Arthrex® AR-8725-50HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867303485), received between Sep 18, 2019 and Sep 4, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Break; Break

  ON 08/15/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8725-50H COMPRESSION FT SCREW (FROM A LOANER SET) BROKE OFF INSIDE THE BONE DURING INSERTION. THE SCREW FRACTURED APPROXIMATELY ONE-THIRD OF THE WAY FROM THE HEAD, WITH ABOUT 35 MM EMBEDDED IN THE BONE. THE REMAINING PORTION OF THE SCREW WAS RETRIEVED, WHILE THE EMBEDDED FRAGMENT WAS LEFT IN THE BONE. A K-WIRE WAS SUBSEQUENTLY PLACED AT THE SITE. ADDITIONALLY, DURING THE PROCEDURE, THE AR-8738S COMPRESSION SCREW SET (ALSO FROM A LOANER SET) WAS FOUND TO BE MISSING AN AR-8737-61 SCREW REMOVER, EASY-OUT, 2.5 MICRO COMPRESSION FT, AND AN AR-8737-59 SCREW REMOVER, TREPHINE/EXTRACTOR, 2.5 MICRO/3.5 MINI CFT. DUE TO THE ABSENCE OF THESE TWO INSTRUMENTS, THE SCREW COULD NOT BE REMOVED. THE CASE WAS COMPLETED USING NON-ARTHREX K-WIRES TO STABILIZE THE FRACTURE. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 30 MINUTES, AND WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED IS UNCERTAIN. THIS OCCURRED DURING A METACARPAL FRACTURE PROCEDURE ON (B)(6) 2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 22962821 ↗
• InjuryNov 3, 2023Break; Break

  ON 10/04/2023, IT WAS REPORTED BY A PATIENT'S RELATIVE, VIA PHONE, THAT ON (B)(6) 2023 THE PATIENT UNDERWENT A METACARPAL FRACTURE SCREW FIXATION WHEN A SCREW SNAPPED IN HALF DURING INSERTION. THE SCREW HAD TO BE BURRED DOWN AS IT COULD NOT BE REMOVED. BURRING THE DEVICE DOWN RESULTED IN DEBRIS BEING PRODUCED. IT TOOK ABOUT AN HOUR TO IRRIGATE THE FRAGMENTS FROM THE PATIENT. THE PATIENT'S HAND HAD TO BE CUT OPEN TO CONTINUE WITH THE PROCEDURE RESULTING IN AN EXTENDED RECOVERY TIME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 10/05/2023. IT WAS REPORTED THAT AN AR-8725-50H MICRO COMPRESSION FT BROKE DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED VIA PHONE ON 10/31/2023: THE WIFE OF THE PATIENT ADVISED THAT THE FACILITY WILL NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE CASE. SHE HAS ASKED FOR THE SURGEON TO PROVIDE ALL THE PRODUCTS THAT WERE USED AND THEY ADVISED THIS INFORMATION IS NOT AVAILABLE. PER THE WIFE, THE SURGEON STATED THE ISSUE WAS WITH THE IMPLANT AND THAT A REVISION WILL NOT BE PERFORMED, AS THE SCREW CANNOT BE REMOVED BECAUSE THE PATIENT COULD EXPERIENCE LOSS OF BO

  Patient problems: Foreign Body In Patient

  MAUDE report 18067222 ↗
• MalfunctionNov 16, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-8725-50H MICRO COMPRESSION FT¿ SCREW, A AR-8737-45 DRIVER SHAFT, AND A AR-8737-37 DRIVER SHAFT BROKE. THIS OCCURRED DURING A METACARPAL SHAFT FRACTURE ON (B)(6) 2022 WHEN THE AR-8725-50H SCREW BROKE HALF WAY DURING IMPLANTATION INTO THE METACARPAL. ONCE THE SCREW WAS EXTRACTED AND THE OTHER SCREW WAS BEING IMPLANTED THE AR-8737-45, AND AR-8737-37 DRIVER SHAFTS ALSO BROKE. THE CASE WAS COMPLETED USING A METAL CUTTING BURR TO CUT THE REMAINING END OF THE SCREW OFF AND JUST BURR IT DOWN TILL IT WAS DOWN TO THE ARTICULAR SURFACE. ALL FRAGMENTS OF THE BROKEN DEVICES WERE RETRIEVED. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15803902 ↗
• MalfunctionJul 27, 2021Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A METACARPAL FRACTURE, BOTH 3.5 AND 2.5 HEADLESS SCREWS BROKE WHILE BEING IMPLANTED. WHEN SCREW WAS IMPLANTED AND GOING PAST THE ISTHMUS OF THE METACARPAL THE HEADLESS SCREW BROKE. THE SURGEON ATTEMPTED TO REMOVE THE SCREW USING THE DRIVER AND BROKE THE 1.5 HEX DRIVER. THEN HAD TO USE THE SYNTHES SCREW REMOVAL WHICH DIDNT WORK AS WELL AND RESORTED TO HAVING TO BURR DOWN THE SCREW FLUSH TO THE METACARPAL. ADDITIONAL INFORMATION PROVIDED 07/07/2021: THE LOT NUMBER OF THE SCREW'S WERE NOT LOCATED AS THE DEVICES WERE DISCARDED DURING THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12231519 ↗
• MalfunctionMar 30, 2021Break

