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

Catalog Number 261221

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2023

Event Type  malfunction  

Event Description

A facility reported "the drill was not piercing the patient's skull": "the starter drill started the trepanning process, however, it stopped halfway through the procedure.Cutting has stopped, and is necessary to use other means to end the trepanation".No patient injury reported.

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 Description

N/a.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 perforator (id (b)(4)) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.The unit was lightly soiled and had a worn label.Instructions for use (ifu) testing procedure was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.Furthermore, the customer provided a video of the use of this perforator, in an effort to show what was happening.The investigation team reviewed this video in conjunction with the testing of the unit, and it was noticed in the video that the perforator is spinning in reverse (counterclockwise).As with any standard drill, the clockwise direction is to create holes/drill into the surface, whereas the counterclockwise direction is to remove material from the created hole and will not drill into the surface.The perforator moving counterclockwise explains why the drill would not drill into the skull of the patient.The complaint state could be verified through the video visualization.Root cause analysis - per the complaint background, drill was not drilling.The complaint was confirmed in the complaint investigation via the customer¿s video provided in the complaint report.Per the video and analysis performed in the investigation, the root cause is user error as the drill was spinning in the counterclockwise direction.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18129691
• MDR Text Key: 328024107
• Report Number: 3014334038-2023-00181
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513599
• UDI-Public: 10381780513599
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: 7055910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1