NA 511.776Recalls & reported problems
Synthes GmbH · TORQUE LIMITING ATTACHMENT 0.8NM/QUICK COUPLING · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982237866), received between May 20, 2022 and Dec 17, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Contamination /Decontamination Problem1
- Device-Device Incompatibility1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2025Material Integrity Problem; Material Integrity Problem
THERE WAS A DAMAGED TORQUE LIMITER. IT WAS DAMAGED FROM LAST USE IN THEATRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827789 ↗MalfunctionSep 30, 2024Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH RHP FOR THE PROXIMAL RADIUS FRACTURE. WHEN INSERTING A LOCKING FOR FINAL LOCKING SCREW AFTER INSTALLATION OF THE PLATE, THE TORQUE LIMITING ATTACHMENT BROKE. SOFT TISSUE-LIKE SUBSTANCE WAS OBSERVED INSIDE THE INSTRUMENT. THE SURGERY WAS COMPLETED USING AN ALTERNATIVE PRODUCT. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT WAS REPORTED AS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20334251 ↗MalfunctionMay 20, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON UNKNOWN DATE, IN STERILE PROCESSING DEPARTMENT (SPD), THE NOZZLE OF ONE (1) TORQUE LIMITER COULD NOT BE PULLED BACK. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A TORQUE LIMITER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14454540 ↗
Other MOTOR, SURGICAL INSTRUMENT, AC-POWERED devices
- NA 05.001.201Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,902 reports
- NA 530.710Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,800 reports
- NA 530.705Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,492 reports
- NA 530.715Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED390 reports
- NA 530.730Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED267 reports
- NA 05.001.240Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED262 reports
- KINCISE™ 1000-00-101Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED242 reports
- NA 530.791Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED84 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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