MAUDE Adverse Event Report: ARTHREX, INC. POWERASP, 3.5MM X 13CM; ARTHROSCOPIC ACCESSORIES

Model Number	POWERASP, 3.5MM X 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2024
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.
Event or Problem Description
On 2/1/2024, it was reported by an arthrex subsidiary employee via (b)(4) that while using a powerrasp, ar-8350pr, in an ankle arthroscopy case on (b)(6) 2024, the inner tube of the rasp was broken inside and detached.Since the damaged part was inside the tube and the joint could not be confirmed, the wound was closed after confirming that no metal fragments remained in the surgical field using fluoroscopy and fluoroscopy.The surgery was completed without any problems or delays.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpacked ar-8350pr powerasp, 3.5 mm x 13 cm batch/serial number (b)(6), was received for evaluation.Visual inspection noted that the rasp shaft was broken on the proximal end.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most probable cause is by applying excessive force while grasping and manipulating tissue or when applying excessive leveraging forces.User error is the most likely cause of the reported event.The evidence observed shows that the event is consistent with prying/leveraging against bone.Per dfu-0215-eo at revision 1.Section 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.

• Brand Name: POWERASP, 3.5MM X 13CM
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: jared engle ; 8009337001
• MDR Report Key: 18739404
• Report Number: 1220246-2024-01038
• Device Sequence Number: 6396054
• Product Code: GFF
• UDI-Device Identifier: 00888867043312
• UDI-Public: 00888867043312
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/28/2024

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, 3.5MM X 13CM
• Device Catalogue Number: AR-8350PR
• Device Lot Number: 13348954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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