MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VENOM100MM MULTIGEN2 ELECTRODE; GENERATOR, LESION, RADIOFREQUENCY

Catalog Number	8400-825-010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the electrode broke off during the case.It should be noted the the procedure was completed successfully and there was no medical intervention, surgical delays, or adverse consequences to the patient at all.
Event or Problem Description
It was reported that the tip of the electrode broke off during the case.It should be noted the the procedure was completed successfully and there was no medical intervention, surgical delays, or adverse consequences to the patient at all.
Additional Manufacturer Narrative
The device was not made accessible for testing; therefore, a root cause could not be determined for the event.

• Brand Name: VENOM100MM MULTIGEN2 ELECTRODE
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 19298594
• Report Number: 3015967359-2024-01028
• Device Sequence Number: 6882792
• Product Code: GXD
• UDI-Device Identifier: 07613327173680
• UDI-Public: 07613327173680
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K170242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• 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 Catalogue Number: 8400-825-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown