MAUDE Adverse Event Report: ARTHREX, INC. Ø7X 20MM PEEK IF SCRW NON-VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	Ø7X 20MM PEEK IF SCRW NON-VENTED
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2021, it was reported by a facility representative via e-mail that a ar-4020p-07 fastthread broke.This occurred on 11/23/2021 during a btb autograft acl reconstruction.Once the graft passed the pencil dilator was used and then the peek fast thread screw was brought in.The screw broke in half while being screwed in.All broken fragments were retrieved, and the procedure was completed successfully using a ar-1370e.The patient had hard bone quality.There was no effect to the patient reported.Additional information requested.Additional information provided on 11/24/2021 : the bone was prepped using 2.4 pin from ar-1898s, followed by 1409lp, then ar-1845 notcher, after graft passed 1.1 nitinol wire placed ar-1377c-07 dilator used then screw placed over nitinol wire.

• Brand Name: Ø7X 20MM PEEK IF SCRW NON-VENTED
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 13471083
• Report Number: 1220246-2022-04394
• Device Sequence Number: 16572452
• Product Code: MAI
• UDI-Device Identifier: 00888867295001
• UDI-Public: 00888867295001
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K180662
• 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): 02/07/2022

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 Expiration Date: 12/31/2025
• Device Model Number: Ø7X 20MM PEEK IF SCRW NON-VENTED
• Device Catalogue Number: AR-4020P-07
• Device Lot Number: 12492527
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 02/07/2022
• Date Device Manufactured: 01/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown