Arthrex® AR-8735-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867288324), received between May 17, 2018 and Jun 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• InjuryJun 26, 2019Break

  IT WAS REPORTED THAT DURING A CASE, THE SURGEON WAS INSERTING THE TITANIUM 3.5 CORTICAL LOW PROFILE SCREW, AR-8735-16, THROUGH THE COMPRESSION SLOT OF A 6-HOLE TITANIUM RECONSTRUCTION PLATE. AS HE REACHED THE FAR CORTEX, HE CONTINUED TO TRY AND GAIN ADDITIONAL COMPRESSION WHEN THE HEAD OF THE SCREW BROKE FROM THE SHAFT OF THE SCREW. THE HEAD OF THE SCREW WAS RETRIEVED BUT THE SCREW IS STILL IN THE PATIENT STUCK WITHIN THE CORTICES OF BONE. PATIENT IS A MALE, (B)(6). ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 6/6/2019: THIS OCCURRED DURING A RADIAL SHAFT FRACTURE AND THE HEAD OF THE SCREW WAS REMOVED IN DEFAULT OF COMPRESSING THE PLATE TO BONE. THE PATIENT WAS (B)(6) WITH CONSEQUENTIALLY STRONG CORTICAL BONE IN THE RADIUS. REP DOES NOT HAVE X-RAYS BUT THE SCREW SHAFT WAS LEFT IN THE PROXIMAL ASPECT OF THE OBLONG SLOT OF A 6-HOLE TITANIUM RECONSTRUCTION PLATE. NO GRAFT WAS BEING USED IN THIS PLATING CONSTRUCT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8734556 ↗
• InjuryMay 17, 2018Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A DISTAL RADIUS PROCEDURE, UPON INSERTION OF THE VERY FIRST 3.5 MM LOW PROFILE CORTICAL SCREW, THIS SCREW HEAD CAME OFF. THE HEAD OF THE SCREW WAS RETRIEVED HOWEVER, THE BODY OF THE SCREW WAS UNABLE TO BE REMOVED. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. FOLLOW-UP INVESTIGATION: THE SURGEON ATTEMPTED TO REMOVE THE BODY OF THE SCREW WITH THE DRIVER INITIALLY BUT WITH NO SUCCESS, HE SWITCHED TO A NEEDLE DRIVER. STILL, THE BODY OF THE SCREW COULD NOT BE REMOVED AND WAS LEFT IN THE PATIENT SITTING FLUSH WITH THE BONE. 5. THE CASE WAS COMPLETED WITH A 3.5 SIZE 14 LOCKING SCREW PROXIMALLY AND A 3.5 CORTICAL SCREW SIZE 14 IN THE 3 HOLE PLATE. IN THE DISTAL PORTION, THE PLATE WAS FILLED WITH 2.4 VAL SCREWS SIZES 16, 18, 18, AND 20.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7521501 ↗