MAUDE Adverse Event Report: ARTHREX, INC. PUNCH, MED 3.4MM, 15 DEG UP, STRAIGHT; ACCESSORIES, ARTHROSCOPIC

Model Number	PUNCH, MED 3.4MM, 15 DEG UP, STRAIGHT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a meniscectomy surgery the central axis of the third device broke.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.Update 20-aug-2021: it was confirmed that the surgery took place in iran and one device broke inside the patient.All broken parts were retrieved from the patients body and no further complications occurred.
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.
Additional Manufacturer Narrative
The complaint is confirmed.(1) unpackaged ar-12350 was received for investigation.Visual inspection revealed signs of wear and tear, including scratches and fading laser marks.Functional testing revealed the device is incapable of punching though the testing material.When the punch mechanism encounters resistance, it fails to close completely, even though the finger handle has traveled the full distance towards the thumb handle.Since the device was manufactured in or before july of 2015, the probable cause can be attributed to normal wear and tear.

• Brand Name: PUNCH, MED 3.4MM, 15 DEG UP, STRAIGHT
• Common Device Name: 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: 14469647
• Report Number: 1220246-2022-04958
• Device Sequence Number: 4975295
• Product Code: NBH
• UDI-Device Identifier: 00888867005853
• UDI-Public: 00888867005853
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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, 15 DEG UP, STRAIGHT
• Device Catalogue Number: AR-12350
• Device Lot Number: 10083
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown