MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS RA SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Model Number	828824PL
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch report #: 5201770000-2023-8076 a facility reported that a physician was unable to program the certas valve (id (b)(6)).The event happened during set up for surgical procedure, the patient was not in the operating room yet.The physician grabbed the second programmer using the same valve, but was still unable to program.Therefore, the physician grabbed a new valve and was able to get it to program properly.The first valve was believed to be defective.
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, h6, h10 the certas valve (id 828824pl) was returned for evaluation.Device history record (dhr) - the product code 82-8824pl with lot 6748242, 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, no defect noted.The valve passed the test for programming.The complaint was unconfirmed.Root cause - no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.However, the possible root cause for the issue reported by the customer could be due to improper handling of the device.At the time of investigation no function issues were noted.

• Brand Name: CRTS RA SG VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA 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 ; 6099362319
• MDR Report Key: 17182972
• Report Number: 3013886523-2023-00188
• Device Sequence Number: 12426890
• Product Code: JXG
• UDI-Device Identifier: 10381780529491
• UDI-Public: (01)10381780529491(17)271031(10)6748242
• 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): 07/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 828824PL
• Device Catalogue Number: 828824PL
• Device Lot Number: 6748242
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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