MAUDE Adverse Event Report: ARTHREX, INC. POWERPICK, 45 DEG; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	POWERPICK, 45 DEG
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy surgery the handles of the four devices broke.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device from another manufacturer.It was not necessary to switch the surgical technique or do a second surgery.Update 30-jun-2022 it was confirmed that the plastic handle broke, which prevented the wire from sliding out.All broken parts were retrieved from the patient.The surgery was finished successfully with a new device with the same part number.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint is confirmed.Four ar-8150pp-45 were received for evaluation.Visual inspection noted one device had its lever broken off, and the broken lever had not been returned.Another device had the curved part of the shaft slightly bent.It was also noted that the levers were the incorrect component.Per ar-8150pp-45 bom, the required lever component is c1206-01, but the levers present are 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.It is likely that the operator encountered a stuck lever and, applying excessive force, broke one of the levers.The cause for the broken lever is thus attributed to misuse.

• Brand Name: POWERPICK, 45 DEG
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, 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: vik bajnath ; 8009337001
• MDR Report Key: 15040488
• Report Number: 1220246-2022-05242
• Device Sequence Number: 20145825
• Product Code: GFA
• UDI-Device Identifier: 00888867042919
• UDI-Public: 00888867042919
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: 07/31/2025
• Device Model Number: POWERPICK, 45 DEG
• Device Catalogue Number: AR-8150PP-45
• Device Lot Number: 11561427
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown