NA 393.10Recalls & reported problems
Synthes GmbH · UNIVERSAL CHUCK WITH T-HANDLE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes universal chuck with T-handle, a hand-held orthopedic instrument, has 116 adverse event reports on file. Many describe the handle or tip breaking or cracking, and some describe parts not fitting together. The reports include no deaths or injuries, and the number of reports fell from 14 to 4 over the last 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
- 116
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 10886982198983), received between Jan 12, 2017 and Aug 19, 2026 — classified as 116 malfunctions.
The most frequently reported specific device problem is “Break” (68 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
- Break68
- Device-Device Incompatibility41
- Material Deformation4
- Patient Device Interaction Problem3
- Device Slipped2
- Material Integrity Problem2
- Material Twisted/Bent2
- Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions75
- No Consequences Or Impact To Patient18
- No Patient Involvement16
- Insufficient Information8
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 116 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2026Device-Device Incompatibility; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50323047 ↗MalfunctionJun 9, 2026Break; Device Slipped
IT WAS REPORTED ON AN UNKNOWN DATE THE HANDLE OF THE DEVICE CAME APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447974 ↗MalfunctionNov 20, 2025Break; Break
IT WAS REPORTED THAT BROKEN T HANDLE CHUCK. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23606662 ↗MalfunctionNov 18, 2025Crack; Crack
IT WAS REPORTED ON (B)(6) 2025, TIP OF DEVICE IS CRACKED. NO OPERATION INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23582323 ↗MalfunctionSep 11, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE RATCHETING T HANDLE WAS DIFFICULT TO TIGHTEN. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23028174 ↗MalfunctionAug 7, 2025Break; Break
IT WAS REPORTED THAT UNIVERSAL CHUCK WITH T-HANDLE HAD CHIPPED/SMASHED EDGE. THERE WAS NO PATIENT INVOLVEMENT AND NO OPERATION WAS INVOLVED. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738784 ↗MalfunctionJul 8, 2025Break; Corroded; Break; Corroded
IT WAS REPORTED THAT ON (B)(6), 2025 THE DEVICE HAS PITTING/CHIPPING, ESPECIALLY ON TIP. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22438446 ↗MalfunctionJul 2, 2025Break; Break
IT WAS REPORTED THAT THE RELEASE MECHANISM BROKE OFF OF THE ITEM. NO OPERATION OR PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22381739 ↗MalfunctionJun 20, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTING THAT THE HOLDING POWER IS WEAK. AN UNREPAIRABLE LETTER WAS ISSUED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22302302 ↗MalfunctionJun 9, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON MAY 15, 2025, THE DEVICE WAS STUCK WITHIN HANDLE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22169568 ↗MalfunctionMay 12, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE SPD MANAGER HAD A BROKEN T HANDLED CHUCK. THE SURGEON MAY HAVE HIT TOO HARD WITH A MALLET. THE T HANDLE PORTION IS COMPLETELY SEPARATED FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22003249 ↗MalfunctionApr 24, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
