MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL VLV ONLY; CERTAS PLUS SMALL & RA

Catalog Number	828810PL
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a certas valve (id 828810pl) failed during programming.The valve was unable to change settings.Due to failure the valve was removed and replaced.
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, h10 the certas valve (id 828810pl) was returned for evaluation.Device history record (dhr) - the product code 82-8810pl with lot 6318150, conformed to the specifications when released to stock.Failure analysis- the position of the cam when valve was received was at setting 1.The valve was visually inspected; needle hole was noted in the needle chamber.The valve was leak tested, the leak tested passed; only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux and pressure.The valve was dried.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the seat of the ruby ball, motor and spring.Root cause- at the time of investigation no programming issue was noted.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve.The root cause for the pressure test failed, is due to biological debris and protein build up interfering with the valve, at the time of investigation debris biological were noted.
Event or Problem Description
N/a.

• Brand Name: CRTS SM IL VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA
• 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: 17038595
• Report Number: 3013886523-2023-00170
• Device Sequence Number: 7011789
• Product Code: JXG
• UDI-Device Identifier: 10381780529316
• UDI-Public: (01)10381780529316(17)270430(10)6318150
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• 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): 07/28/2023

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: 828810PL
• Device Lot Number: 6318150
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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