MAUDE Adverse Event Report: ARTHREX, INC. PUNCH/TAP 4.75MM BC CORKSCREW; ORTHOPEDIC MANUAL SURG INSTR

Model Number PUNCH/TAP 4.75MM BC CORKSCREW

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/09/2021

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.Complaint confirmed, the tip of the device is bent.The laser mark is also discolored, and the handle is bent.The gouges at the proximal end indicate the device was impacted.A likely cause of the bent tip is user-applied mechanical forces.

Event Description

It was reported during a rotator cuff the punch bent while punching into the bone.It was used to complete the process and the case was completed with no further issues.No patient injury or adverse effect.

• Brand Name: PUNCH/TAP 4.75MM BC CORKSCREW
• Type of Device: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19165688
• MDR Text Key: 340856030
• Report Number: 1220246-2024-02264
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867239173
• UDI-Public: 00888867239173
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2024

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: PUNCH/TAP 4.75MM BC CORKSCREW
• Device Catalogue Number: AR-1927PTB-475
• Device Lot Number: 011901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1