MAUDE Adverse Event Report: ARTHREX, INC. POWERASP,4.0MM X 13CM; MANUAL INSTR, GENERAL SURGICAL

Model Number	POWERASP,4.0MM X 13CM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an ankle fusion surgery the powerasp melted and came apart in the hand piece.The same thing happened with second one.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with different part number.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Visual inspection of the device revealed the attachment hub was completely broken off.The broken attachment hub has melted residue along the rim.In addition, there is corrosion visible on the shaft of the device.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the attachment during use and insufficient fluid flow during use.
Event or Problem Description
Update swit 18-aug-2023: according to the surgeon, he was doing nothing out of the ordinary but that towards the back of the joint the rasp stopped working and when he took it out, the end had been melted.He didn¿t know what happened as he used the same way as normal.

• Brand Name: POWERASP,4.0MM X 13CM
• Common Device Name: MANUAL INSTR, GENERAL 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: emily shafer ; 8009337001
• MDR Report Key: 17461978
• Report Number: 1220246-2023-07425
• Device Sequence Number: 2698425
• Product Code: GFF
• UDI-Device Identifier: 00888867043619
• UDI-Public: 00888867043619
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 10/21/2024

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: 04/30/2026
• Device Model Number: POWERASP,4.0MM X 13CM
• Device Catalogue Number: AR-8400PR
• Device Lot Number: 13341819
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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