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	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/5/2024, it was reported by an arthrex subsidiary employee via email that an ar-1390tc full thread cannulated biocomposite interference screw tip broke off.Everything was removed from the patient, and a new screw was used to complete the case.This was discovered during a procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 10/01/2024: this was discovered during a knee arthroscopy and acl procedure.The case was completed using an extra screw.The case was not delayed, and additional anesthesia was not needed.
Additional Manufacturer Narrative
Complaint allegation is confirmed per the photo provided by the customer which shows a broken screw.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• 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: 20238834
• Report Number: 1220246-2024-07688
• Device Sequence Number: 15619908
• Product Code: MAI
• UDI-Device Identifier: 00888867015593
• UDI-Public: 00888867015593
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup,Followup
• Report Date (Section B): 01/21/2025

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: BIO-COMPR INTERF SCRW,FULL THD
• Device Catalogue Number: AR-1390TC
• Device Lot Number: 15195123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: Not provided; 12/26/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/10/2024; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown