MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/24/2021

Event Type  malfunction  

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 Description

On (b)(6) 2021, it was reported by a distributor via email that an ar-1938ps suturetak peek anchor broke.This was discovered during a procedure on (b)(6) 2021.When surgeon impacted the inserter up to the last laser mark, anchor broke.After receiving additional information on 12/22/2021, distributor has confirmed that this occurred during an ankle instability procedure and the broken anchor was not retrieved from inside the patient.Case was completed using a product from another manufacturer.

• Brand Name: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• Type of Device: 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: 13225383
• MDR Text Key: 287121092
• Report Number: 1220246-2022-04259
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867024229
• UDI-Public: 00888867024229
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K180594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• Device Catalogue Number: AR-1938PS
• Device Lot Number: 13667407
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2021
• Date Device Manufactured: 07/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1