Arthrex® AR-8925SS-01Recalls & reported problems
Arthrex, Inc. · K-LESS T-ROPE W/DRV IMP ONLY,SYN REPR,SS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867380028), received between Apr 23, 2025 and Apr 23, 2025 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2025Break; Break
IT WAS REPORTED THAT DURING A SYNDESMOSIS REFIXATION SURGERY THE DEVICE TORE NEAR THE MEDIAL BUTTON DURING TIGHTENING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21891448 ↗
Other WASHER, BOLT NUT devices
- FIBULINK FGS-1000Synthes GmbH · Washer, Bolt Nut117 reports
- Arthrex® AR-2372BLOArthrex, Inc. · WASHER, BOLT NUT91 reports
- Arthrex® AR-8925SSArthrex, Inc. · WASHER, BOLT NUT79 reports
- Arthrex® AR-8925TArthrex, Inc. · WASHER, BOLT NUT71 reports
- Arthrex® AR-8926TArthrex, Inc. · WASHER, BOLT NUT61 reports
- RipCord STA001KTrimed, INC. · WASHER, BOLT NUT1 recall2 reports
- Arthrex® AR-7000-18TArthrex, Inc. · WASHER, BOLT NUT1 recall0 reports
- Arthrex® AR-8926SSArthrex, Inc. · WASHER, BOLT NUT35 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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