MAUDE Adverse Event Report: ARTHREX, INC. PNCH, MD 15 UP TP, 3.4 STR, W/FLUSHPORT; ARTHROSCOPIC ACCESSORIES

Model Number	PNCH, MD 15 UP TP, 3.4 STR, W/FLUSHPORT
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic surgery rust was visible on the jaw.The stuff said the rust was visible on the monitor.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as one unpackaged, ar-12350f, batch number 15122994, was received for investigation and the evaluation revealed that the tip shows slight signs of metal surface oxidation (see evaluation pictures 3 - 6).The most likely cause for the reported failure can be attributed to wear and tear due to the age of the device (manufacturing year 2023).Upon functional testing it was observed that the shear pin is broken (see evaluation pictures 1 + 7).

• Brand Name: PNCH, MD 15 UP TP, 3.4 STR, W/FLUSHPORT
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 22783828
• Report Number: 1220246-2025-03438
• Device Sequence Number: 9906893
• Product Code: NBH
• UDI-Device Identifier: 00888867252516
• UDI-Public: (01)00888867252516(11)230801(10)15122994
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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, MD 15 UP TP, 3.4 STR, W/FLUSHPORT
• Device Catalogue Number: AR-12350F
• Device Lot Number: 15122994
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown