MAUDE Adverse Event Report: TERRAGENE S.A. STRYKER SCIRY; CHEMICAL INDICATOR

Model Number	STRYKER SCIRY
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	12/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No malfunction evidenced.No clear information was shared about the case, although we tried to reach the client several times.No device-related death or serious injury was reported.However, there's a possibility of device malfunction according the initial description of the customer which could cause the device to fail to perform its essential function and compromise the sterilization process monitoring effectiveness, possibly contributing to death or serious injury.
Event or Problem Description
User reported that the chemical indicators were unusable right out of the package.

• Brand Name: STRYKER SCIRY
• Common Device Name: CHEMICAL INDICATOR
• Manufacturer (Section D): TERRAGENE S.A.; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A.; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 18467505
• Report Number: 3013145340-2024-00014
• Device Sequence Number: 7079604
• Product Code: JOJ
• UDI-Device Identifier: 07798164678212
• UDI-Public: 07798164678212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 01/08/2024

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 Model Number: STRYKER SCIRY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown