MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VENOM® 100MM MULTIGEN 2 ELECTRODE; GENERATOR, LESION, RADIOFREQUENCY

Model Number	8400-825-010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the electrode broke off during a rf procedure, posing a risk that this material could be left behind in the patient, during use in a surgical procedure.At this point no additional event details were provided, and attempts are being made to gather additional information.
Additional Manufacturer Narrative
Follow-up report submitted to document additional event details and completed investigation.H3 other text : discarded by customer.
Event or Problem Description
It was reported that the tip of the electrode broke off during a rf procedure, posing a risk that this material could be left behind in the patient, during use in a surgical procedure.The procedure was successful, there was no medical intervention, no delays, and no adverse consequences were reported.

• Brand Name: VENOM® 100MM MULTIGEN 2 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15823806
• Report Number: 3015967359-2022-02318
• Device Sequence Number: 15008463
• Product Code: GXD
• UDI-Device Identifier: 07613327173680
• UDI-Public: 07613327173680
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/13/2023

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: 8400-825-010
• Device Catalogue Number: 8400-825-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 02/13/2023
• 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