NA 03.045.006Recalls & reported problems
Synthes GmbH · RETENTION PIN FOR SCREWDRIVER W/ Q C -HEX 12MM/ XL25 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes retention pin holds a screwdriver's coupling in place during bone fixation surgery. Most of the 47 reports describe the pin breaking or snapping off, sometimes during cleaning, sometimes mid-operation, and in a few cases the broken tip was left inside the patient or in the screw head; others describe bent pins or parts not staying connected. Two reports mention injuries, and there are no deaths or recalls. Reports rose from 9 in the prior 12 months to 14 in the last 12 months.
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
- 49
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10886982292537), received between Oct 12, 2021 and Sep 22, 2026 — classified as 2 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Break” (27 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
- Break27
- Device-Device Incompatibility17
- Material Twisted/Bent12
- Material Deformation7
- Entrapment of Device4
- Device Slipped1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- Foreign Body In Patient4
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Device-Device Incompatibility; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857109 ↗MalfunctionSep 15, 2026Break
It was reported the threads of retention pins have broken off. Event was found post-operatively. No patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770541 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE RETENTION PIN BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25094908 ↗MalfunctionFeb 23, 2026Device Slipped
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 24412903 ↗MalfunctionFeb 10, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY WITH RFNA LONG NAIL FOR FEMORAL SHAFT FRACTURES. WHEN INSERTING THE PROXIMAL SCREW, THE SURGEON FELT THAT THE GRIP MAY HAVE WEAKENED. THE SCREW WAS REMOVED, AND IT WAS VISUALLY CONFIRMED THAT THE TIP OF THE RETENTION PIN BROKE OFF, AND THE BROKEN TIP REMAINED IN THE SCREW HEAD. THE SURGEON REMOVED THE BROKEN TIP FROM THE SCREW HEAD USING HOSPITAL-OWNED FORCEPS AND RE-INSERTED THE SCREW USING ANOTHER SCREWDRIVER. NO BROKEN FRAGMENTS WERE LEFT INSIDE THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24309086 ↗MalfunctionJan 12, 2026Break; Entrapment of Device
IT WAS REPORTED THAT THE RETAINING PIN BROKE AT THE TIP WHERE IT SCREWS INTO THE SCREW HEAD. THE SPECIALIST TIGHTENED THE SCREWDRIVER EXCESSIVELY BEFORE THE RETAINING PIN WAS FULLY RELEASED, RESULTING IN AN AUDIBLE NOISE AND SUBSEQUENT BREAKAGE. IT COULDN'T BE RETRIEVED AND REMAINED INSIDE THE PATIENT. THE SPECIALIST SAID IT WOULDN'T CAUSE ANY HARM TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24046359 ↗MalfunctionDec 17, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025, SPD INFORMED THAT TWO (2) RETENTION PINS FOR SCREWDRIVER WITH QUICK COUPLING, HEXAGONAL 12 MM, SHORT AND ONE (1) RETENTION PIN FOR SCREWDRIVER WITH QUICK COUPLING, HEXAGONAL 12 MM WERE FOUND IN SPD WITH THE RETENTION THREADS BROKEN OFF. THIS WAS FOUND UPON EXAMINATION ON THE CLEAN SIDE OF SPD. IT IS UNCLEAR WHEN THEY BROKE. THERE WAS NO KNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23832454 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE RETENTION PIN TIP WAS BROKEN OFF IN CSPD DURING CLEANING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693950 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE RETENTION PIN TIP WAS BROKEN OFF IN CSPD DURING CLEANING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693943 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE RETENTION PIN TIP WAS BROKEN OFF IN CSPD DURING CLEANING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693911 ↗MalfunctionNov 17, 2025Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025 IT WAS FOUND THAT ITEMS WERE WORN AND NEED TO BE REPLACED. RETENTION PINS WERE WARPED/BROKEN. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23572427 ↗MalfunctionNov 17, 2025Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025 IT WAS FOUND THAT ITEMS WERE WORN AND NEED TO BE REPLACED. RETENTION PINS WERE WARPED/BROKEN. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23572409 ↗MalfunctionNov 17, 2025Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025 IT WAS FOUND THAT ITEMS WERE WORN AND NEED TO BE REPLACED. RETENTION PINS WERE WARPED/BROKEN. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23572368 ↗MalfunctionNov 14, 2025Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; 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 23556826 ↗MalfunctionNov 14, 2025Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; 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 23555628 ↗MalfunctionNov 14, 2025Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; 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 23555616 ↗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 23089765 ↗MalfunctionJul 29, 2025Break; Break
IT WAS REPORTED THAT DURING PROXIMAL LOCKING WITH THE MECHANICAL DRIVE FREEHAND THE CONNECTING SCREW BREAKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22642020 ↗MalfunctionJul 21, 2025Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, THE LONG RETENTION PIN WAS MISSING THE LITTLE THREADED PART FROM THE TIP, AND THE ROD PUSHER IS BENT. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22554744 ↗MalfunctionMay 21, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2025, WHEN INSERTING A 5.0 LOCKING SCREW INTO THE DISTAL HOLE OF THE 170MM TFNA, THE XL25 POWER SCREWDRIVER SHAFT AND RETENTION PIN SNAPPED OFF. THE TIP OF THE SCREWDRIVER POWER SHAFT AND THE THREADS OF THE RETENTION PIN WERE STUCK IN THE HEAD OF THE SCREWDRIVER. THIS KEPT THE SURGEON FROM BEING ABLE TO ADVANCE THE SCREW OR TAKE IT OUT. NO SCREWDRIVER WAS ABLE TO GRAB THE HEAD OF THE SCREW. THIS LEFT THE SCREW PROTRUDING. SURGEON TRIED TO USE ANOTHER SCREWDRIVER TO REMOVE THE SCREW BUT THE HEAD WAS TAKEN UP BY THE SCREWDRIVER PIECES INSIDE IT. SURGERY WAS DELAYED BY 15 MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE PATIENT CONSEQUENCES AS THE PROTRUDING SCREW HEAD MAY CAUSE SOFT TISSUE IRRITATION POST-OP.
Patient problems: Foreign Body In Patient
MAUDE report 22063150 ↗MalfunctionMar 25, 2025Break; Break
IT WAS REPORTED THAT THE SHORT XL25 RETENTION PIN WAS BROKEN FROM BOTH POWER DRIVER AND HAND DRIVER. FRAGMENTS WERE GENERATED. REMOVAL OF BROKEN RETENTION PIN PIECE WAS REQUIRED, AND IT WAS REMOVED WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WERE NO PATIENT CONSEQUENCES. SCREW WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21688142 ↗MalfunctionFeb 28, 2025Break; Break
IT WAS REPORTED THAT THE SCREWDRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21496717 ↗MalfunctionJan 22, 2025Break; Break
IT WAS REPORTED THAT THE TIPS OF THE ITEM HAVE BEEN SNAPPING OFF, SO THE SELF-RETENTION MECHANISM NO LONGER WORKS. NO PATIENT HARM HAS BEEN REPORTED AND ALL CASES HAVE BEEN COMPLETED WITH NO DELAY. NO OTHER INFORMATION WAS ABLE TO BE PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21209991 ↗MalfunctionDec 12, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2024 THE SCREWDRIVER WOULD NOT ALLOW RETENTION PIN TO BE INSERTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20918139 ↗MalfunctionDec 12, 2024Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT IT CAN NOT BE ASSEMBLED WITHOUT EXTREME FORCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20917458 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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