MAUDE Adverse Event Report: ARTHREX, INC. PNCH, LG, 2.75 W/FLUSHPORT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	PNCH, LG, 2.75 W/FLUSHPORT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed as the visual evaluation revealed that the tip pin missing and therefore the jaw has come loose.
Event or Problem Description
It was reported that during a cruciate ligament arthroscopy an issue with the reported device occurred.Nothing broke off during the surgery and the procedure was finished with the same device anyway.There was no harm for patient, operator or third party reported.It was not necessary to switch the surgical technique or do a second surgery.23-feb-2022 update dw: further information were provided that a foreign body inside a patient was identified during the check up on an x-ray picture.
Additional Manufacturer Narrative
The reported event was confirmed as the visual evaluation revealed that the tip pin missing and therefore the jaw has come loose.A probable cause could be the result of wear and tear from repeated use or the application of excessive force while interacting with tissue.

• Brand Name: PNCH, LG, 2.75 W/FLUSHPORT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 13757387
• Report Number: 1220246-2022-04590
• Device Sequence Number: 12441119
• Product Code: MDM
• UDI-Device Identifier: 00888867270855
• UDI-Public: 00888867270855
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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: PNCH, LG, 2.75 W/FLUSHPORT
• Device Catalogue Number: AR-11200F
• Device Lot Number: 82677
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown