MAUDE Adverse Event Report: ARTHREX, INC. POWERPICK, 30 DEG; BURR, SURGICAL

Model Number	POWERPICK, 30 DEG
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 07/01/2022 by a facility representative via (b)(4) that an ar-8150pp-30 powerpick lever was stuck and needle was jammed.This was discovered during a case with no patient harm.
Additional Manufacturer Narrative
The complaint is confirmed.One ar-8150pp-30 was received for evaluation.Visual inspection noted that the lever was the incorrect component.Per ar-8150pp-30 bom, the required lever component is c1206-01, but the lever present is c-3901-01.The incorrect levers are a known issue affecting this batch.The issue was addressed in ncr-15261 and an event risk assessment was performed and recorded as plm66913.The incorrect levers prevent their normal operation, sometimes getting stuck.

• Brand Name: POWERPICK, 30 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: 19311072
• Report Number: 1220246-2024-03243
• Device Sequence Number: 11515519
• Product Code: GFA
• UDI-Device Identifier: 00888867042902
• UDI-Public: 00888867042902
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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: 07/31/2026
• Device Model Number: POWERPICK, 30 DEG
• Device Catalogue Number: AR-8150PP-30
• Device Lot Number: 14041117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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