Arthrex® AR-8737-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867046207), received between Oct 4, 2021 and May 8, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT DURING A SCREW REMOVAL SURGERY THE DEVICE BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE RETIREVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 07-MAY-2024: IT WAS CONFIRMED THAT THE DISTAL PART OF THE SCREW DRIVER BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270893 ↗
• MalfunctionJun 12, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-16 AND AN AR-8737-25 , 2.4 AND 3.0 CANNULATED DRIVERS BROKE DURING A CASE DUE TO WEAR AND TEAR. PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17112386 ↗
• MalfunctionAug 18, 2022Break

  IT WAS REPORTED THAT DURING A SURGERY FOUR DRIVERS BROKE DURING REMOVAL OF THE SCREW. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. UPDATE (B)(6) 2022: REMOVAL OF PLATE AND SCREWS WAS PERFORMED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD-PARTY. ANOTHER SCREW DRIVER WAS USED TO FINISH THE SURGERY SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE (B)(6) 2022: THE PART AND LOT NUMBERS OF BROKEN DRIVERS WERE RECEIVED: AR-8610D-25, LOT 6045184103. AR-8737-25, LOT 01391809. AR-8610D-30, LOT (10)1392150. AR-8737-26, LOT (10)1392118.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15249419 ↗
• MalfunctionOct 4, 2021Break

  IT WAS REPORTED THAT DURING SURGERY/ TREATMENT THE SCREWDRIVER DID BREAK OFF WHILE A SIMPLE METAL REMOVAL. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY, THE SCREW HAS BEEN TAKEN OFF WITH A BIGGER DRILL AND A PLIER, BECAUSE OF THE CHANCE OF THE SURGICAL TECHNIQUE THE TIME OF THE SURGERY WAS EXTENDED WITH 40 ADDITIONAL MINUTES. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12570775 ↗