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

Catalog Number 261221

Device Problem Mechanical Problem (1384)

Patient Problem Brain Injury (2219)

Event Date 04/03/2023

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 nurse reported a codman perforator (b)(6) was fixed/stuck in the cranium during a craniotomy on (b)(6) 2023.They were unable to removed the burr completely and had to do a full craniotomy around it, causing a bruised brain post-op, but otherwise doing fine.A 30-minute surgical delay was reported.The patient was doing fine.The manufacturer of the drill used with the perforator was a pneumatic medtronic drill-midas rex, and the perforator clicked in place in the drill.

Manufacturer Narrative

The disposable perforator (id 261221) 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: a visual inspection utilizing the unaided eye was performed, the unit was received disassembled and was heavily soiled with organic matter.A spring test was attempted, since the unit was received disassembled the device could not be tested "as is".Upon re-assembly of the unit it was noticed that the outer drill was deformed and the inner drill could no longer slide easily into the out drill.The opening of the outer drill was measured with a pin gauge and it was determined that it did not meet manufacturing specifications.The unit was forcefully reassembled and re-sleeved to determine how the unit would drill, once re-sleeved the unit still did not pass the spring test as the deformed outer drill impeded functionality.Functional test performed, unit successfully drilled 5 holes but the perforator was vibrating and was very loud.Complaint could not be verified to be due to manufacturing error.This is highly unlikely to have happened during the manufacturing process as the unit would not have been able to be initially assembled and would have been flagged by the operators.Additionally, the are 2 other inspection points further down the manufacturing process where this defect would have been caught as well.It is likely that the damage to the outer drill occurred during surgery.Although the drill did not pass manufacturing specifications upon return to the investigation facility the complaint condition could not be confirmed due to the damage to the drill occurring during surgery and not a result of its manufacturing.Root cause- the root cause remains undetermined.A dhr review and trending were performed as part of the investigation.Product was received for analysis and the investigation could not confirm the complaint condition.Possible root cause per the failure analyst ¿excessive drill rpm and/or force does not allow proper cut.Drill becomes ¿screwed¿ into skull¿.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16860631
• MDR Text Key: 314462597
• Report Number: 3014334038-2023-00061
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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: 6756571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2022
• 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
• Treatment: PNEUMATIC MEDTRONIC DRILL- MIDAS REX.