MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW CAN-DELTATPR 9X 35MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number BIO-COMP INTERFSCRW CAN-DELTATPR 9X 35MM

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2022

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 most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

Event Description

On 4/19/2022, it was reported by a distributor via email that an ar-5035tc-09 biocomposite interference screw had an issue.This was discovered during a procedure on (b)(6) 2022.Additional information requested.

• Brand Name: BIO-COMP INTERFSCRW CAN-DELTATPR 9X 35MM
• 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: 19071948
• MDR Text Key: 340167925
• Report Number: 1220246-2024-01915
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867035508
• UDI-Public: 00888867035508
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K071176
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BIO-COMP INTERFSCRW CAN-DELTATPR 9X 35MM
• Device Catalogue Number: AR-5035TC-09
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No
• 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