MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 150MM MULTIGEN2 ELECTRODE; GENERATOR, LESION, RADIOFREQUENCY

Catalog Number	8400-815-015
Medical Device Problem Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Sales representative reported during sterilization that the probe broke.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.Waiting for product to be returned for functional evaluation.
Additional Manufacturer Narrative
It was determined after receiving further clarification from the functional evaluations, this event was not a reportable event.This supplemental is being filed to identify an mdr was not required for this event.
Event or Problem Description
Sales representative reported that the end of the probe came off.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.An update was received that the probe did not break off and this event is not reportable.

• Brand Name: 150MM 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: 20468127
• Report Number: 3015967359-2024-01916
• Device Sequence Number: 7629602
• Product Code: GXD
• UDI-Device Identifier: 07613327173703
• UDI-Public: (01)07613327173703(11)110308
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 12/04/2024

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: 8400-815-015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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