MAUDE Adverse Event Report: ARTHREX, INC. 5.5MM BC CORKSCREW FT W/ SUTURETAPE; BIO SOFT TISSUE FIXATN FASTNR

Model Number 5.5MM BC CORKSCREW FT W/ SUTURETAPE

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 12/19/2023

Event Type  malfunction  

Event Description

On 12/20/2023, it was reported by a sales representative via phone that (qty.2) of an ar-1927bct suture anchor, biocomposite corkscrew sutures would not seat in the implant; the loop that holds the suture was hanging out of the anchor and was not secure.The case was completed by removing the anchor and sutures and inserting a new ar-1927bct suture anchor from a different lot.A few minutes of delay were reported in the procedure.This was discovered during a rotary cuff repair procedure on (b)(6) 2023.

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.

• Brand Name: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• Type of Device: 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: 18502384
• MDR Text Key: 333202812
• Report Number: 1220246-2024-00313
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867251267
• UDI-Public: 00888867251267
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• Device Catalogue Number: AR-1927BCT
• Device Lot Number: 15106132
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1