MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTER-FERENCE SCRW; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP INTER-FERENCE SCRW
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
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.One unpackaged ar-5028c-09 was received for investigation.Visual inspection identified that the threads along the returned biocomposite screw had stripped both at the distal and proximal ends.The hex was clogged with remnants of tissue, and additional pieces of tissue were identified within the threads.It was identified that the method used to prepare the bone, as well as the bone quality encountered during the procedure, were not provided.As such, a probable cause can be attributed to improper bone preparation.
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the device did not offer any hold during insertion.The thread did not grip and did clearly strip off.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (ar-5035tc-09).It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: BIO-COMP INTER-FERENCE SCRW
• 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: 19257716
• Report Number: 1220246-2024-02867
• Device Sequence Number: 14105244
• Product Code: MAI
• UDI-Device Identifier: 00888867035331
• UDI-Public: 00888867035331
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• 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: 04/30/2025
• Device Model Number: BIO-COMP INTER-FERENCE SCRW
• Device Catalogue Number: AR-5028C-09
• Device Lot Number: 13363234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown