MAUDE Adverse Event Report: ARTHREX, INC. PUNCH MENISCL R,2.75MM 15RT CRVD SFT; ACCESSORIES, ARTHROSCOPIC

Model Number	PUNCH MENISCL R,2.75MM 15°RT CRVD SFT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2021
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 shoulder arthroscopy performed on (b)(6) 2021, the meniscal punch broke.There were no fragments reported, and the procedure was completed using a new device of the same part number.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-11392, batch 66831 was received for investigation.Visual inspection identified that the right tip-tube was severely bent.However, no breakage was noted.Functional testing revealed that manipulating the finger would not consistently cause the jaws to actuate, indicating that the handle pin within the handle assembly had broken.The observed condition is consistent with user applied excessive force during use.

• Brand Name: PUNCH MENISCL R,2.75MM 15RT CRVD SFT
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12393649
• Report Number: 1220246-2021-03594
• Device Sequence Number: 4381618
• Product Code: NBH
• UDI-Device Identifier: 00888867003200
• UDI-Public: 00888867003200
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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,Followup
• Report Date (Section B): 10/06/2021

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 MENISCL R,2.75MM 15°RT CRVD SFT
• Device Catalogue Number: AR-11392
• Device Lot Number: 66831
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/06/2021
• Patient Sequence Number: 1