MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERTAS PLUS ELECTRONIC TOOL KIT

Catalog Number	828852
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The certas plus electronic tool kit was not returned for evaluation (is not available for return as per customer) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined, however, a potential root cause is internal short within battery causing rapid increase in temperature.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
A physician reported a burning smell during use of a certas electronic tool kit (id 828852).It was confirmed that the battery was overheating.The device would not turn on even after replacing the battery.The new battery also overheated.The procedure was completed with a replacement product available.No patient injury reported, and the event did not led to surgical delay.

• Brand Name: CERTAS PLUS ELECTRONIC TOOL KIT
• Common Device Name: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23497139
• Report Number: 3014334038-2025-00141
• Device Sequence Number: 12978653
• Product Code: JXG
• UDI-Device Identifier: 10381780532897
• UDI-Public: 10381780532897
• Combination Product (Y/N): N
• PMA/510(K) Number: K181902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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 Catalogue Number: 828852
• Device Lot Number: 12062775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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