MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLES KIT, FOR DX FIBERTAK; POWERED SURG ORTHOPEDIC INSTR

Model Number	DISPOSABLES KIT, FOR DX FIBERTAK
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during surgery the k-1 wire drill within the ar-8990ds bent.The procedure was completed without issue after re-drilling with new kit and anchor.The rep reported the devices did not break into discrete pieces.The suture on the anchor unloaded and was pierced by the forked tip of the anchor rendering it unusable.
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.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the reported event is not confirmed without the device being returned or any photos provided.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: DISPOSABLES KIT, FOR DX FIBERTAK
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 19357748
• Report Number: 1220246-2024-03558
• Device Sequence Number: 11711847
• Product Code: HWE
• UDI-Device Identifier: 00888867264984
• UDI-Public: 00888867264984
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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: DISPOSABLES KIT, FOR DX FIBERTAK
• Device Catalogue Number: AR-8990DS
• Device Lot Number: 12227072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown