MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP-SITE P-LCK 2.9X15.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number BIO-COMP-SITE P-LCK 2.9X15.5MM

Device Problem Break (1069)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

On 3/21/2024, it was reported by a distributor via sems (b)(4) that (3) ar-1923bc suture anchor, biocomposite push lock 2.9 x 15.5 mm anchors kept breaking when impacted to secure implant inside the patient.All broken pieces were retrieved from the patient.The case was completed with a new box with a different lot number with no issues.This was discovered during a shoulder instability repair procedure on (b)(6) 2024.Additional information was received on 4/2/2024: the case was delayed for 25 minutes and no additional anesthesia was administered.There were no adverse effects on the patient.

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: BIO-COMP-SITE P-LCK 2.9X15.5MM
• 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: 19116368
• MDR Text Key: 340456341
• Report Number: 1220246-2024-02049
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867023017
• UDI-Public: 00888867023017
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173240
• 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: 04/16/2024

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-SITE P-LCK 2.9X15.5MM
• Device Catalogue Number: AR-1923BC
• Device Lot Number: 15145600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2023
• 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