MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN CERTAS TOOL KIT; CERTAS PLUS PROGRAMMING REPLACEMENT PARTS

Model Number	82-8851
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 the certas tool kit was not able to adjust the valve setting.No patient injury or consequences.
Additional Manufacturer Narrative
The certas tool kit was returned for evaluation: dhr: the unit met all manufacturing quality testing/inspection specifications at the time of distribution.Failure analysis: it was noted that the returned unit is an obsoleted part, and the supplier no longer has the proper equipment to test the unit.However, they did look at the unit and determined that the dial appears to move freely when in motion and that the unit did appear to release the dial with the depression of the button and lock the dial upon release of the button.The complaint product appeared to be in working order.Based on the analysis conducted, the complaint could not be confirmed.Root cause: the complaint unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.Potential root causes include user misuse, or use of obsoleted part.
Event or Problem Description
N/a.

• Brand Name: CODMAN CERTAS TOOL KIT
• Common Device Name: CERTAS PLUS PROGRAMMING REPLACEMENT PARTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14021547
• Report Number: 3014334038-2022-00069
• Device Sequence Number: 2571457
• Product Code: JXG
• UDI-Device Identifier: 10886704074793
• UDI-Public: 10886704074793
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: 82-8851
• Device Catalogue Number: 828851
• Device Lot Number: AM1108A
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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