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

Model Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Date 09/26/2022

Event Type  Injury  

Event Description

A physician reported disengagement failure of a disposable perforator (id (b)(4)).The disengagement failure occurred during surgery and dural damage and minor brain contusion were observed.It occurred at making the first burr hole at the tent.Hemostasis and dura suturing were performed.The surgical time was extended for less than 30 minutes.The manufacturer of the drill used with the perforator was a mr8 (medtronic).According to reporter, it is unknown if the drill was electric or pneumatic, if the perforator clicked in place in the drill.It is also unknown if the recommended spring tests were performed between each burr hole.The patient is in the follow up.

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

N/a.

Manufacturer Narrative

The disposable perforator (id 261221) was returned for evaluation.Device history record (dhr) - here is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - visual inspection performed that revealed that the unit was lightly soiled and had a worn "eo" label.Functional spring test performed, unit passed the spring test and was determined to function as designed.Functional test performed, unit successfully drilled 5 holes and was found to function as intended.Conclusion, complaint could not be verified.Unit was found to meet all acceptance criteria.Therefore the complaint condition per the failure analyst could not be confirmed.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 and potential causes of failure include: user misuse.

• 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: 15583750
• MDR Text Key: 301560175
• Report Number: 3014334038-2022-00230
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 261221
• Device Catalogue Number: 261221
• Device Lot Number: 6435846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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: 71 YR
• Patient Sex: Male