MAUDE Adverse Event Report: ARTHREX, INC. PUNCH MENISCL RT TIP 2.75MM STR SFT; ACCESSORIES, ARTHROSCOPIC

Model Number PUNCH MENISCL RT TIP 2.75MM STR SFT

Device Problems Mechanical Problem (1384); Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2020

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.

Event Description

It was reported that during a knee surgery the biting device stopped working directly in the joint cavity.The device was removed from the joint, and the examination revealed that the working part of the punch does not move.It was noticed that there is no small pin that fixes the working part of the punch to the stationary one.The surgeon looked for the pin inside the knee joint but was not able to find the missing pin.It is likely that the part remained inside the patient.The surgery was then finished successfully with a different device and the surgeon did not switch to a different technique.

Manufacturer Narrative

The precise cause for a missing tip pin on the distal end of the tip could not be determined.Missing tip pin was not returned along with the complaint device.Function test could not be performed due to the related condition.Device did not meet the function criteria.

• Brand Name: PUNCH MENISCL RT TIP 2.75MM STR SFT
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11258618
• MDR Text Key: 229627261
• Report Number: 1220246-2021-02514
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867003187
• UDI-Public: 00888867003187
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PUNCH MENISCL RT TIP 2.75MM STR SFT
• Device Catalogue Number: AR-11390
• Device Lot Number: 57469
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other