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

Model Number	BIOCOMPOSITE INTER- FERENCE SCREW
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/27/2023, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1400c biocomposite interference screw has a damaged thread.There was no patient involvement.
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.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection identified that the threads at the distal tip of the biocomposite interference screw were stripped and broken.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not 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: BIOCOMPOSITE INTER- FERENCE SCREW
• 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: emily shafer ; 8009337001
• MDR Report Key: 18383050
• Report Number: 1220246-2023-09527
• Device Sequence Number: 7805806
• Product Code: MAI
• UDI-Device Identifier: 00888867016163
• UDI-Public: 00888867016163
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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 Expiration Date: 01/31/2026
• Device Model Number: BIOCOMPOSITE INTER- FERENCE SCREW
• Device Catalogue Number: AR-1400C
• Device Lot Number: 14930027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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