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 Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2023

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)2023, it was reported by a sales representative via email that an ar-2324bcc biocomposite swivelock c was faulty.This was discovered during a procedure.No further information was provided.Additional information received on (b)(6)2023: this was discovered during an rcr procedure on (b)(6) 2023.Upon inserting the anchor, it stripped.The anchor did not break, and the case was completed using another ar-2324bcc biocomposite swivelock c.

Manufacturer Narrative

Additional information: h6.The complaint is not confirmed.The device was not returned for evaluation; no pictures were provided.Per the event description, "during an rcr procedure on (b)(6) 2023.Upon inserting the anchor, it stripped.The anchor did not break, and the case was completed using another ar-2324bcc biocomposite swivelock c." it is concluded that the anchor threads were stripped during the insertion.The most likely cause(s) for the reported failure can be a user error, improper bone preparation, or misaligned insertion; however, due to the device not being returned, we are unable to confirm the reported event.Per dfu-0087 at revision 2.G.Precautions.4.Pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.6.Pushlock and swivelock suture anchors only: ensure that the anchor body is in full contact with the bone before advancing the anchor body into the prepared bone socket.8.Self-punching pushlock and swivelock suture anchors only: ensure that the angle of anchor insertion is perpendicular to the bone.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18013237
• MDR Text Key: 327699416
• Report Number: 1220246-2023-08395
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026827
• UDI-Public: 00888867026827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• 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: 15122643
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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