Arthrex® AR-8545-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867124608), received between Sep 7, 2016 and Feb 25, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT HAD SUSTAINED A WORK INJURY ON (B)(6) 2019, INJURING A VARIETY OF BODY PARTS IN THAT FALL. PATIENT SUSTAINED INJURIES TO HIS RIGHT LOWER EXTREMITY. SINCE THE INJURY THE PATIENT HAS UNDERGONE SEVERAL PROCEDURES ON HIS RIGHT LOWER EXTREMITY. ON (B)(6) 2019: EXTERNAL FIXATOR IMPLANTED. AT SOME POINT AFTER THE INITIAL SURGICAL PROCEDURE ON (B)(6) 2019, PATIENT'S RIGHT LOWER EXTREMITY BECAME SEVERELY INFECTED. ON (B)(6) 2019: EXTERNAL FIXATOR REMOVED AND ORIF CONDUCTED ON RIGHT TIBIAL PILON. THE PRODUCT IMPLANTED IN THE PATIENT DURING THE (B)(6) PROCEDURES WERE ANOTHER MANUFACTURER'S PRODUCT (NON-ARTHREX). (B)(6) 2019: IRRIGATION AND DEBRIDEMENT, HARDWARE REMOVAL, INSERTION OF ANTIBIOTIC BEADS AND SPACER. (B)(6), 2019: IRRIGATION AND DEBRIDEMENT, RE-INSERTION OF ANTIBIOTIC BEADS AND SPACER. (B)(6) 2019: DEBRIDEMENT AND PREPARATION OF WOUND, SKIN TRANSFER FROM RIGHT THIGH, EXCHANGE OF ANTIBIOTIC SPACER. PATIENT WAS TREATED FOR INFECTION AFTER THE (B)(6) 2019 PROCEDURES UNTIL JUST PRIOR TO THE (B)(6) 2019 PROCEDURE WHERE ARTHREX PRODUCTS WERE IMPLANTED. (B)(6) 2019: IRRIGATION AND DEBRIDEMENT, ANTIBIOTIC SPACER EXCHANG

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9751152 ↗
• InjurySep 7, 2016Break; Device Slipped

  IT WAS REPORTED THAT AN ANKLE FUSION PLATE, ANTERIOR TT, RIGHT, AR-8970AR, LOT 6791439, WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2015. BY THE THIRD FOLLOW UP VISIT POST-OP, THE HEALTH CARE PROVIDER NOTICED THE DISTAL LOCKING SCREWS IN THE TALUS WERE BROKEN AND BEGAN TO LOOSEN. ON (B)(6) 2016, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE BROKEN SCREWS AR-8545L-40 LOT UNKNOWN ((B)(4) (B)(6)), AR-8545-38 LOT UNKNOWN ((B)(4) (B)(6)) AND AR-8555-60 LOT UNKNOWN ((B)(4) (B)(6)) WERE REMOVED. THE SCREWS ARE BEING RETURNED FOR EVALUATION. ALSO EXPLANTED WERE THE ANKLE FUSION PLATE, ANTERIOR TT, RIGHT AND THE REMAINING SCREWS ALL OF WHICH HAD NO ISSUE. THESE ARE ALSO BEING RETURNED WITH THE BROKEN SCREWS. THE SURGEON USED ANOTHER MANUFACTURER'S ANKLE FUSION DEVICE AND BIOLOGICS FOR THE REVISION. THE SURGERY OUTCOME IS UNKNOWN AT THIS TIME. THE SURGEON SUSPECTS THE LOCKING MECHANISM MAY NOT HAVE PERFORMED AS EXPECTED. THE SURGEON ALSO POINTS TOWARD JOINT PREPARATION AND LACK OF POSTERIOR FIXATION AS MODE OF IMPLANT FAILURE.

  Patient problems: No Code Available

  MAUDE report 5933841 ↗