MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

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 4/2/2024, it was reported by a distributor via sems-06530349 that an ar-2323bcc suture anchor, biocomposite swivelock suture anchor broke when the surgeon went to place the lateral anchor.This was discovered during a procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 4/9/2024: all pieces were retrieved from the patient.There was no case delay reported.The case was completed using another anchor with the speed bridge technique without adverse effects on the patient.This was discovered during a right shoulder arthroscopy procedure on (b)(6) 2024.

• Brand Name: BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
• 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: jared engle ; 8009337001
• MDR Report Key: 19180923
• MDR Text Key: 341791252
• Report Number: 1220246-2024-02375
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026728
• UDI-Public: 00888867026728
• Combination Product (y/n): N
• PMA/PMN Number: K203495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/25/2024

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: BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
• Device Catalogue Number: AR-2323BCC
• Device Lot Number: 15190994
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2024
• 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