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
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/30/2020
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.
Event or Problem 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.
Additional 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
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11258618
• Report Number: 1220246-2021-02514
• Device Sequence Number: 16776606
• Product Code: NBH
• UDI-Device Identifier: 00888867003187
• UDI-Public: 00888867003187
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 06/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other