MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP S-TAK 2.4X 12MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP S-TAK 2.4X 12MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
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) 2022, it was reported by a sales representative via email that an ar-1934bcf-24-2 bio-composite suturetak broke during insertion.Another one was used and case was completed without further issues.This was discovered during an arthroscopic bankart repair on (b)(6) 2022.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1934bcf-24-2 was received for investigation.Visual inspection identified the proximal-most thread of the implant had cracked and bent.A probable cause is attributed to prying/leveraging during insertion.

• Brand Name: BIO-COMP S-TAK 2.4X 12MM
• 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: 14270352
• Report Number: 1220246-2022-04830
• Device Sequence Number: 5310223
• Product Code: MAI
• UDI-Device Identifier: 00888867023918
• UDI-Public: 00888867023918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091844
• 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): 07/01/2022

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: 07/31/2025
• Device Model Number: BIO-COMP S-TAK 2.4X 12MM
• Device Catalogue Number: AR-1934BCF-24-2
• Device Lot Number: 13949882
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown