MAUDE Adverse Event Report: TERRAGENE S.A. STRYKER SRBI30F; BIOLOGICAL INDICATOR

Model Number	STRYKER SRBI30
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device-related deaths or serious injuries were informed.Device malfunction cause the device to fail to perform its essential function and compromise the device's monitoring effectiveness, since it would not be able to process biological indicators.If this were to recur, the lack of biological indicators processing could affect the load release, which could contribute to a serious injury due to lack of sterile material if it were to recur.
Event or Problem Description
The distributor reported the biological indicator is showing positive results after the sterilization proceses, not allowing the loads to be released.

• Brand Name: STRYKER SRBI30F
• Common Device Name: BIOLOGICAL INDICATOR
• Manufacturer (Section D): TERRAGENE S.A.; ruta nacional n[?]9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A.; ruta nacional n° 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nacional n° 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 18477203
• Report Number: 3013145340-2024-00015
• Device Sequence Number: 17741995
• Product Code: FRC
• UDI-Device Identifier: 07798164678793
• UDI-Public: 07798164678793
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2024

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
• Device Expiration Date: 09/30/2023
• Device Model Number: STRYKER SRBI30
• Device Lot Number: A10531
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown