MAUDE Adverse Event Report: ARTHREX, INC. BIOSYNC EVANS WEDGE, 18 X 18 X 6.5 MM; BONE WEDGE

Model Number	BIOSYNC EVANS WEDGE, 18 X 18 X 6.5 MM
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a patient had an initial distal extremity evans osteotomy surgery (b)(6) 2019 using an ar-8942-1809 (lot 4266), biosync evans wedge 18 x 18 x 6.5.The patient was complaining about new foot pain with no report of any traumatic event.Patient woke up one morning with a good deal of pain in their previously operated on foot.(b)(6) 2020 the patient underwent a second surgery.After dissection it was notice instantly that the biosync evan wedge was broken.It was fragmented into four separate pieces, only being held in place by it's screws.Surgeon relayed to the sales rep that he was shocked that this issue occurred, adding that he had never seen one break before.The device will not be returned as the facility kept it for pathology.Additional information obtained 11/17/20: to removed the biosync evans wedge the two original implanted screws also had to be explanted.The two screws were as follows: low profile screw, 2.4 x 20mm, cortex (ar-8724-20, lot # 193349), low profile screw, 2.4 x 24mm, cortex (ar-8724-24, lot #199124).The revision procedure was completed with a lifenet iliac crest wedge and the following arthrex products.Ar-8952xm, x-plate, medium 3.0mm, lot 5261727, ar-8933v-22, 3.0 x 22mm val screw, lot 4455693, ar-8933v-24, 3.0 x 24mm val screw, lot 031838, ar-8933v-26.3.0 x 26mm val screw, lot 031834.

• Brand Name: BIOSYNC EVANS WEDGE, 18 X 18 X 6.5 MM
• Common Device Name: BONE WEDGE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10958399
• Report Number: 1220246-2020-02391
• Device Sequence Number: 16931412
• Product Code: PLF
• UDI-Device Identifier: 00888867202764
• UDI-Public: 00888867202764
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2020

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 Expiration Date: 10/31/2021
• Device Model Number: BIOSYNC EVANS WEDGE, 18 X 18 X 6.5 MM
• Device Catalogue Number: AR-8942W-1806
• Device Lot Number: 4266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/07/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other