MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN; POWERED SURG ORTHOPEDIC INSTR

Model Number	DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2023
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.
Event or Problem Description
On 11/09/2023, it was reported by a sales representative via (b)(4) that an ar-1938dss disposable kits drill guide melted.This occurred during a case.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 misuse/mishandling due to damage to the device.

• Brand Name: DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 18286694
• Report Number: 1220246-2023-09274
• Device Sequence Number: 6667701
• Product Code: HWE
• UDI-Device Identifier: 00888867287389
• UDI-Public: 00888867287389
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/10/2025

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: DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN
• Device Catalogue Number: AR-1938DSS
• Device Lot Number: 15047437
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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