MAUDE Adverse Event Report: ARTHREX, INC. POWERASP, 5.5MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	POWERASP, 5.5MM X 13CM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2021
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 big toe base joint rizarthrosis while removing the bone the device produced metal debris.It was further reported that fragments remained inside the joint.The surgery was finished successfully with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8550pr powerasp was received for investigation.Visual inspection identified that the active cam and retaining ring had broken off the proximal end of the device.Damage was noted to either end of the cam spring, and the retaining ring had noticeably deteriorated.The overheating detailed in the event description is most likely the result of insufficient irrigation during use.Surface damage consistent with sites of metal debris production were noted at the distal tip of the powerasp.This is most likely the result of prying/leveraging forces applied during use.

• Brand Name: POWERASP, 5.5MM X 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11540235
• Report Number: 1220246-2021-02755
• Device Sequence Number: 17170878
• Product Code: GFF
• UDI-Device Identifier: 00888867044067
• UDI-Public: 00888867044067
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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 Date: 07/31/2025
• Device Model Number: POWERASP, 5.5MM X 13CM
• Device Catalogue Number: AR-8550PR
• Device Lot Number: 11535288
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 05/03/2021
• Patient Sequence Number: 1