MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN CRANIOTOMY KIT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number 26-1230

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The perforator did not disengage.Risk of dura matter perforation and brain injury.

Manufacturer Narrative

Upon completion of investigation, a follow up report will be filed.Complaint sample not returned.

Manufacturer Narrative

The perforator was not returned; therefore, the reported "the perforator did not disengage" could not be verified.Evaluation will be performed when/if the perforator is eventually received.The device history records for this perforator were reviewed.All assembly process tests and inspection associated with the assembly process, met specification requirements.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Device not returned.

Event Description

Additional information stated: the sales rep and the hospital were asked.They cannot confirm there was a dura or brain injury.They just mention a risk.It is the same for (b)(4).If i get further information from the hospital , i will keep you informed.

• Brand Name: CODMAN CRANIOTOMY KIT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): CODMAN & SHURTLEFF; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3923275
• MDR Text Key: 4517273
• Report Number: 1226348-2014-11806
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK933894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1230
• Device Lot Number: KF021S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1