ADDITIONAL INFORMATION WAS RECEIVED AND STATED AS FOLLOWS: - NO PATIENT INVOLVEMENT ITEM WORN DUE TO WEAR & TEAR. - NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21903471 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT THE UNIVERSAL T HANDLE CHUCK WAS FOUND BROKEN. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874570 ↗MalfunctionMar 25, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD A FRACTURED TIBIA, AND SURGEON CHOSE TO FIX WITH A TIBIA NAIL ADVANCED. INITIAL STEPS WERE COMPLETED WITHOUT INCIDENT. WHEN SURGEON WENT TO PUT DOWN BALL TIP GUIDEWIRE, THE T HANDLE CHUCK BROKE (393.10) ON THE BALL TIP GUIDEWIRE. ANOTHER BALL TIP GUIDEWIRE WAS OPENED ALONG WITH ANOTHER T HANDLE CHUCK. WHILE PUTTING THE SECOND BALL TIP GUIDEWIRE DOWN, THE SECOND T HANDLE CHUCK BROKE. SURGEON WAS ABLE TO REMOVE THE BROKEN T HANDLE FROM THE GUIDWIRE. A THIRD T HANDLE CHUCK WAS OPENED. SURGERY COMPLETED SUCCESSFULLY. THE SURGERY WAS 5 MINUTES DELAYED DUE TO THE REPORTED EVENT. ADDITIONAL INSTRUMENTS AND STERILE ITEMS WERE OPENED. THERE WAS PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: Insufficient Information
MAUDE report 21688926 ↗MalfunctionMar 25, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD A FRACTURED TIBIA, AND SURGEON CHOSE TO FIX WITH A TIBIA NAIL ADVANCED. INITIAL STEPS WERE COMPLETED WITHOUT INCIDENT. WHEN SURGEON WENT TO PUT DOWN BALL TIP GUIDEWIRE, THE T HANDLE CHUCK BROKE ON THE BALL TIP GUIDEWIRE. ANOTHER BALL TIP GUIDEWIRE WAS OPENED ALONG WITH ANOTHER T HANDLE CHUCK. WHILE PUTTING THE SECOND BALL TIP GUIDEWIRE DOWN, THE SECOND T HANDLE CHUCK BROKE. SURGEON WAS ABLE TO REMOVE THE BROKEN T HANDLE FROM THE GUIDEWIRE. A THIRD T HANDLE CHUCK WAS OPENED. SURGERY COMPLETED SUCCESSFULLY. THE SURGERY WAS 5 MINUTES DELAYED DUE TO THE REPORTED EVENT. ADDITIONAL INSTRUMENTS AND STERILE ITEMS WERE OPENED. THERE WAS PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: Insufficient Information
MAUDE report 21688919 ↗MalfunctionMar 10, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025, THE DEVICE WAS FOUND BROKEN IN STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21560793 ↗MalfunctionJan 27, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2024, ONE T HANDLE HAS A BENT HANDLE AND THE OTHER IS FALLING APART AND WON'T SCREW BACK TOGETHER. THERE WAS NO OPERATION INVOLVED/ NO PATIENT INVOLVEMENT AND NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21241972 ↗MalfunctionJan 27, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2024 ONE T HANDLE HAS A BENT HANDLE AND THE OTHER IS FALLING APART AND WON'T SCREW BACK TOGETHER. THERE WAS NO OPERATION INVOLVED/ NO PATIENT INVOLVEMENT AND NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21241933 ↗MalfunctionOct 28, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE HANDLES HAVE COME LOOSE DURING CLEANING OR SURGERY AT SOME POINT. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 20545776 ↗MalfunctionOct 28, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE HANDLES HAVE COME LOOSE DURING CLEANING OR SURGERY AT SOME POINT. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 20545482 ↗MalfunctionSep 18, 2024Break; Break
IT WAS REPORTED THAT ON SEP 05,2024 2 OF THE DEVICES ARE BADLY CHIPPED/SCORED AND THE OTHER 2 HAVE ISSUES CLOSING AND OPENING. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20245955 ↗MalfunctionSep 18, 2024Break; Break
IT WAS REPORTED THAT ON SEP 05,2024 TWO OF THE DEVICES ARE BADLY CHIPPED AND SCORED AND THE OTHER TWO HAVE ISSUES CLOSING AND OPENING. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20245884 ↗MalfunctionAug 29, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AUGUST 1, 2024 HANDLE SPINNING WITHOUT ENGAGING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20098777 ↗MalfunctionAug 23, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON JULY 29, 2024 THE ITEM WOULD NOT RELEASE AFTER BEING TIGHTENED DOWN. THIS WAS DISCOVERED DURING POST-INSPECTION. THERE WAS NO PATIENT INVOLVEMENT OR DELAY IN THE CASE. THIS REPORT IS FOR ONE (1) : UNIVERSAL CHUCK WITH T-HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20055724 ↗MalfunctionAug 23, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT ON JULY 24, 2024, THE T-HANDLES WERE SPINNING AND BENT. IT WAS ALSO NOTED THAT THE AWL WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20053893 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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