NA 03.045.007Recalls & reported problems
Synthes GmbH · SCREWDRIVER / SHORT / XL25 QUICK COUPLING / HEX 12MM · Class 1
Quick summary
This Synthes screwdriver is a short surgical hand tool for driving screws. Reports mostly describe drivers becoming stripped, bent, warped or worn, with broken retention pins and trouble staying connected to handles. There are 38 reports naming its identifier, with no deaths and no injuries, and 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
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10886982292544), received between Apr 22, 2022 and Sep 30, 2026 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (24 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/Bent24
- Material Deformation9
- Device-Device Incompatibility8
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions40
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the Driving Cap f/Insertion Handle, Multihole Drill Sleeve, Trocar yell, ScrDriver-hex 5 flex cann, Extract-Instr f/TFNA Helical Blade+Scr, ScrDriver short XL25, ScrDriver w/Quick-Coupl hex 12 short XL2, Hand lrg cann w/Quick-Coupl Hex12, ConnecScr f/TFNA Helical Blade+Scr, and ScrDriver Shaft self-holding L165 f/Star were associated with wear-related and deformation issues. The reported failures included stripped or worn threads that did not engage securely, deformed holes that made guide wire passage difficult, a bent trocar that did not fit the cannula properly, dull screwdriver features that did not seat securely or function properly, and a handpiece that no longer clicked into screwdriver shafts. There was no patient involvement. The complaint devices were retained by the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946071 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776509 ↗MalfunctionMay 4, 2026Material Twisted/Bent
IT WAS REPORTED THAT STRIPPED DRIVERS - NEED REPLACEMENTS. GOOD BONE HAS TORQUE SCREWDRIVERS ALONG WITH HANDLES. THERE WAS NO PATIENT STATUS OR OUTCOME OR CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25066982 ↗MalfunctionMay 4, 2026Material Twisted/Bent
IT WAS REPORTED THAT STRIPPED DRIVERS - NEED REPLACEMENTS. GOOD BONE HAS TORQUE SCREWDRIVERS ALONG WITH HANDLES. THERE WAS NO PATIENT STATUS OR OUTCOME OR CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25066978 ↗MalfunctionMay 4, 2026Material Twisted/Bent
IT WAS REPORTED THAT STRIPPED DRIVERS - NEED REPLACEMENTS. GOOD BONE HAS TORQUE SCREWDRIVERS ALONG WITH HANDLES. THERE WAS NO PATIENT STATUS OR OUTCOME OR CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25066972 ↗MalfunctionApr 22, 2026Material Twisted/Bent
IT WAS REPORTED THAT DRIVERS ARE STRIPPED AND NEED REPLACEMENTS. GOOD BONE HAS TORQUE SCREWDRIVERS ALONG WITH HANDLES. THERE WAS NO PATIENT STATUS OR OUTCOME OR CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958180 ↗MalfunctionFeb 23, 2026Material Deformation
IT WAS REPORTED ON AN UNKNOWN DATE, THAT ONE INSTRUMENT WAS BENT AND THE OTHER WILL NOT STAY INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24412816 ↗MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025, ITEMS WERE WORN AND WARPED / BROKEN RETENTION PIN, AND NEED TO BE REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556818 ↗MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE RETENTION PINS OF THE INSTRUMENTS WERE WARPED/BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555610 ↗MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE RETENTION PINS OF THE INSTRUMENTS WERE WARPED/BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555607 ↗MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE RETENTION PINS OF THE INSTRUMENTS WERE WARPED/BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555604 ↗MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE RETENTION PINS OF THE INSTRUMENTS WERE WARPED/BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555578 ↗MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE THAT MULTIPLE SCREWDRIVERS WERE NOT SECURING ONTO SCREWS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23089763 ↗MalfunctionAug 14, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREWDRIVER / SHORT / XL25 QUICK COUPLING / HEX 12MM CENTERING PIN WAS STUCK INSIDE THE POWER SCREWDRIVER. THIS WAS FOUND AFTER CLEANING BY SPD. