MAUDE Adverse Event Report: CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problem Material Integrity Problem (2978)

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

Event Date 07/28/2021

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

A physician reported the perforator disassembled at the time of trepanning during a craniotomy procedure.It occurred during making the second burr hole at the tent.The procedure was completed with a replacement product.It is unknown the drill manufacturer, or if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.

Manufacturer Narrative

The perforator 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 disassembled and had a worn "eo" label.The ultrasonic weld on the blue sleeve was visibly protruding and stuck out enough to catch sliding objects on the surface.The weld should be flush with the rest of the sleeve to hold the unit together.The "ifu" testing procedure was performed: the unit was tested as received with the parts put together but not re-sleeved (not re-welded); it passed the spring test as is designed.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to not perform as intended.While the unit did successfully drill 5 holes, it was unstable and shaking/wobbly while doing so.The complaint was confirmed in the complaint investigation.The failure analysis performed confirmed that the unit had a proud weld which likely caused the unit to fail during surgery.A corrective action was implemented to evaluate this failure.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• MDR Report Key: 12332172
• MDR Text Key: 266931385
• Report Number: 3014334038-2021-00169
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• 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: J88X04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2020
• 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