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	Insufficient Information (4580)
Date of Event	02/15/2022
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 arthrex employee via email that an ar-1934bcf-24-2 suturetak came off during use.This was discovered during a procedure on (b)(6) 2022.Additional information received (b)(6) 2022: this was discovered during a labral repair procedure.The suturetak anchor broke off inside the patient and all fragments were retrieved.Case was completed successfully without further issues using an ar-1934bcf-24-2 biocomposite suturetak.
Additional Manufacturer Narrative
Complaint not confirmed.Visual evaluation on the returned anchor did not show any damaged or breakage.Device functioning was not performed due to the returned condition of the device (only the anchor was returned).No problem found.

• 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: 13684822
• Report Number: 1220246-2022-04568
• Device Sequence Number: 14505150
• 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): 04/25/2022

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: 02/16/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 04/25/2022
• 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