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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. POWERPICK, 45 DEG; BURR, SURGICAL, GENERAL & PLASTIC SURGERY
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ARTHREX, INC. POWERPICK, 45 DEG; BURR, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number POWERPICK, 45 DEG
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/24/2021
Type of Reportable Event Malfunction
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.
 
Event or Problem Description
It was reported that during a meniscal cx procedure, when the tip of the ar-8150px-45, was inside the joint of the patient and activated, the tip of the device broke.The fragment was removed and the case was completed by using a new ar-8150px-45 without further issue.
 
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Brand Name
POWERPICK, 45 DEG
Common Device Name
BURR, SURGICAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11484719
Report Number1220246-2021-02742
Device Sequence Number19957507
Product Code GFF
UDI-Device Identifier00888867042926
UDI-Public00888867042926
Combination Product (Y/N)N
Initial Reporter CountryMX
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/31/2024
Device Model NumberPOWERPICK, 45 DEG
Device Catalogue NumberAR-8150PX-45
Device Lot Number10300904
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/26/2021
Initial Report FDA Received Date03/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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