MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN 11MM DISPOSBL PERFORATR; DISPOSABLE PERFORATORS

Catalog Number	261222
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	05/29/2025
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 261222) failed to disengage causing dural damage, requiring dural reconstruction to treat the damage.A surgical delay of less than 30 minutes was reported.The perforator was used during a brain tumor removal surgery.The drill used with the perforator was an anspach.According to information provided, it is unknown if the drill was electric or pneumatic, or if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.Additionally, it is unknown if a perpendicular approach was maintained throughout the drilling process, whether any rocking motion occurred, or if constant downward pressure was applied.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The disposable perforator (id 261222) was not returned for evaluation as the product is not available for return as per customer and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined, however, a potential cause of the premature disengagement may be related to poor aseptic technique or lack of care on part of healthcare professional (user misuses device).If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN 11MM DISPOSBL PERFORATR
• 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: 22283716
• Report Number: 3014334038-2025-00081
• Device Sequence Number: 8310027
• Product Code: HBF
• UDI-Device Identifier: 10381780513605
• UDI-Public: 10381780513605
• Combination Product (Y/N): N
• PMA/510(K) Number: K071931
• 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): 08/08/2025

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: 261222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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