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

Model Number 261221

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2023

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 a disposable perforator (id 261221) was damaged when trying to remove the tip from the burr hole after drilling.According to information provided, the manufacturer of the drill is unknown, it is also unknown if the drill was electric or pneumatic, 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 (id 261221) has been 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 the unaided eye performed.The unit was received disassembled and was soiled with a worn eto label.Spring test could not be performed "as is" due to being received disassembled.Functional test could not be performed due to the unit being received disassembled.Root cause - per the failure analyst ¿unit had a shallow weld this weld likely contributed to the disassembly of the unit during surgery¿.

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: 16502930
• MDR Text Key: 311042982
• Report Number: 3014334038-2023-00023
• 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

• 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: 6416521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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