MAUDE Adverse Event Report: ARTHREX, INC. PUNCH, LARGE 2.75MM, 15 DEG UP CURVED; ACCESSORIES, ARTHROSCOPIC

Model Number PUNCH, LARGE 2.75MM, 15 DEG UP CURVED

Device Problems Component Missing (2306); Difficult to Open or Close (2921)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

The precise cause for the related condition could not be determined.Missing tip pin was not returned along with the complaint device.Unable to perform a function test due to the related condition.

Event Description

It was reported, that during knee procedure jaw on the ar-11210, would not open.The case was completes using a different punch.Additional information 2/10/2021 per the sales rep- ar-11210 / batch 82412 ¿ device has a missing tip pin on the distal end of the tip (undetermined).Additional information 2/11/2021 per the sales rep the pin came off after we removed the instrument from the knee.

• Brand Name: PUNCH, LARGE 2.75MM, 15 DEG UP CURVED
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: vik bajnath ; 8009337001
• MDR Report Key: 11398295
• MDR Text Key: 239104987
• Report Number: 1220246-2021-02661
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867002968
• UDI-Public: 00888867002968
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PUNCH, LARGE 2.75MM, 15 DEG UP CURVED
• Device Catalogue Number: AR-11210
• Device Lot Number: 82412
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1