NA 314.115Recalls & reported problems
Synthes GmbH · STARDRIVE(TM) SCREWDRIVER T15 · Class 1
Quick summary
This Synthes StarDrive screwdriver is a surgical screwdriver used in bone surgery. Many of the 127 reports describe the tool bending, breaking, or cracking, and some describe stains or contamination during sterilization. The reports include no deaths and no injuries. 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
- 127
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 10886982188533), received between Jan 24, 2017 and May 21, 2026 — classified as 127 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (50 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/Bent50
- Break46
- Contamination /Decontamination Problem13
- Crack12
- Device-Device Incompatibility11
- Device Contamination with Chemical or Other Material4
- Material Deformation4
- Peeled/Delaminated2
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Patient Involvement41
- No Consequences Or Impact To Patient13
- Insufficient Information8
- No Known Impact Or Consequence To Patient4
- No Code Available3
Recent adverse event reports
The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Break; Material Deformation
IT WAS REPORTED THAT THERE WERE MULTIPLE ITEMS THAT WERE WARPED OR BROKEN AT THE FACILITY. THERE WAS NO HARM TO THE PATIENT AND NO DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240877 ↗MalfunctionApr 23, 2026Break
IT WAS REPORTED THAT THE DRIVER IS BROKEN. NO FURTHER INFORMATION IS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972885 ↗MalfunctionApr 23, 2026Break
IT WAS REPORTED THAT THE DRIVER IS BROKEN. NO FURTHER INFORMATION IS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972252 ↗MalfunctionMar 18, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626369 ↗MalfunctionJan 20, 2026Contamination /Decontamination Problem
IT WAS REPORTED THE SCREWDRIVER HANDLES ARE LEAVING STAINS ON PEEL PACKS DURING STERILIZATION, THE TIP OF DEPTH GAUGE BROKE DURING CLEANING AND SCREWDRIVER SHAFT IS WORN OUT. EVENT WAS NOTED DURING STERILE PROCESSING AND FIELD INSPECTION. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24120986 ↗MalfunctionJan 20, 2026Contamination /Decontamination Problem
MULTIPLE COMPOSITE HANDLES HAVE BEEN FLAGGED BY THE ACCOUNT DUE TO LEAKING/BROWN STAINING IN THE TRAYS; CAUSING STERILITY CONCERN. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24116502 ↗MalfunctionJan 5, 2026Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS DIFFICULT HWR ON YOUNG KID WITH HARD BONE. SCREWDRIVERS WERE STRIPPED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 23956644 ↗MalfunctionJan 5, 2026Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS DIFFICULT HWR ON YOUNG KID WITH HARD BONE. SCREWDRIVERS WERE STRIPPED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 23956634 ↗MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON NOV 14, 2025, THAT DEVICE HAS STRIPPED STAR TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717586 ↗MalfunctionOct 24, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2025 THAT WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS THEY NOTICED THAT THERE WERE 3 INSTRUMENTS THAT WERE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT AND 1 OF THE ITEMS THEY DID NOT KNOW THE LOT NUMBER ON. 1. THE TIP OF THIS DEPTH GAUGE WAS BROKE OFF. 2. THE TIP OF THIS REAMER SHAFT WAS STRIPPED AND THE RIA HEADS WILL NOT SEAT FULLY. 3. THE SCREWDRIVER WAS STRIPPED AND THE FACILITY DISPOSED OF IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378036 ↗MalfunctionAug 8, 2025Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT TODAY WHILE DOING A CLAVICLE CASE AT HOSPITAL, DOCTOR STRIPPED 7 TOTAL SCREWS AND COMPLAINED ABOUT THE SCREWDRIVERS/QUALITY OF THE SCREWS. NO BROKEN SCREWS WERE LEFT IN THE PATIENT. THE STRIPPED SCREWS WERE DISCARDED BY THE STAFF. (B)(4) IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22749436 ↗MalfunctionJul 31, 2025Break; Break
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING STAFF INSPECTED THE SCREWDRIVER. UPON INSPECTION IT WAS NOTICED THE HANDLE WAS SPLIT IN TWO PIECES STARTING AT THE BOTTOM OF THE HANDLE WORKING UP TO THE SHAFT. THIS DOES NOT ALLOW STAFF TO PROPERLY SANITIZE THE INSTRUMENT AND CAN CAUSE A RISK OF CONTAMINATION TO FUTURE PATIENTS. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22675612 ↗MalfunctionJul 1, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025. THE TIP OF THE SCREWDRIVER BROKE OFF DURING INSERTION. A REPLACEMENT SCREWDRIVER WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22371349 ↗MalfunctionJun 4, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE HANDLE SPLIT, NEED REPLACEMENT FOR SPD TO STERILIZE. THE ITEM IS NO LONGER FUNCTIONAL AND IN NEED OF REPLACEMENT. THESE ISSUES DID NOT IMPACT PATIENT OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143027 ↗MalfunctionJun 4, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE HANDLE SPLIT, NEED REPLACEMENT FOR SPD TO STERILIZE. THE ITEM IS NO LONGER FUNCTIONAL AND IN NEED OF REPLACEMENT. THESE ISSUES DID NOT IMPACT PATIENT OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143008 ↗MalfunctionApr 25, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility
Patient problems: Insufficient Information
MAUDE report 21913377 ↗MalfunctionApr 25, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility
Patient problems: Insufficient Information
MAUDE report 21913375 ↗MalfunctionApr 25, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility
Patient problems: Insufficient Information
MAUDE report 21913373 ↗MalfunctionApr 25, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility
Patient problems: Insufficient Information
MAUDE report 21913372 ↗MalfunctionFeb 4, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER WAS FOUND BY STERILE PROCESSING DURING INSPECTION TO HAVE A DAMAGED TIP. SCREWDRIVER NO LONGER ENGAGES WITH HEAD OF SCREWS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21304951 ↗MalfunctionDec 23, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024 THE SCREWDRIVER WAS FOUND WITH THE TIP BROKEN OFF. THIS WAS FOUND IN STERILE PROCESSING, OUTSIDE OF THE OR SETTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000759 ↗MalfunctionOct 30, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A ROUTINE INSPECTION INDICATED STRIPPED THREADS. UNKNOWN IF THE EVENT OCCUR DURING FIELD INSPECTION OR STERILE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570201 ↗MalfunctionOct 30, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A ROUTINE INSPECTION INDICATED STRIPPED THREADS. UNKNOWN IF THE EVENT OCCUR DURING FIELD INSPECTION OR STERILE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570187 ↗MalfunctionOct 3, 2024Break; Break
IT WAS REPORTED THAT THE HANDLE OF THE T15 WAS SHATTERED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS ALSO NOT KNOWN IF FRAGMENTS WERE GENERATED OR NOT. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20357964 ↗MalfunctionSep 18, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024 THE WOOD HANDLE IS LEACHING. THE EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20246497 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.