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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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