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

Model Number	POWERASP, 5.5MM X 13CM
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported by an arthrex employee via e-mail that an ar-8550pr powerasp was used with revolutions at 4000 rpm, it starts to heat up and breaks.This was discovered during an ankle osteosynthesis on (b)(6) 2021.The case was completed by using a new ar-8550pr.Additional information provided 12/22/21: the base of the blade broke the ¿torque¿ that gives it movement.The ar-8550pr stopped working inside the patient, but when the surgeon removed the device to check it, they noticed that it was burned and the blade detaches from the torque easily.There were no burns to the patient or staff.As soon as they noticed the slightest change in temperature and the smell of burning, they stopped using it.No patient harm.
Additional Manufacturer Narrative
Complaint device was not returned for evaluation.Based on the picture provided by the customer, it is confirmed the hub connector has broken off.The cause of this event remain undetermined; however most likely cause is the application of prying/leveraging forces to the device during use.
Additional Manufacturer Narrative
Complaint device was not returned for evaluation.Based on the picture provided by the customer, it is confirmed the hub connector has broken off.The most likely cause(s) of this type of event include using the device without the use of irrigation to provide cooling; the plastic cam mechanism responsible for the actuation of the device might have heated up and deformed due to the heat.Therefore, the probable root cause is attributed to misuse.

• 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: 13154743
• Report Number: 1220246-2022-04244
• Device Sequence Number: 14777287
• Product Code: GFF
• UDI-Device Identifier: 00888867044067
• UDI-Public: 00888867044067
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 06/07/2023

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: 11/30/2024
• Device Model Number: POWERASP, 5.5MM X 13CM
• Device Catalogue Number: AR-8550PR
• Device Lot Number: 10501675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 12/14/2021; 12/14/2021
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/07/2022; 06/07/2023
• Date Device Manufactured: 12/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown