MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK C, CLD 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number BIO-COMP SWVLK C, CLD 4.75X19.1MM

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2023

Event Type  malfunction  

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 complaint is confirmed based on the customer provided photo, which displays the anchor that was removed.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

Event Description

On 2/7/2023, it was reported by an arthrex employee via email that an ar-2324bcc biocomposite swivelock anchor does not seat and does not allow placing of the sutures for repair.This was discovered during a procedure on 2/4/2023.Additional information received on 2/10/2023: this was discovered during a shoulder arthroscopy procedure and was completed using another ar-2324bcc biocomposite swivelock.Nothing broke inside the patient.

• Brand Name: BIO-COMP SWVLK C, CLD 4.75X19.1MM
• 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: 19133341
• MDR Text Key: 341389565
• Report Number: 1220246-2024-02117
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026827
• UDI-Public: 00888867026827
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K203495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2024

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 SWVLK C, CLD 4.75X19.1MM
• Device Catalogue Number: AR-2324BCC
• Device Lot Number: 14999340
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1