MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Catalog Number	828804PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a certas valve (id 828804pl) was not working.Therefore, a revision surgery was performed, and the valve was explanted and replaced with a new device.There is no delay in surgery due to late receipt of product and product problem.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The certas valve (id 828804pl) was returned for evaluation.Device history record (dhr) ¿ product code 82-8804pl with lot 5949429, showed report when released to stock.Failure analysis - the position of the cam when valve was received was at setting 7.The valve was visually inspected; a needle hole in the needle chamber was noted.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The valve was leak tested; only leaked from the needle hole in the needle chamber.Root cause analysis - no root cause could be determined for the issue reported by the customer as the technician could not confirm any functional issues with the valve at the time of investigation.A possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the device.At the time of investigation, no functional issues were noted with the valve.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Common Device Name: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19538710
• Report Number: 3013886523-2024-00168
• Device Sequence Number: 18245791
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: (01)10381780521174(17)261031(10)5949429
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 828804PL
• Device Lot Number: 5949429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown