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

Catalog Number	828804PL
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a certas valve (id 828804pl) was leaking cerebrospinal fluid (csf) at the top of the reservoir.The issue was noticed as the surgeon was preparing to close the site and stated that as if there was a hole in it.The event led to 30-minute surgical delay.The procedure was completed with a replacement product available.
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
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The certas valve (id 828804pl) was returned for evaluation.Device history record (dhr) - the product code 82-8804pl with lot 7332352, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 4.The valve was visually inspected and cut marks were noted on the connector.The valve was leak tested, leak between the needle chamber and the connector was noted.Root cause analysis - the root cause for the issue reported by the customer is due to improper handling of the device in view of the cut marks on the connector and or is due a sharp or pointed object coming into contact with the valve in view of the cut marks on the connector.As noted in the surgical procedure precautions section in ifu, silicone has a low cut/tear resistance.

• 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: 19950118
• Report Number: 3013886523-2024-00225
• Device Sequence Number: 18383195
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: (01)10381780521174(17)281130(10)7332352
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 828804PL
• Device Lot Number: 7332352
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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
• Patient Age: 53 YR
• Patient Sex: Unknown