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

Model Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

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

Event Date 03/24/2023

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 disengagement failure of a disposable perforator (id (b)(6)) during surgery.It occurred at making the first burr hole at the tent.Since it was used without pressing, it was said that it did not lead to damage to the dura mater.The procedure was completed with a replacement product available.Surgical time was extended less than 30 minutes.The patient recovered.The manufacturer of the drill used with the perforator was bien air/yufu.According to information provided, it is unknown if the drill was electric or pneumatic, and it is unknown if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.In addition, it is unknown if the perpendicular approach maintained through the drilling process or if there was any rocking motion included, and also unknown if there was constant downward pressure.

Manufacturer Narrative

The codman 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 was performed utilizing the unaided eye, unit was lightly soiled and had a partially worn eo label.A spring test was performed, unit passed the spring test and functioned as designed.Functional test performed, unit successfully drilled 5 holes with no issues.Therefore, the complaint condition could not be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.However, the possible root cause is: ''user misuse¿ or drill allows to be set incorrectly¿.

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: 16732423
• MDR Text Key: 313317493
• Report Number: 3014334038-2023-00048
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 261221
• Device Catalogue Number: 261221
• Device Lot Number: 6910170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2023
• 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: 59 YR
• Patient Sex: Female