MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPR INTERF SCRW,FULL THD; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMPR INTERF SCRW,FULL THD
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/24/2022, it was reported by an arthrex employee via email that an ar-1390tc full thread cannulated biocomposite interference screw does not seat well, leaving the ligament repair unstable.Surgeon also noticed that one of the threads on the screw were flat.Another screw is opened and case is completed without further issues.This was discovered during a knee arthroscopy and acl procedure on 6/2/2022 additional information received on 6/27/2022: surgeon used ar-4030c-09 fastthread biocomposite interference screw to complete the case.
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: BIO-COMPR INTERF SCRW,FULL THD
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 19257658
• Report Number: 1220246-2024-02863
• Device Sequence Number: 16789828
• Product Code: MAI
• UDI-Device Identifier: 00888867015593
• UDI-Public: 00888867015593
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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 Expiration Date: 12/31/2025
• Device Model Number: BIO-COMPR INTERF SCRW,FULL THD
• Device Catalogue Number: AR-1390TC
• Device Lot Number: 14892740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown