MAUDE Adverse Event Report: ARTHREX, INC. PUNCH, LARGE 2.75MM, 15 DEG UP CURVED; MANUAL INSTR, GENERAL SURGICAL

Model Number	PUNCH, LARGE 2.75MM, 15 DEG UP CURVED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation is not confirmed.One unpackaged ar-11210 large punch lot number: 22104 was received for investigation.Visual evaluation of the device noted some discoloration and scratches on the palm.The most likely cause for this can be attributed to wear and tear.It was further noted that the shaft of the device was bent towards the right.The most likely cause for this can be attributed to misuse/mishandling due to the damage to the device.The ar-11210 large punch was further examined under a magnifier and the device was observed to be fully intact, no missing pins, parts, or fragments were observed.Functional testing was performed and it was noted that the device functions as intended and was able to cut through the test sheet.Refer to investigation photos.
Event or Problem Description
On 04/17/2024, it was reported by a facility representative via sems-06541976 that an ar-11210 large punch left a piece of metal in the patient.This occurred during a procedure where the metal was taken out, and the patient was okay.
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
Correction: b3.Additional information: b5, g3, h6.
Event or Problem Description
Additional information was provided on 04/21/2024 where the facility representative stated that this event occurred during a knee arthroscopy on (b)(6) 2024.The surgeon was using the instrument to cut the meniscus and a metal fragment was discovered while using the instrument.An alternate instrument was used to complete the procedure.

• Brand Name: PUNCH, LARGE 2.75MM, 15 DEG UP CURVED
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: jared engle ; 8009337001
• MDR Report Key: 19297522
• Report Number: 1220246-2024-03160
• Device Sequence Number: 6980524
• Product Code: NBH
• UDI-Device Identifier: 00888867002968
• UDI-Public: 00888867002968
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2024

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, LARGE 2.75MM, 15 DEG UP CURVED
• Device Catalogue Number: AR-11210
• Device Lot Number: 14598451
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 04/21/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 09/10/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown