Arthrex® AR-7229-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867041608), received between Apr 18, 2018 and Aug 14, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2024Material Frayed; Material Frayed

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-7229-20 FIBERLOOP WAS FRAYED. THIS WAS DISCOVERED UPON OPENING THE PACKAGE DURING A PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING ANOTHER AR-7229-20 FIBERLOOP.

  Patient problems: Insufficient Information

  MAUDE report 19987985 ↗
• InjuryApr 18, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT PATIENT HAD PRIOR SURGERY WHICH RESULTED IN A PATIENT REACTION TO THE SUTURES THAT WERE USED. THE PRIOR SURGERY WAS ON (B)(6) 2017. IT WAS A LEFT THUMB CMC ARTHROPLASTY. SUTURES USED IN THE PRIOR SURGERY WERE ULNAR CAPSULE SUTURE 4-0 SUPRAMID (S. JACKSON) AND SUBCUTICULAR SUTURE 4-0 PROLENE (J&J). NO ARTHREX PRODUCTS WERE USED DURING THIS PRIOR SURGERY. REACTION SYMPTOMS BEGAN WITHIN 7-10 DAYS OF PRIOR SURGERY. REACTION WAS INFLAMMATION, HEAT AND A BURNING FEELING. NO PAIN WAS INVOLVED IN THE REACTION FROM THIS PRIOR SURGERY. PATIENT WAS PUT ON ANTIBIOTICS AS A PRECAUTION, BUT SYMPTOMS SUBSIDED UPON REMOVING THE SUTURES AT 14 DAYS POST OP. AROUND 7 MONTHS POST JOINT REPLACEMENT PATIENT BEGAN HAVING PAIN IN THE JOINT. AT THAT TIME IT WAS DETERMINED PATIENT HAD A PROMINENT OSTEOPHYTE AND POTENTIAL FCR TENDONITIS. SURGERY WAS SCHEDULED AND PERFORMED (B)(6) 2018, 11 MONTHS AFTER THE PRIOR SURGERY THAT RESULTED IN A REACTION TO THE SUTURES. THE SECOND SURGERY WAS A LEFT THUMB TRAPEZIAL OSTEOPHYTE REACTION AND LEFT THUMB FCR TENOTOMY. PATIENT RECEIVED ANOTHER MANUFACTURER'S IMPLANT (SKELETAL DYNAMICS) DURING THE (B)(6) 2018 SURGERY. SUTURES USED DURING THE (B)(6) 201

  Patient problems: Burning Sensation; Inflammation; Pain; Reaction

  MAUDE report 7439304 ↗