BIOSYNC EVANS WEDGE, 20 X 20 X 6.5 MM

Description of Event or Problem

ON (B)(6) 2021, IT WAS REPORTED BY A LEGAL REPRESENTATIVE VIA EMAIL THAT A PATIENT HAD A RIGHT ANKLE RECONSTRUCTION SURGERY WHICH OCCURRED IN (B)(6) ON (B)(6) 2017. DURING SURGERY, AN ARTHREX EVANS BIOSYNC WEDGE WAS PLACED INSIDE THE ANKLE; HOWEVER, THE EXACT MATERIAL AND BATCH NUMBER ARE UNKNOWN AT THIS TIME. THE SURGERY WAS WITHOUT COMPLICATION AND PATIENT HAD A NORMAL COURSE OF TREATMENT AND RECOVERY POST-OPERATIVELY. IN (B)(6) 2020, PATIENT BEGAN TO EXPERIENCE PERSISTENT PAIN TO HER RIGHT ANKLE AND UNDER WENT A REVISION SURGERY ON (B)(6) 2021 TO REMOVE THE HARDWARE. DURING THE PROCEDURE, SURGEON FOUND MULTIPLE METAL FRAGMENTS EMBEDDED IN THE PATIENT'S TENDON. FURTHER, SURGEON ALSO FOUND THAT THE ANTERIOR PROCESS WAS AVASCULAR, DISINTEGRATING, AND THAT THERE WAS SUBSIDENCE OF THE ARTHREX METALLIC WEDGE. ADDITIONAL INFORMATION RECEIVED 12/2/2021: DEVICE PART NUMBER IS AR-8942W-2006 BIOSYNC EVANS WEDGE FROM BATCH NUMBER 4211.

Additional Manufacturer Narrative

THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

COMPLAINT CONFIRMED. VISUAL EVALUATION IDENTIFIED THAT THE PART HAD FRACTURED INTO SEVERAL PIECES. HOWEVER, WITHOUT THE RETURN OF THE DEVICE, FURTHER INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE OF THE REPORTED FAILURE MODE IS UNDETERMINED.