MAUDE Adverse Event Report: ARTHREX, INC. CORKSCREW FT, BC, SUTURETAPE, 4.75M; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number CORKSCREW FT, BC, SUTURETAPE, 4.75M

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2022

Event Type  malfunction  

Event Description

On 11/4/2022, it was reported by a sales representative via (b)(4) that (3) ar-1927bct-475 biocomposite corkscrew ft anchors failed.One failed on the first thread, the second failed when the driver snapped, and the third cracked about halfway in.Surgeon elected to use bone tunnels in lieu of suture anchors to complete the case.Additional information received on 11/14/2022: this was discovered during a quad tendon repair on (b)(6) 2022.Ar-1927bct-475 biocomposite corkscrew ft anchor, from lot number 10494037, broke when screwing it in on the first torque.Another ar-1927bct-475 biocomposite corkscrew ft inserter broke while surgeon was attempting to implant the screw, the torque was too much on the inserter.The anchor itself did not break but it was removed from the patient.The inserter did not break inside the patient.A third ar-1927bct-475 biocomposite corkscrew ft anchor broke and all fragments were retrieved.

Manufacturer Narrative

This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation and/or prying/leveraging during insertion.

• Brand Name: CORKSCREW FT, BC, SUTURETAPE, 4.75M
• 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: jared engle ; 8009337001
• MDR Report Key: 19205507
• MDR Text Key: 341323237
• Report Number: 1220246-2024-02575
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867237858
• UDI-Public: 00888867237858
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Model Number: CORKSCREW FT, BC, SUTURETAPE, 4.75M
• Device Catalogue Number: AR-1927BCT-475
• Device Lot Number: 14945402
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1