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

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Brain Injury (2219)

Event Date 03/11/2021

Event Type  Injury  

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

A facility reported that on (b)(6) 2021, the codman disposable perforator¿s security system did not function during a craniotomy.The customer indicated that normally during perforation, the 2 cylinders worked synchronized and when the first cylinder went after the cranial part, first cylinder went out which stopped the perforation and blocked the instrument.Accidental opening of the dura during surgery occurred.The surgeon had to repair the "opened" dura and finish the procedure.No neurological deficits were reported.

Manufacturer Narrative

Additional information received: the event led to surgical delay, unknown for how long.

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.Failure analysis - the perforator unit was inspected using the unaided eye.Unit was slightly soiled and had a worn label, but no other anomalies were observed.Ifu testing was performed with no observed anomalies after the inner/outer drill were free from being fused.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.Product was received for analysis and the investigation could not confirm the complaint.The risk remains acceptable per the risk analysis.Although the complaint was not confirmed, root cause was investigated using the risk documentation.Per 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.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 11791874
• MDR Text Key: 256755618
• Report Number: 3014334038-2021-00094
• Device Sequence Number: 1
• Product Code: HBF
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: J8967K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1