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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
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 on 01/06/2023 by a sales representative via sems that an ar-8550pr powerrasp fell apart.Case involvement, device broke during use.This item was found to break halfway through the procedure, where we then opened up another rasp of the same lot number, and inserted that into the shaver handle after we extracted some of the red pieces of plastic that were stuck in the shaver handle, i then lowered the rpms to 5500 and we began to use the rasp again and a second time this item failed where the red plastic she¿s broke inside the shaver handle.We then had to extract a plastic pieces out of the shaver handle and we switch to a regular burr to finish the case.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error.Per dfu-dfu-0215-5- precautions 6.Do not allow the rotating portion of any device to touch any metallic object, such as a cannula or arthroscope, during use.Damage to both devices is likely.Damage to the device can range from a slight distortion or dulling of the blade/bur edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16223475
• Report Number: 1220246-2023-06160
• Device Sequence Number: 6306763
• Product Code: GFF
• UDI-Device Identifier: 00888867044067
• UDI-Public: 00888867044067
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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 Model Number: POWERASP, 5.5MM X 13CM
• Device Catalogue Number: AR-8550PR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown