MAUDE Adverse Event Report: RAYNHAM CODMAN CERTAS TOOL KIT; CERTAS PLUS PROGRAMMING REPLACEMENT PARTS

Model Number	82-8851
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
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 physician reported it was not possible to adjust the valve.After checking the indicator tool, the adjustment tool does not adjust to the desired valve value, therefore, the valve was revised/replaced.The patient did not experience any symptoms.
Additional Manufacturer Narrative
Unique device identifier (udi) : (b)(4).The valve was not returned for evaluation therefore, an evaluation of the device could not be performed.Serial number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
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 - minor damage to the pivot pin was noted during the review.The unit passed in all directions except for in the vertical mode for programming.The supplier noted that the unit would be rejected at final inspection in this condition.The supplier also notes that while the results are somewhat inconclusive, that the damage to the pin within the unit could have contributed to the failure of the unit to program, and cause that lack of sensitivity.Based on the analysis conducted, the complaint could be confirmed.Root cause - the complaint was confirmed in the complaint investigation.Per the supplier, the potential root cause is the pivot pin sustaining minor damage, most likely from being dropped.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.

• Brand Name: CODMAN CERTAS TOOL KIT
• Common Device Name: CERTAS PLUS PROGRAMMING REPLACEMENT PARTS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 10792451
• Report Number: 3013886523-2020-00183
• Device Sequence Number: 17093766
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 82-8851
• Device Catalogue Number: 828851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/24/2020; 04/19/2022
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/10/2020; 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2019
• 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