MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE ONLY

Catalog Number	828800PL
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A facility reported a certas valve (id 828800pl) was unable to change setting after implantation procedure.The physician attempted to program the valve to a different setting, but it remained unchangeable.As a result, the surgeon had to remove the valve from the patient.
Additional Manufacturer Narrative
The certas valve (id 828800pl) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 6.The valve was visually inspected; no defects noted but presence of biological debris was noted in the housing.The valve passed the test for programming, occlusion, leak, reflux and pressure.The valve functions.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.A root cause for the issue reported by the customer could be due to improper handling of the device or could be due to biological debris and protein build up interfering with the valve.At the time of investigation, no programming issue was noted.

• Brand Name: CERTAS PLUS INLINE VALVE ONLY
• Common Device Name: CERTAS PLUS
• 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 ; 6099362319
• MDR Report Key: 18740863
• Report Number: 3013886523-2024-00035
• Device Sequence Number: 6509965
• Product Code: JXG
• UDI-Device Identifier: 10381780521013
• UDI-Public: 10381780521013
• 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): 04/26/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 828800PL
• 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: 02/05/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown