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

Catalog Number XXX-CODMAN PERFORATOR

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/08/2021

Event Type  malfunction  

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

It was reported that the perforator plunge.No additional information has been provided.

Manufacturer Narrative

Additional information received: event date: (b)(6) 2021.Drill plunged when performing a burr hole, clutch did not engage, bleeding from underlying vessels.No significant injury.The event led to 30 minutes surgical delay.

Event Description

N/a.

Manufacturer Narrative

The perforator was returned for evaluation: 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.Unit was heavily soiled with visible tool marks and a damaged sleeve.A sizeable hole was observed on the top of the sleeve and the label was destroyed.Ifu testing was performed after re-sleeving.The hole found in the sleeve was not allowing the pin to set correctly, and unit had to be re-sleeved.Testing included: applying adequate pressure on the perforator point, ensuring engagement occurs as the hudson end is rotated.When engagement occurs, placing thumb pressure on the perforator point to ensure a smooth, positive spring action.Ensuring the hudson end rotates smoothly within the perforator body when the unit is in the disengaged position.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.Testing includes: rpm verification of primary drill driver using a laser tachometer via: non-contact method for drills without a safety clutch.Contact method for drills with a safety clutch.Semi-automated process operation.Manual process operation.Passing criteria includes: must disengage as the inner drill tip breaks through and pushes down a round slug.Outer drill should not drill through the bottom of the test board (leaves a shelf between the inner drill diameter and the outer drill diameter).Must complete drilling successfully for a total of five holes.The unit was found to perform as intended and fulfilled the acceptance criteria.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Although the complaint was not confirmed, root cause was investigated using the risk documentation.Potential causes of failure include: perforator components cannot withstand multiple sterilizations/uses, impact introduction of drill to skull able to cause scoring on the pin/triangle/slot interface, inadequate spring (k-factor and/or length), drill used for multiple holes; chatter/deformation of pin/slot interface, drill allows to be set incorrectly, incorrect specification of surface finish for inner drill outer drill and pin, or user misuse.

Event Description

N/a.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 11967179
• MDR Text Key: 255160177
• Report Number: 3014334038-2021-00114
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

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: XXX-CODMAN PERFORATOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 06/11/2021; 08/27/2021
• Supplement Dates FDA Received: 06/29/2021; 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1