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

Catalog Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Date 05/10/2023

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 physician reported a disposable perforator id (b)(6) did not stop when the operator drilled again for a deep brain stimulation (dbs).A thicker-than-usual bone pad remained when drilling and the dura was damaged during the procedure requiring a dura suture.The event led to more than 30 minutes surgical delay the patient recovered.A primado2(nakanishi) drill was used with the perforator.According to information provided, it is unknown if the perforator clicked in place in the drill, it is also unknown if the recommended spring tests were performed between each burr hole.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6 & h10.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: visual inspection utilizing unaided eye performed.The unit was heavily soiled with organic material and was subjected to eo gas.Spring test attempted.Unit had a frozen i/o drill from significant organic material present.Unit was cleaned and used to drill 5 test holes, and this freed the frozen i/o.Once freed, unit passed the spring test and functioned as designed.Functional test performed.Once freed, the unit successfully drilled an additional 5 holes with no issues and functioned as designed.The complaint condition could not be confirmed.Unit passed all functional tests.Root cause- the root cause remains undetermined.The product was received for analysis and the investigation could not confirm the complaint.The possible root cause per the failure analyst ¿drill allows to be set incorrectly¿ or ¿user misuse¿.

Event Description

N/a.

• 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: 17100876
• MDR Text Key: 316931337
• Report Number: 3014334038-2023-00086
• 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: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: 6899305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2022
• 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
• Patient Age: 65 YR
• Patient Sex: Male