MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR 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)
Date of Event	03/10/2022
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 it was not possible to adjust the settings of a valve with the certas tool kit.A replacement product was used to adjust the valve.
Additional Manufacturer Narrative
The certas tool kit was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - upon visual inspection, the supplier noted that the unit was not packaged properly.The indicator was frozen and non-functional.Upon disassembly of the indicator, it was found the that pivot pin was severely damaged on both sides.The dial was completely separated from the yoke assembly which rendered the unit inoperable.Based on the analysis conducted, the complaint could be confirmed.Root cause - the complaint was confirmed in the complaint investigation; the returned unit was damaged and non-function due to a severe drop/impact.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.The risk remains acceptable per the risk analysis.
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 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: 13943452
• Report Number: 3013886523-2022-00116
• Device Sequence Number: 19952294
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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: AM1705A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2017
• 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