Arthrex® AR-8725-30HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867126930), received between Jul 17, 2018 and Jun 27, 2024 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2024Material Fragmentation; Material Fragmentation

  ON 06/06/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-8725-30H MICRO COMPRESSION FT SCREW HAD FLECKS OF SOMETHING COMING OFF OF THE HEAD. THIS OCCURRED DURING A CASE AND THERE WERE ALSO PARTS OF THE THREADING THAT HAD BUILT-UP AND THEY WEREN'T ABLE TO REMOVE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624175 ↗
• InjuryJan 18, 2021Material Fragmentation

  IT WAS REPORTED, THAT DURING A DIP FUSION AS THE SURGEON WAS INSERTING THE AR-8725-30H SCREW INTO THE DRILLED TUNNEL 1/2 OF THE SCREW HEAD BROKE OFF. THE CASE WAS COMPLETED BY LEAVING THE BROKEN SCREW IN THE TUNNEL WITH HALF A SCREW HEAD.

  Patient problems: Foreign Body In Patient

  MAUDE report 11186505 ↗
• InjurySep 25, 2019Break; Material Protrusion/Extrusion; Physical Resistance/Sticking

  IT WAS REPORTED DURING A REVISION SCREW REMOVAL PROCEDURE, AS THE SURGEON WAS CORING OUT THE BONE AROUND THE IMPLANTED 2.5 HEADLESS COMPRESSION SCREW, THE HEAD OF THE SCREW BROKE OFF AND BECAME STUCK INSIDE OF THE AR-8737-59 SCREW EXTRACTOR/TREPHINE. THE SCREW BROKE OFF FLUSH BELOW THE CORTEX, AND THE BODY OF THE SCREW WAS LEFT IMPLANTED IN THE BONE. THE REP STATED THE PRIMARY PROCEDURE TOOK PLACE APPROXIMATELY 2-3 YEARS AGO. THE REASON FOR THE REVISION WAS DUE TO THE SCREW PROTRUDING 2-3MM OUT OF THE BONE. THE PROTRUDING SCREW WAS CAUSING PAIN AND DISCOMFORT FOR THE PATIENT. THE PRIMARY PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON. THE REP CONFIRMED THE AR-8737-59 AND BROKEN SCREW HEAD WILL BE RETURNING FOR EVALUATION. THE REP STATED THEY CURRENTLY DO NOT HAVE ANY ADDITIONAL DETAILS REGARDING THE PRIMARY PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 07/30/2019: THE REP STATED THE PRIMARY PROCEDURE WAS A MTP FUSION PROCEDURE, AND THE PART AND LOT NUMBERS OF ARTHREX DEVICES IMPLANTED DURING THE PRIMARY PROCEDURE ARE UNKNOWN. THE REP REPORTED THE PART AND LOT NUMBER OF THE 2.5 HEADLESS COMPRESSION SCREW THAT THE SURGEON WAS ATTEMPTING TO EXPLANT DURING THE REVISION PROCEDURE IS UNK

  Patient problems: Discomfort; Pain

  MAUDE report 9119561 ↗
• InjuryJul 17, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HAND PROCEDURE, THE TIP OF THE DRIVER, AR-8737-37 BROKE OFF INTO THE AR-8725-30H UPON IMPLANTATION. DESPITE VARYING ATTEMPTS, THE TIP OF THE DRIVER COULD NOT BE REMOVED AND THE PORTION OF THE SCREW THAT WAS REMAINING OUTSIDE OF DISTAL PHALANX WAS CUT OFF WITH WIRE CUTTER. A SECOND SURGERY IS NOT NECESSARY IN THIS CASE. ADDITIONAL INFORMATION OBTAINED: THE CASE WAS AN IP FUSION. THE CASE WAS COMPLETED WITH THE SURGEON CUTTING OFF THE REMAINING DISTAL END OF THE SCREW THAT WAS STILL OUTSIDE OF THE PHALANX. X-RAYS WERE TAKEN, HOWEVER, REP DOES NOT HAVE COPIES OF THESE. SHE WILL REACH OUT TO THE SURGERY CENTER TO SEE IF SHE CAN GET A COPY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7693336 ↗