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

Catalog Number	261221
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2025
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: "when using a perforator during surgery, there were problems such as the dura being rolled in and bone fragments protruding." no patient injury reported.Type of procedure: "aneurysm mcab".
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h11.The disposable perforators was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history records (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint is the risk file potential causes include not following ifu prior to using the perforator.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.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The disposable perforator (id 261221) was returned for evaluation.Device history review: no anomalies were identified that occurred during the manufacture or packaging of the device.Failure analysis: the device was visually inspected.Device was lightly soiled.No other defect or damage found.Label on sleeve was worn.On the initial attempt, the spring test was difficult to perform.After multiple spring test attempts, the unit successfully passed the spring test and functioned as intended.The unit was likely frozen due to the soiling observed.The drill was successfully validated with the tachometer.A reading of 936 rpm was measured.The specification is 850-1250 rpm.Unit successfully drilled 5 holes, and the perforator functioned as designed.The complaint was not confirmed.Root cause analysis: per the risk file potential causes include not following ifu prior to using 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: 23257896
• Report Number: 3014334038-2025-00138
• Device Sequence Number: 4940767
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

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: 7448842
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 02/06/2026
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 11/26/2025; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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