MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATOR

Catalog Number	261221
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/02/2026
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 a disposable perforator (id 261221) was difficult to make a burr hole.The device got hot and eventually caused a burn on the patient.The procedure was completed with a replacement product available.The details related to the patient's burn are unknown.According to information provided, it is unknown if the perforator failed to engage or had premature disengagement.It is also unknown if the perforator was dull or if the patient's bone thickness/quality was the issue.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h11.The disposable perforator (id (b)(6)) was returned for evaluation.Device history review: no anomalies were identified during the manufacture or packaging of the device.Failure analysis: abnormal levels of heat were not observed.Slowing drill speed or irrigating the perforator can reduce heat buildup.The complaint cannot be confirmed.Root cause analysis: returned product testing identified no nonconformities and no abnormal heat generation.The cranial perforator is designed to interface with bone only and is not intended to contact patient skin when used in accordance with the instructions for use.While the issue was not reproduced potential causes of the excess heat is due to friction.Irrigation or reducing drill speed can decrease the amount of heat built up in the drill.Under intended use conditions, there is no identified mechanism for patient skin exposure to heat.

• Brand Name: CODMAN DISPOS PERFORATOR
• Common Device Name: DISPOSABLE PERFORATOR
• 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: 24624225
• Report Number: 3014334038-2026-00026
• Device Sequence Number: 9015126
• Product Code: HBF
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K791101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: 7564173
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown