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

Catalog Number 828851

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2021

Event Type  malfunction  

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 Description

A facility reported the certas plus tool kit gave inconsistent values.No patient injury, no surgical delay reported.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.Complaint sample 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 - the unit passed the performance test in both the horizontal and vertical orientations.However, it is noted that the certas unit was packaged within its casing incorrectly, and once disassembled it was found that there was damage to the indicator pins.Damage to the indicator pins is usually indicative of the unit being dropped.The supplier noted that the product being put in its packaging incorrectly could also have attributed to the damage to the indicator pins due to being exposed to excessive force.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.Additional information received - the dysfunction was observed during the measurement and changing of the setting.The procedure was completed with a replacement product.

• Brand Name: CODMAN CERTAS TOOL KIT
• Type of Device: 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: 12316667
• MDR Text Key: 266384121
• Report Number: 3014334038-2021-00166
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 828851
• Device Lot Number: AM1410A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1