MAUDE Adverse Event Report: ARTHREX, INC. PNCH, WB XL, 2.75 W/FLUSHPORT; MANUAL INSTR, GENERAL SURGICAL

Model Number	PNCH, WB XL, 2.75 W/FLUSHPORT
Medical Device Problem Codes	Failure to Cut (2587); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an arthroscopic surgery the rivet from the mechanism fell off and therefore the device does not cut.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
Additional information: b5, d9, g3, h3, h6.The reported event was confirmed as the visual evaluation of the received ar-11040xlf with batch 15472327 noted that the tip pin is missing (see evaluation pictures 2 + 3).A functional test was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.Further, the shaft is slightly bent (see evaluation picture 1).
Event or Problem Description
Update dw 11-dec-2025: further information was provided that the reported issue was identified prior to use on the patient.The surgery was later finished successfully but no further information was provided how the procedure was then performed.

• Brand Name: PNCH, WB XL, 2.75 W/FLUSHPORT
• 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: 23744166
• Report Number: 1220246-2025-05484
• Device Sequence Number: 10350024
• Product Code: MDM
• UDI-Device Identifier: 00888867272828
• UDI-Public: (01)00888867272828(11)250725(10)15472327
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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, WB XL, 2.75 W/FLUSHPORT
• Device Catalogue Number: AR-11040XLF
• Device Lot Number: 15472327
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown