MAUDE Adverse Event Report: ABBOTT MEDICAL DRG TUNNELING TOOL KIT

Model Number	MN15000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the surgical procedure was completed on (b)(6) 2024, after the procedure it was determined that the tunnelling tool used during surgery was expired.No adverse consequences to the patient have been reported.
Additional Manufacturer Narrative
It was reported that the tunneling tool transferred between accounts and used beyond the expiration date.This wasn't noticed during the procedure.This is a disposable device and there is not impact in the patient.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: DRG TUNNELING TOOL KIT
• Common Device Name: DRG TUNNELING TOOL
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18834162
• Report Number: 1627487-2024-07349
• Device Sequence Number: 17925363
• Product Code: PMP
• UDI-Device Identifier: 05415067027184
• UDI-Public: 05415067027184
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: MN15000
• Device Lot Number: 8310309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 06/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown