Arthrex® AR-1662BC-9Recalls & reported problems
Arthrex, Inc. · SWVLK TENO BIO-COMP 9X 19.5MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867020597), received between Aug 6, 2026 and Aug 6, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Nerve Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2026Patient Device Interaction Problem
On 16-Jul-26, Arthrex was notified of a case report published in JSES Reviews, Reports, and Techniques by Pellicer-Garcia et¿al., conducted at General University Hospital Virgin of the Lilies, Alcoy, Spain. The publication reports a case of simultaneous musculocutaneous nerve entrapment and radial nerve traction injury following open subpectoral biceps tenodesis using an Arthrex BioComposite SwiveLock 9 × 19.5 mm. Immediately following surgery, the patient exhibited weak elbow flexion, complete paralysis of wrist and finger extension, weak supination, and sensory loss consistent with combined musculocutaneous and radial nerve palsy. Ultrasound and revision surgery confirmed entrapment and compression of the musculocutaneous nerve beneath the tenodesed tendon. Revision surgery was performed, including removal of the interference screw, reversal of the tenodesis, and neurolysis of the musculocutaneous nerve. The patient experienced progressive neurological recovery and had resumed almost normal daily activities approximately one year after the initial surgery.
Patient problems: Nerve Damage
MAUDE report 50155979 ↗
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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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