NA 03.110.007Recalls & reported problems
Synthes GmbH · STARDRIVE SCREWDRIVER T8 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes StarDrive screwdriver is a surgical screwdriver used with screws. The FDA records hold 97 reports, with no deaths and no injuries; many describe the tip stripping, twisting or breaking, and the handle or parts coming off. Reports fell to 3 in the last 12 months from 11 in the prior 12 months. 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
- 106
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10886982071859), received between Feb 6, 2017 and Sep 17, 2026 — classified as 106 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (43 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent43
- Break33
- Material Deformation18
- Device-Device Incompatibility15
- Contamination /Decontamination Problem4
- Bent3
- Crack3
- Dull, Blunt3
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- No Patient Involvement14
- No Known Impact Or Consequence To Patient7
- Insufficient Information4
- No Consequences Or Impact To Patient4
- No Code Available1
Recent adverse event reports
The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809135 ↗MalfunctionSep 16, 2026Material Twisted/Bent
It was reported several instruments were worn.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787732 ↗MalfunctionSep 16, 2026Material Twisted/Bent
It was reported several instruments were worn.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787311 ↗MalfunctionSep 16, 2026Material Twisted/Bent
It was reported several instruments were worn.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787301 ↗MalfunctionSep 16, 2026Material Twisted/Bent
It was reported several instruments were worn.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787278 ↗MalfunctionSep 16, 2026Material Twisted/Bent
It was reported several instruments were worn.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785380 ↗MalfunctionSep 16, 2026Material Twisted/Bent
It was reported several instruments were worn.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785360 ↗MalfunctionAug 19, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50326418 ↗MalfunctionAug 14, 2026Break; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50257536 ↗MalfunctionApr 28, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVER TIP WAS STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25021301 ↗MalfunctionMar 5, 2026Break; Use of Device Problem
IT WAS REPORTED THAT THE HANDLE OF THE SCREWDRIVER FROM 2.4 VA DISTAL RADIUS SET WAS BROKEN AND PIECE WAS MISSING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519222 ↗MalfunctionNov 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT TIP OF DEVICE IS STRIPPED. NO OPERATION INVOLVED. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544353 ↗MalfunctionSep 15, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025, THE FORCEP'S SCREW FELL OUT, CAUSING THE DEVICE TO SPLIT IN TWO PIECES. ALSO, SILVER CAP ON BACK OF THE SCREWDRIVER FELL OUT. NO OPERATION INVOLVED. NO CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23052569 ↗MalfunctionMay 29, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE WOODEN SCREWDRIVER HANDLE WAS CRACKED AND BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22103912 ↗MalfunctionMay 27, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ONE DRIVER HAD A STRIPPED TIP AND THE OTHER ONE WAS MISSING THE SILVER KNOB FROM THE BACK OF THE HANDLE. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22087066 ↗MalfunctionMay 12, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2025 THE INSTRUMENT TIP WAS TWISTED. DOESN'T WORK WITH SCREWS. NO OPERATION INVOLVED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002708 ↗MalfunctionMay 12, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON APRIL 18,2025 THE INSTRUMENT TIP WAS TWISTED. DOESN'T WORK WITH SCREWS. NO OPERATION INVOLVED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002689 ↗MalfunctionApr 1, 2025Break; Break
IT WAS REPORTED THAT THE SCREWDRIVER CAME INTO THE DECONTAMINATION AREA WITH SEPARATION. IT WAS IDENTIFIED IN THE DECONTAMINATION AREA POST OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21746219 ↗MalfunctionJan 23, 2025Break; Break
IT WAS REPORTED THAT THE HANDLE IS BROKEN AND MISSING A PIECE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21218547 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178173 ↗MalfunctionDec 13, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024. THE SCREWDRIVER RECESS STRIPPED DURING EXTRACTION OF SCREW STUCK IN A PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY.
Patient problems: Insufficient Information
MAUDE report 20924368 ↗MalfunctionDec 13, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOW PROCEDURE ON AN UNKNOWN DATE IN 2024. THE SCREWDRIVER RECESS STRIPPED DURING EXTRACTION OF SCREW STUCK IN A PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY.
Patient problems: Insufficient Information
MAUDE report 20924361 ↗MalfunctionDec 4, 2024Break; Break
IT WAS REPORTED THAT ON NOVEMBER 21, 2024, THE BACK PLATE OF THE DEVICE FALLS OUT. THERE WAS NO PATIENT OR OPERATION INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20843263 ↗MalfunctionSep 27, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024, THE T8 SCREWDRIVER WAS FAILING TO RETAIN SCREWS. UPON FURTHER INSPECTION, THE TIP HAD DEVELOPED A TWIST. ANOTHER DRIVER WAS OPENED TO COMPLETE THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20320765 ↗MalfunctionSep 18, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THE SHAFT OF THE COMPLAINED ITEM BECAME LOOSE AT THE CONNECTION POINT TO THE REST OF THE INSTRUMENT. ALSO, STAFF IDENTIFIED THAT STAR-DRIVE TIP OF THE ITEM BECAME DEFORMED AND WOULD NO LONGER FUNCTION TO FIT INTO A T8 SCREW HEAD RECESS. A THIRD DISCOVERY WAS MADE BY STAFF THAT THE TIP OF ITEM HAD BECOME STRIPPED AND WOULD NO LONGER PROPERLY ENGAGE THE SCREW HEAD RECESS OF A STAR-DRIVE SCREW. THESE 3 INSTRUMENTS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T8. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20246617 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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