · Class 1
Quick summary
This Synthes StarDrive screwdriver shaft is a surgical tool used to drive screws during orthopedic procedures. Most of its 491 reports describe a shaft that is bent or twisted, sometimes breaking or not fitting other devices. Most reports describe no clinical signs in patients, and the reports include 6 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 498
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 498 adverse event reports that list this exact device (DI 10886982188922), received between Dec 14, 2016 and Sep 29, 2026 — classified as 6 injuries, 492 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (340 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent340
- Device-Device Incompatibility114
- Break59
- Material Deformation49
- Bent11
- Entrapment of Device7
- Dull, Blunt6
- Peeled/Delaminated6
Patient problems
- No Clinical Signs, Symptoms or Conditions346
- No Patient Involvement62
- No Consequences Or Impact To Patient53
- Insufficient Information18
- No Known Impact Or Consequence To Patient13
- Foreign Body In Patient9
- No Code Available6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 498 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 50933122 ↗MalfunctionSep 22, 2026Material Integrity Problem
Patient problems: Insufficient Information
MAUDE report 50857753 ↗MalfunctionSep 10, 2026Device-Device Incompatibility; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722043 ↗MalfunctionSep 4, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50611930 ↗MalfunctionSep 4, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50611920 ↗MalfunctionSep 3, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50590059 ↗MalfunctionSep 3, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50590052 ↗MalfunctionAug 13, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241054 ↗MalfunctionAug 13, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233741 ↗MalfunctionAug 13, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233730 ↗MalfunctionAug 13, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233274 ↗MalfunctionAug 3, 2026Device-Device Incompatibility; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114571 ↗MalfunctionAug 3, 2026Device-Device Incompatibility; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114570 ↗MalfunctionAug 3, 2026Device-Device Incompatibility; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114565 ↗MalfunctionMay 29, 2026Material Twisted/Bent
IT WAS REPORTED THE TIPS OF THE SCREWDRIVERS ARE WORN DOWN. NO PATIENT HARM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330547 ↗MalfunctionMay 29, 2026Material Twisted/Bent
IT WAS REPORTED THE TIPS OF THE SCREWDRIVERS ARE WORN DOWN. NO PATIENT HARM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330543 ↗MalfunctionMay 29, 2026Material Twisted/Bent
IT WAS REPORTED THE TIPS OF THE SCREWDRIVERS ARE WORN DOWN. NO PATIENT HARM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330505 ↗MalfunctionMay 8, 2026Material Deformation; Material Twisted/Bent
DURING ROUTINE MEDICALLY DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE STARDRIVE FRONT TIP OF COMPLAINED ITEMS 3 X 314.467 (SCRDRIVER SHAFT T8 SELF-HOLDING) HAD BECOME WARPED, BENT AND TWISTED AND WOULD NO LONGER SUCCESSFULLY CONNECT WITH THE SCREW HEADS AS THE INSTRUMENT WAS DESIGNED TO. MEDICAL DEVICE REPROCESSING STAFF ALSO IDENTIFIED THAT THE TORQUE LIMITING OF COMPLAINED ITEMS 3 X 511.776 (TORQUE LIMITER 0.8NM W/AO/ASIF-QC) HAD BECOME NOT FUNCTIONAL/CALIBRATED AND WOULD NO LONGER SUCCESSFULLY TORQUE THE SCREWS AS THE INSTRUMENT WAS DESIGNED TO. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. REPLACEMENTS ARE REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25131176 ↗MalfunctionMay 8, 2026Material Deformation; Material Twisted/Bent
DURING ROUTINE MEDICALLY DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE STARDRIVE FRONT TIP OF COMPLAINED ITEMS 3 X 314.467 (SCRDRIVER SHAFT T8 SELF-HOLDING) HAD BECOME WARPED, BENT AND TWISTED AND WOULD NO LONGER SUCCESSFULLY CONNECT WITH THE SCREW HEADS AS THE INSTRUMENT WAS DESIGNED TO. MEDICAL DEVICE REPROCESSING STAFF ALSO IDENTIFIED THAT THE TORQUE LIMITING OF COMPLAINED ITEMS 3 X 511.776 (TORQUE LIMITER 0.8NM W/AO/ASIF-QC) HAD BECOME NOT FUNCTIONAL/CALIBRATED AND WOULD NO LONGER SUCCESSFULLY TORQUE THE SCREWS AS THE INSTRUMENT WAS DESIGNED TO. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. REPLACEMENTS ARE REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25131015 ↗MalfunctionMay 8, 2026Material Deformation; Material Twisted/Bent
DURING ROUTINE MEDICALLY DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE STARDRIVE FRONT TIP OF COMPLAINED ITEMS 3 X 314.467 (SCRDRIVER SHAFT T8 SELF-HOLDING) HAD BECOME WARPED, BENT AND TWISTED AND WOULD NO LONGER SUCCESSFULLY CONNECT WITH THE SCREW HEADS AS THE INSTRUMENT WAS DESIGNED TO. MEDICAL DEVICE REPROCESSING STAFF ALSO IDENTIFIED THAT THE TORQUE LIMITING OF COMPLAINED ITEMS 3 X 511.776 (TORQUE LIMITER 0.8NM W/AO/ASIF-QC) HAD BECOME NOT FUNCTIONAL/CALIBRATED AND WOULD NO LONGER SUCCESSFULLY TORQUE THE SCREWS AS THE INSTRUMENT WAS DESIGNED TO. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. REPLACEMENTS ARE REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25129851 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT THE SCRDRIVER SHAFT T8 SELF-HOLDING BROKE INTO MULTIPLE PIECES DURING A SURGICAL PROCEDURE. THE EVENT OCCURRED INTRAOPERATIVELY WHILE THE DEVICE WAS BEING USED TO PLACE A 2.7 MM CORTICAL SCREW. THE SURGICAL TEAM MANAGED TO COMPLETE THE PROCEDURE SUCCESSFULLY BY UTILIZING ALTERNATIVE EQUIPMENT, WITH NO INCONVENIENCE TO THE SPECIALIST, NO IMPACT OR PREJUDICE TO THE PATIENT, AND NO ALTERATION IN SURGICAL TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056573 ↗MalfunctionApr 20, 2026Material Twisted/Bent
IT WAS REPORTED DURING A REMOVAL SURGERY, THE DHP SCREW STRIPPED, MAKING REMOVAL DIFFICULT. THE SCREW ON THE SUPPORT PART WOULDN'T COME OUT, SO THE PLATE HAD TO BE CUT AND THE ENTIRE PLATE ROTATED TO REMOVE IT. IT WAS NOTED THE SCREWDRIVER ALSO STRIPPED DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926659 ↗MalfunctionApr 8, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR FRACTURE ON HUMERUS WITH THE PRODUCT IN QUESTION. IN THE SURGERY, THE SCREWDRIVER TIP WAS STRIPPED, PREVENTING PROPER TORQUE APPLICATION. THE OPERATION WAS COMPLETED WITHOUT ISSUE USING A DIFFERENT SCREWDRIVER TIP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820154 ↗MalfunctionApr 7, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVERS STRIPPED DURING CASE. THERE WAS A 5 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24805701 ↗MalfunctionApr 7, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVERS STRIPPED DURING CASE. THERE WAS A 5 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24805624 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
- NA 2274-02-000Depuy (Ireland) · SCREWDRIVER303 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.