Arthrex® AR-8737-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867197787), received between Sep 2, 2020 and Jun 11, 2024 — classified as 1 injury, 6 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 16, 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.

• MalfunctionJun 11, 2024Break; Break

  DURING THE CASE THE TIP OF THE DRIVER WAS BROKEN AND REMAINED IN THE SCREW. ALL WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19514820 ↗
• 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 15803919 ↗
• MalfunctionJul 11, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-8737-37 DRIVER SHAFT AND ONE AR-8737-45 DRIVER SHAFT BROKEN TRYING TO REMOVE A SCREW. THIS WAS DISCOVERED DURING AN SCAPHOID FRAGMENT ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14976046 ↗
• MalfunctionJul 27, 2021Break

  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 DIDN¿T WORK AS WELL AND RESORTED TO HAVING TO BURR DOWN THE SCREW FLUSH TO THE METACARPAL. ADDITIONAL INFORMATION PROVIDED 7/7/21: THE LOT NUMBER OF THE SCREW'S WERE NOT LOCATED AS THE DEVICES WERE DISCARDED DURING THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12231517 ↗
• MalfunctionMar 31, 2021Break

  IT WAS REPORTED THAT THE TIP OF THE AR-8737-37 BROKE OFF IN THE SCREW DURING IMPLANT. THE TIP WAS REMOVED FROM THE IMPLANT. THEY THEN USED AN AR-8737-45 TO COMPLETE THE IMPLANT; THAT TIP ALSO BROKE OFF IN THE IMPLANT AND IT WAS REMOVED. THIS WAS A HAMMERTOE CASE.

  Patient problems: Failure of Implant

  MAUDE report 11599546 ↗
• MalfunctionFeb 1, 2021Break

  IT WAS REPORTED THAT THE SURGEON WAS INSERTING A 2.5MM MICRO COMPRESSION FT SCREW FOR A FOUR CORNER FUSION. THE AR-8737-37 CANNULATED DRIVER BROKE TOWARDS THE END OF THE SCREW BEING INSERTED. THE SURGEON THEN TRIED WITH THE AR-8737-45 SOLID DRIVER AND IT STRIPPED.

  Patient problems: Failure of Implant

  MAUDE report 11259202 ↗
• InjurySep 2, 2020Break

  IT WAS REPORTED THAT DURING AN (B)(6) 2020 HAMMERTOE PROCEDURE WAS PERFORMED USING ARTHREX AR-8725-XXH COMPRESSION FT SCREWS. UPON INSERTION OF THE HEADLESS SCREWS, TWO OF THE CANNULATED 1.5MM HEX DRIVERS (AR-8737-37) AND ONE 1.5MM SOLID DRIVER (AR-8737-45) BROKE. STANDARD TECHNIQUE WAS USED TO INSERT THE HEADLESS COMPRESSION SCREWS. AS THE NEAR END OF THE HEADLESS CREW WAS ROUGHLY 3 MM FROM CROSSING THE DIP JOINT, THE PORTION OF THE CANNULATED DRIVER ENGAGED WITH THE HEADLESS CREW BROKE. THE SURGEON WAS ATTEMPTING TO ONLY FUSE THE PIP JOINT OF THE 2ND TOE. HE WAS ABLE TO REMOVE THE BROKEN CANNULATED DRIVER PORTION FROM THE HEAD OF THE SCREW AND RE-ENGAGE A SECOND CANNULATED DRIVER. THE SECOND DRIVER AGAIN BROKE IN THE SAME FASHION AS THE FIRST, EXCEPT THIS TIME THE SURGEON WAS ATTEMPTING TO BACK THE SCREW OUT. A THIRD DRIVER, A SOLID 1.5 HEX, WAS THEN USED WHICH ALSO SUBSEQUENTLY BROKE. THE SURGEON THEN ATTEMPTED TO MALLET THE SCREW ACROSS THE DIP JOINT TO NO AVAIL. THE SCREW WAS LEFT CROSSING BOTH THE PIP AND DIP JOINTS AND THUS ALTERING THE END RESULT OF THE CASE. PICTURES HAVE BEEN PROVIDED TO ARTHREX AND ATTACHED TO THE FILE. ADDITIONAL INFORMATION OBTAINED 8/19/2020: THERE WE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10482226 ↗