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

Catalog Number	828814PL
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a certas valve (id 828814pl) was implanted 3.5 years ago with setting 5.Using the electronic tool kit (etk), medical staff tried to reprogram shunt to setting 7, however, the valve stayed at 5.After many attempts including with multiple etk kits and magnets, the setting remained at 5.The large magnet could not move the setting off of 5.The patient did not experienced any signs and symptoms of valve malfunction and physician only wanted to program setting 7 as the patient had a subdural due to a fall (the patient fell out of bed a few weeks ago possibly damaging the valve).The valve was replaced on (b)(6), 2023.
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: 828814pl) was returned for evaluation.Failure analysis: the position of the cam when valve was received was at setting 5.The valve was visually inspected; no defect was noted.The valve was hydrated.The valve passed the test for programming.The valve was disassembled and was visually inspected under microscope at appropriate magnification; biological debris was found on the motor and the spring.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 biological debris and protein build up interfering with the valve, at the time of investigation biological debris was found on the motor and the spring.
Event or Problem Description
N/a.

• Brand Name: CRTS SM IL 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: 17480505
• Report Number: 3013886523-2023-00246
• Device Sequence Number: 12987240
• Product Code: JXG
• UDI-Device Identifier: 10381780529378
• UDI-Public: 10381780529378
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: 828814PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/30/2023
• 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