MAUDE Adverse Event Report: ARTHREX, INC. PUNCH, MED 3.4MM, 30 DEG RIGHT CURVED; ACCESSORIES, ARTHROSCOPIC

Model Number PUNCH, MED 3.4MM, 30 DEG RIGHT CURVED

Device Problems Break (1069); Component Missing (2306); Material Twisted/Bent (2981)

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

Event Date 08/11/2021

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a meniscectomy surgery two of the three devices ar-12320 (lot 09997) were blunt and the central axis of the third device broke.The provided picture shows that one device is bent and the jaw is missing.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same devices.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: PUNCH, MED 3.4MM, 30 DEG RIGHT 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: 12434409
• MDR Text Key: 271643745
• Report Number: 1220246-2021-03606
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867005808
• UDI-Public: 00888867005808
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/07/2021

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, MED 3.4MM, 30 DEG RIGHT CURVED
• Device Catalogue Number: AR-12320
• Device Lot Number: 09997
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/07/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1