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806168 ↗MalfunctionAug 13, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT WORN PRODUCTS THAT DON¿T CONNECT, DON¿T TIGHTEN AND ARE UNABLE TO CONNECT / ARE BUSTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22792948 ↗MalfunctionAug 13, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT WORN PRODUCTS THAT DON¿T CONNECT, DON¿T TIGHTEN AND ARE UNABLE TO CONNECT / ARE BUSTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22792939 ↗MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT WORN PRODUCTS THAT DON¿T CONNECT, DON¿T TIGHTEN AND ARE UNABLE TO CONNECT / ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790332 ↗MalfunctionJun 27, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS ALLEGATION AGAINST THE TIBIAL NAIL - THE POLYMER JAMMED IN NAIL WHEN BACKING IT OUT. 8MM BROKE OFF POSTERIOR CORTEX. DRIVERS ARE WARPED FROM USAGE. TNA DRIVE CAP PIN IS FALLING OUT FROM HAMMERING. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345620 ↗MalfunctionJun 27, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS ALLEGATION AGAINST THE TIBIAL NAIL - THE POLYMER JAMMED IN NAIL WHEN BACKING IT OUT. 8MM BROKE OFF POSTERIOR CORTEX. DRIVERS ARE WARPED FROM USAGE. TNA DRIVE CAP PIN IS FALLING OUT FROM HAMMERING. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345613 ↗MalfunctionJun 27, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS ALLEGATION AGAINST THE TIBIAL NAIL - THE POLYMER JAMMED IN NAIL WHEN BACKING IT OUT. 8MM BROKE OFF POSTERIOR CORTEX. DRIVERS ARE WARPED FROM USAGE. TNA DRIVE CAP PIN IS FALLING OUT FROM HAMMERING. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345610 ↗MalfunctionJun 27, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS ALLEGATION AGAINST THE TIBIAL NAIL, POLYMER JAMMED IN NAIL WHEN BACKING IT OUT. THE 8MM BROKE OFF POSTERIOR CORTEX. THE DRIVERS ARE WARPED FROM USAGE. TNA DRIVE CAP PIN IS FALLING OUT FROM HAMMERING. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22344987 ↗MalfunctionSep 11, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE GRAPHIC CASES HAVE WHITE RESIDUE DUE TO CSPD SPRAYING WITH LUBRICANT. DEPTH GAUGE WAS BENT INTRAOP. SHORT POWER SHAFT AND INSERT WERE STRIPPED AND BROKE OFF DURING INSERTING SCREWS. THERE WAS NO PATIENT CONSEQUENCES .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20190530 ↗MalfunctionSep 11, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE GRAPHIC CASES HAVE WHITE RESIDUE DUE TO CSPD SPRAYING WITH LUBRICANT. DEPTH GAUGE WAS BENT INTRAOP. SHORT POWER SHAFT AND INSERT WERE STRIPPED AND BROKE OFF DURING INSERTING SCREWS. THERE WAS NO PATIENT CONSEQUENCES .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20190520 ↗MalfunctionSep 11, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE GRAPHIC CASES HAVE WHITE RESIDUE DUE TO CSPD SPRAYING WITH LUBRICANT. DEPTH GAUGE WAS BENT INTRAOP. SHORT POWER SHAFT AND INSERT WERE STRIPPED AND BROKE OFF DURING INSERTING SCREWS. THERE WAS NO PATIENT CONSEQUENCES .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20190416 ↗MalfunctionJun 27, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2024, THE CONNECTING SCREW THREADS HAVE BEEN DAMAGED AND IT NO LONGER SCREWS INTO THE LAG SCREW SMOOTHLY. THE SHORT XL25 SCREWDRIVER TIP WAS ALSO DAMAGED AND DOES NOT WORK. IT WAS UNSURE WHEN THEY WERE DAMAGED. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. THIS REPORT IS FOR ONE (1) SCREWDRIVER / SHORT / XL25 QUICK COUPLING / HEX 12MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629407 ↗
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.