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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
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 facility reported a perforator (id 261221) failed to disengage at proximity of the dura.Additional information received: - the motor did not stop in time and continued after drilling.- did the problem occur during the first trephine hole? yes, the problem occurred during the first hole.- was the surgery time increased as a result of this incident? yes, the surgery time increased by approximately 10 minutes.- did the incident result in any consequences for the patient's health? if so, what treatment was necessary? fortunately, the incident did not result in serious consequences; otherwise, there would have been a significant risk of a parietal contusion and therefore permanent hemiplegia.- what is the patient's current health status? the patient is thankfully doing well.- what is the brand of motor used with the drill? brand: medtronic - is the motor electric or pneumatic? electric - was the drill correctly assembled with the motor? yes, the drill was correctly assembled.- were the recommended tests performed between each hole? only one trephine hole was drilled.- was the approach angle perpendicular as indicated in the operating instructions? yes, the angle was indeed perpendicular.- was the perpendicular approach angle maintained during drilling, or was a rocking motion observed? yes, the perpendicular angle was maintained.- was constant downward pressure applied? yes, constant pressure was applied.

• 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: 24593998
• Report Number: 3014334038-2026-00024
• Device Sequence Number: 21421481
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: 7502205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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
• Patient Sex: Unknown