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

Catalog Number	261221
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	12/26/2025
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) failed to stop and damaged the dura mater and the nonfunctional part of the brain.Hemostasis was performed as an immediate measure to manage the patient¿s condition.There was less than 30 minutes of surgical delay.According to information provided, the manufacturer of the drill used with the perforator is unknown.It is unknown if the drill was electric or pneumatic.It is also unknown if the perforator clicked in place in the drill, and if the recommended spring tests being performed between each burr hole.Three burr holes were completed before the perforator malfunctioned.It is unknown if there have been recent changes with the drill and with the driver.It is also unknown how the procedure was completed.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The disposable perforator (id 261221 was returned for evaluation.Failure analysis: the returned device was visually inspected.Device was lightly soiled.No other defect or damage found.Device pass all functional tests including spring test per ifu and unit successfully drilled 5 holes, and the perforator functioned as designed.The complaint was not confirmed.Root cause analysis: the complaint was not confirmed in the complaint investigation and failure analysis.A potential cause of the be related to the angle positioning, pressure and/or incorrect fit between the hudson driver and the perforator body application during use.

• 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: 24133371
• Report Number: 3014334038-2026-00003
• Device Sequence Number: 10387223
• Product Code: HBF
• UDI-Device Identifier: 10381780513599
• UDI-Public: 10381780513599
• Combination Product (Y/N): N
• PMA/510(K) Number: K791101
• 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,Followup
• Report Date (Section B): 03/23/2026

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 Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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