MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Brain Injury (2219)

Event Date 02/23/2021

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 a perforator malfunctioned.The perforator was reportedly checked prior to use as recommended by the instructions for use.While the provider was drilling the cranium suddenly the clutch did not engage and it plunged, causing a very slight perforation of the dura.The perforator was removed from the sterile field.Another perforator was used without difficulty.No further information was available.

Manufacturer Narrative

Additional information received: 1.Manufacturer of the drill used with the perforator drill manufacturer: medtronic.2.Was the drill electric or pneumatic? pneumatic drill.3.Did the perforator click in place in the drill? yes.4.Are the recommended spring tests being performed between each burr hole? yes.5.Intervention/treatment for the injury - no treatment required.6.Healing status of the patient - not necessary as no treatment required.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h10 udi - (b)(4).Product was returned, and the following was performed on the returned unit: the perforator unit was inspected using the unaided eye.Unit was observed to have been autoclaved/exposed to heat (deformed blue sleeve) visible tooling marks on the outer drill.Ifu testing was performed after re-sleeving the unit because the ifu test could not be performed in the ¿as received¿ condition.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.The unit was found to perform as intended and fulfilled the acceptance criteria after it was re-sleeved.It was attempted to drill with the sleeve deformed, but it would not.Therefore, the sleeve was changed to a new sleeve and performed as intended.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.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 11477709
• MDR Text Key: 249474009
• Report Number: 3014334038-2021-00046
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1