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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
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 the grater broke during a surgery.There was no harm for patient, operator or third party.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 confirmed.One unpackaged ar-8400pr, serial number (b)(6), was received for investigation.Three damaged devices were received for evaluation.However, is not possible to identify which device belongs to which case.Pictures of the investigation and evaluation will include all the pieces that were received.A functional test was not performed due to the damage to the device.Visual evaluation found that the outer hub was detached; it was also noted that the plastic was melted.The device was damaged.User error is the most likely cause(s) of reported failure, as mechanical damage to the device, such as hitting the device with another device or object, prying/leveraging, or excessive bending forces applied during use.According to dfu-0215 at revision 1.F.Precautions.7.Excessive "side-loading" on the device during use does not improve cutting performance and in extreme cases will cause irreversible damage to the device.8.Excessive ¿loading¿ on the powerasp device will disengage the cam mechanism and stall the cutting effectiveness.9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).10.Running the device without the flow of irrigation (dry) will cause the device to excessively heat and may cause a thermal burn.

• 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: 18253498
• Report Number: 1220246-2023-09092
• Device Sequence Number: 6644650
• Product Code: GFF
• UDI-Device Identifier: 00888867043619
• UDI-Public: 00888867043619
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/21/2024

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: 11/09/2023
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 12/03/2023
• Supplement Report FDA Received Date: 08/22/2024
• 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