MAUDE Adverse Event Report: ARTHREX, INC. 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY; SCREW, FIXATION, BONE

Model Number	3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2022
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
It was reported on 09/16/2022 by a sales representative via email that an ar-8934bcst suture tape assembly anchor broke while being malleted in.This was discovered during a case and broke inside the joint space.
Additional Manufacturer Narrative
The device was not received for evaluation and no photo was provided; complaint not confirmed.The most likely probable cause of the event is attributed to excessive force when malleting down the anchor.

• Brand Name: 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Common Device Name: SCREW, FIXATION, BONE
• 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: 15534088
• Report Number: 1220246-2022-05555
• Device Sequence Number: 17502492
• Product Code: HWC
• UDI-Device Identifier: 00888867375116
• UDI-Public: 00888867375116
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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: 03/31/2025
• Device Model Number: 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Device Catalogue Number: AR-8934BCST
• Device Lot Number: 13155984
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 08/22/2023
• Date Device Manufactured: 04/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown