MAUDE Adverse Event Report: ARTHREX, INC. HANDLE, T, KEYLESS CHUCK CANNULATED; ORTHOPEDIC MANUAL SURG INSTR

Model Number	HANDLE, T, KEYLESS CHUCK CANNULATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the handle during use.As no further investigation was able to be performed no change in harm was identified.
Event or Problem Description
On 03/06/2022 it was reported by a sales representative via sems that ar-8954-02 t-handle lot: 78421725, broke in half.This was discovered during use in a during a calcaneal fracture repair procedure on (b)(6) 2022.The surgeon opened a second 3.5/4.0 and the ar-8954-02 t handle lot:78421642 was locked and rusted.

• Brand Name: HANDLE, T, KEYLESS CHUCK CANNULATED
• Common Device Name: ORTHOPEDIC MANUAL SURG 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: jared engle ; 8009337001
• MDR Report Key: 19478115
• Report Number: 1220246-2024-05093
• Device Sequence Number: 4071569
• Product Code: LXH
• UDI-Device Identifier: 00888867055247
• UDI-Public: 00888867055247
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/06/2024

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 Model Number: HANDLE, T, KEYLESS CHUCK CANNULATED
• Device Catalogue Number: AR-8954-02
• Device Lot Number: 78421725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown