MAUDE Adverse Event Report: ARTHREX, INC. POWERPICK, 45 DEG; BURR,SURGICAL

Model Number	POWERPICK, 45 DEG
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic surgery the device did no longer work sufficient.After it was triggered three times it went back into the housing hardly.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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.Complaint confirmed.One unpackaged ar-8150px-45 powerpick (no batch indicator present) was received for investigation.Functional testing identified that after the cutting tip was deployed, it was not able to be fully retracted.Visual inspection identified no external damage that would contribute to the observed condition.Due to the fact that the inner tube was not able to be withdrawn from the outer tube, it is undetermined whether damage exists along the inner diameter of the outer tube/along the inner tube.Based off the information provided, the most likely cause for the reported failure can be attributed to prying/leveraging the device against bone and/or hard tissue.

• Brand Name: POWERPICK, 45 DEG
• Common Device Name: BURR,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: 19531443
• Report Number: 1220246-2024-05708
• Device Sequence Number: 15373795
• Product Code: GFF
• UDI-Device Identifier: 00888867042926
• UDI-Public: 00888867042926
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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 Expiration Date: 03/31/2025
• Device Model Number: POWERPICK, 45 DEG
• Device Catalogue Number: AR-8150PX-45
• Device Lot Number: 10871543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown