MAUDE Adverse Event Report: ARTHREX, INC. BIOSYNC WEDGE INSTRUMENTATION SET; MANUAL INSTR, GENERAL SURGICAL

Model Number	BIOSYNC WEDGE INSTRUMENTATION SET
Medical Device Problem Code	Pitted (1460)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.A total of twenty instruments from an ar-8948s instrument set were received for investigation.Visual inspection identified the presence of heavy corrosion across the metallic components of the device.A review of device history records associated with the returned part/lot combinations revealed that on average, the returned devices were manufactured between 2016-2017.The most likely cause can be attributed to wear and tear incurred as a result of repeated cleaning cycles.
Event or Problem Description
It was reported, the sales rep, noticed that all the handles unscrew from the trail wedge pieces.The sales rep brought the tray back to the distributors office and many of the threads have what appeared to be almost corrosive characteristics embedded in the threads and it appeared as if these trials hadn¿t been removed from their respective handles in years.

• Brand Name: BIOSYNC WEDGE INSTRUMENTATION SET
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: jared engle ; 8009337001
• MDR Report Key: 19564194
• Report Number: 1220246-2024-06048
• Device Sequence Number: 6112627
• Product Code: MDM
• UDI-Device Identifier: 00888867217478
• UDI-Public: 00888867217478
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BIOSYNC WEDGE INSTRUMENTATION SET
• Device Catalogue Number: AR-8948S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown