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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/01/2025
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 that while using a codman perforator (id 261221) to create the third burr hole during a convexity meningioma resection, the device¿s auto-release function did not operate properly.According to the physician, there was no dural defect and no indication of brain contusion.However, significant bleeding occurred from the superior sagittal sinus (sss), which the physician was able to control.The incident resulted in a surgical delay of more than 30 minutes.The patient is for follow-up.According to the information provided, it is unknown if the drill was electric or pneumatic.It is also unknown if the perforator clicked into place in the drill, and if the recommended spring tests were 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: d9, g3, g6, h2, h3, h6, h11.The codman perforator (id: 261221) was returned for evaluation.Failure analysis - the device was evaluated, and the device was heavily soiled but passed all functional tests.The complaint cannot be confirmed.Root cause analysis - a 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.

• 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: 22520710
• Report Number: 3014334038-2025-00102
• Device Sequence Number: 18280550
• 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): 11/26/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: J55X07
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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 Age: 72 YR
• Patient Sex: Male