MAUDE Adverse Event Report: ARTHREX, INC. POWERASP,4.0MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	POWERASP,4.0MM X 13CM
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
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
It was reported that during a shoulder arthroscopy the shaver attachment is scorched / burnt through.No harm for patient, operator or third party was reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint device was not returned for evaluation.Based on the picture provided by the customer, it is confirmed the retaining ring is damaged.The cause is undetermined.
Additional Manufacturer Narrative
Complaint device was not returned for evaluation.Based on the picture provided by the customer, it is confirmed the retaining ring is damaged.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,4.0MM 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: 12466757
• Report Number: 1220246-2021-03620
• Device Sequence Number: 3907805
• Product Code: GFF
• UDI-Device Identifier: 00888867043619
• UDI-Public: 00888867043619
• 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,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: 09/30/2025
• Device Model Number: POWERASP,4.0MM X 13CM
• Device Catalogue Number: AR-8400PR
• Device Lot Number: 11982104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 08/23/2021; 08/23/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 02/01/2022; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown