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

Catalog Number XXX-CODMAN PERFORATOR

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Contusion (1787); Hematoma (1884)

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 facility reported the perforator did not stop when drilling a burr hole resulting in brain contusion and hematoma.This was the only burr hole needed, so they continued with the case to completion.The event led to less than 30 minutes surgical delay.The perforator click in place with the drill (stryker) and the spring test was performed for the burr hole.

Manufacturer Narrative

Updated fields: d10, g4, g7,h2, h3, h6, h10 the perforator was not returned for evaluation (discarded by customer) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10880898
• MDR Text Key: 217658611
• Report Number: 3014334038-2020-00099
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CODMAN PERFORATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: STRYKER DRILL.