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

Catalog Number	261221
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Brain Injury (2219)
Date of Event	08/12/2025
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 the auto-release function of the disposable perforator (id 261221) did not function properly while creating the burr hole, resulting in damage to the dura mater.The perforator became stuck in the burr hole and could not be removed, requiring the surrounding bone to be shaved using a diamond burr.It took approximately one hour to control the bleeding.The surgery was completed.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.It is unknown if a perpendicular approach was maintained through the drilling process or was there any rocking motion included.It is also unknown if there was constant downward pressure.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The codman perforator (id 261221) was returned for evaluation.Device history record (dhr) - no anomalies were identified that occurred during the manufacture or packaging of the device.Failure analysis - the device was damaged by a customer with the burr.Per the customer this was after the issue occurred.The label was worn away.The device passed all functional tests.The complaint cannot be confirmed.Root cause analysis - the potential cause of the premature disengagement may be related to the angle positioning, pressure and/or incorrect fit between the hudson driver and the perforator body application during use.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Additional information: "the perforator penetrates brain parenchyma to a depth of 1cm.(bone thickness was approximately 2 cm).The surgeon shaved the bone around it using diamond bur to create a space before pulling the device out.The above event created the damage in the stainless and plastic parts of the perforator.".

• Brand Name: CODMAN DISPOS PERFORATOR
• Common Device Name: DISPOSABLE PERFORATORS
• 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: 22912052
• Report Number: 3014334038-2025-00117
• Device Sequence Number: 21148875
• 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,Followup
• Report Date (Section B): 02/06/2026

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
• Device Lot Number: 7511636
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 01/19/2026
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/26/2025; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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: Other
• Patient Sex: Unknown