  IT WAS REPORTED THAT DURING A FINGER FRACTURE REPAIR PROCEDURE, AS THE SURGEON WAS INSERTING THE AR-8725-50H, THE SCREW BROKE INSIDE THE BONE. THE SURGEON WAS ABLE TO REMOVE THE BROKEN SCREW BY OVER DRILLING THE INSERTION SIGHT. THE PROCEDURE WAS ADJUSTED WITH PROLONGED ANESTHESIA FOR 1/2 HOUR. THE CASE WAS COMPLETED USING COMPETITORS DEVICES.

  Patient problems: Failure of Implant

  MAUDE report 11590649 ↗
• InjuryJan 20, 2020Break

  IT WAS REPORTED BY THE SALES REP, THAT DURING A METATARSAL FRACTURE REPAIR PROCEDURE, THE SURGEON PREPARED THE INSERTION SITE USING A 2.2 DRILL, THE AR-8725-50H SCREW WAS INSERTED, AS THE SURGEON MADE THE FINAL TURNS, TO COUNTERSINK THE SCREW IT BROKE APPROXIMATELY 19-20 MM FROM THE DRIVE INSERTION POINT. THE SURGEON USED AN AR-8737-61, EASY OUT TOOL, ON POWER TO TRY AND RELEASE THE SCREW AND THE TIP OF THE DRIVER BROKE. THE PORTION OF THE SCREW WITH THE DRIVER INSERTION WAS REMOVED. THE REMAINDER OF THE SCREW WAS LEFT IN WITH THE TIP OF THE EASY OUT TOOL STILL IN THE CANNULATION OF THE SCREW. THE CASE WAS COMPLETED WITH THE REMAINDER OF THE SCREW STILL ACROSS THE FRACTURE SITE WITH THE FRACTURE REDUCED. ADDITIONAL INFORMATION OBTAINED 01/06/2020: THE SCREW BROKE BUT THE DRIVER FOR THE SCREW DID NOT BREAK. THE EXTRACTION TOOL BROKE LATER IN THE PROCEDURE. THE REMAINING 30 MM OF THE SCREW WAS LEFT IN THE PATIENT, STILL ACROSS THE FRACTURE SITE, WITH THE TIP OF THE EASY OUT TOOL IN THE SCREW'S CANNULATION. THE SURGEON DID NOT NEED TO USE ANY ADDITIONAL SCREWS OR ADDITIONAL INCISIONS. IT WAS A METACARPAL FRACTURE AND THERE WERE LIMITED ACCESS POINTS. THE SURGEON DID NOT NEED TO DO ANY

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9607409 ↗
• InjurySep 18, 2019Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A RIGHT HAND ARTHROSCOPY PROCEDURE, THE SURGEON WAS INSERTING A MICRO COMPRESSION SCREW, AR-8725-50H, WITH A 1.5 MM HEX DRIVER, AR-8737-37. UPON INSERTING INTO THE 4TH METACARPAL, THE TIP OF THE HEX DRIVER BROKE OFF INTO THE HEAD OF THE COMPRESSION SCREW AND THE SCREW BENT. THE SCREW WAS REMOVED AND THE SURGEON PLACED A SYNTHES PLATE INSTEAD. THE TIP OF THE DRIVER WAS REMOVED FROM THE HEAD AND FELL ONTO THE FLOOR. THE SURGEON MOVED ON THE NEXT STEP AND TRIED AGAIN WITH A SECOND MICRO COMPRESSION SCREW, AR-8725-50H, AND DRIVER. THE SURGEON STARTED ON POWER WITH THE DRIVER ON THE END OF IT AND THEN FINISHED UP WITH A RATCHETING HANDLE. UPON INSERTION OF THIS SCREW INTO THE 3RD METACARPAL, ABOUT 8 MM OF THE HEAD OF THE SCREW SNAPPED OFF LEAVING APROX. 42 MM OF THE SCREW IN THE TUNNEL. THIS PORTION OF THE SCREW WAS NOT REMOVED FROM THE TUNNEL. THE SURGEON WAS NOT SATISFIED WITH THE FIXATION AND USED A SYNTHES SCREW TO LAG ACROSS THE FRACTURE SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9081390 ↗