MAUDE Adverse Event Report: ARTHREX, INC. BC KNOTLESS SUTURETAK, OPEN REPAIR; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BC KNOTLESS SUTURETAK, OPEN REPAIR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 8/15/2023, it was reported by a sales representative via email that an ar-1938bcs biocomposite knotless suturetak repair and shutting sutures were swedged together.The anchor did not shuttle and broke off.The anchor was left inside the patient, and the fragments were not retrieved.This was discovered during a lateral epicondyle repair procedure on (b)(6) 2023.Additional information requested.
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
Additional information: g3, h3, h6.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 most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion, improper bone prep and/or prying/leveraging the device during use.

• Brand Name: BC KNOTLESS SUTURETAK, OPEN REPAIR
• 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: 17711508
• Report Number: 1220246-2023-07824
• Device Sequence Number: 20520323
• Product Code: MAI
• UDI-Device Identifier: 00888867287365
• UDI-Public: 00888867287365
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 08/31/2023
• Device Model Number: BC KNOTLESS SUTURETAK, OPEN REPAIR
• Device Catalogue Number: AR-1938BCS
• Device Lot Number: 14172677
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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