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
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12434409
• Report Number: 1220246-2021-03606
• Device Sequence Number: 4892612
• Product Code: NBH
• UDI-Device Identifier: 00888867005808
• UDI-Public: 00888867005808
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/07/2021
• Patient Sequence Number: 1