MAUDE Adverse Event Report: ARTHREX, INC. BIOSYNC EVANS WEDGE, 20 X 20 X 6.5 MM; BONE WEDGE

Model Number	BIOSYNC EVANS WEDGE, 20 X 20 X
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: BIOSYNC EVANS WEDGE, 20 X 20 X 6.5 MM
• Common Device Name: BONE WEDGE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13060625
• Report Number: 1220246-2021-04159
• Device Sequence Number: 3888474
• Product Code: PLF
• UDI-Device Identifier: 00888867202801
• UDI-Public: 00888867202801
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BIOSYNC EVANS WEDGE, 20 X 20 X
• Device Catalogue Number: AR-8942W-2006
• Device Lot Number: 4211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown