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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The related condition is typically caused by applying excessive force while attempting to cut tissue and/or an excessive amount of tissue at one time.Fragments were accounted for and found during investigation/evaluation process.Function test could not be performed due to the related condition.Unrelated, device also has a bent shaft.
Event or Problem Description
It was reported that the device is defective due to a broken push rod.There was no harm or adverse event for patient, operator or third party reported.No further information received.
Additional Manufacturer Narrative
The related condition is typically caused by applying excessive force while attempting to cut tissue and/or an excessive amount of tissue at one time.Fragments were accounted for and found during investigation/evaluation process.Function test could not be performed due to the related condition.Unrelated, device also has a bent shaft.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• 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: 19165222
• Report Number: 1220246-2024-02255
• Device Sequence Number: 7948981
• Product Code: NBH
• UDI-Device Identifier: 00888867252516
• UDI-Public: 00888867252516
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/28/2024

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: PNCH, MD 15 UP TP, 3.4 STR, W/FLUSHPORT
• Device Catalogue Number: AR-12350F
• Device Lot Number: 10332452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2019
• 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