Arthrex® AR-8735BV-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867360822), received between Dec 3, 2024 and Sep 4, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

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.

• MalfunctionSep 4, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, A FACILITY REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8735BV-38 BEVELED FT SCREW WAS FOUND TO BE PROMINENTLY POSITIONED IN THE MCP JOINT SPACE. SURGICAL REMOVAL IS PLANNED FOR THE END OF (B)(6). THIS ISSUE WAS IDENTIFIED POST-IMPLEMENTATION, WITH NO ADDITIONAL DETAILS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 08/26/2025: THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION WITH AN INTRAMEDULLARY SCREW FOR A RIGHT FIFTH METACARPAL NECK FRACTURE WITH SIGNIFICANT DISPLACEMENT ON (B)(6) 2025. THE ARTHREX PRODUCT IMPLANTED DURING THE PROCEDURE WAS THE AR-8735BV-38 BEVELED FT SCREW (3.5 MM X 38 MM). DURING THE PROCEDURE, THE SURGEON NOTED THAT THE SCREW HAD BEEN STRIPPED AND SUBSEQUENTLY BURRED DOWN THE PROMINENT PORTION. FINAL INTRAOPERATIVE X-RAYS CONFIRMED THAT THE SCREW WAS BURIED BENEATH THE ARTICULAR CARTILAGE. THE SURGEON THEN ASSESSED THE SMALL FINGER MCP JOINT THROUGH ITS RANGE OF MOTION. THE FRACTURE WAS STABILIZED, AND THERE WAS NO EVIDENCE OF IMPINGEMENT FROM THE IMPLANT. SCREW PROMINENCE WAS FIRST IDENTIFIED VIA X-RAY IMAGING AT THE PATIENT'S ROUTINE FOUR-WEEK FOLLOW-UP VISIT ON (B)(6) 2025 (SEE ATTACHMENT). DURING THIS APPOINTMENT, THE PATIENT

  Patient problems: Foreign Body In Patient

  MAUDE report 22962444 ↗
• MalfunctionDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED ON 12/16/2024: THE TWO PROTRUDING SCREWS ARE IN THE THIRD AND FOURTH METACARPALS. A REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 20835329 ↗