MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN CRANIOTOMY KIT; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1230

Device Problems Disconnection (1171); Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Event Description

The perforator has disengaged too early and stayed blocked in the patient skull; or it got disconnected from the handpiece; the quality of the surgery is at risk.

Manufacturer Narrative

Upon completion of the investigation it was noted that the customer¿s complaint of "disengaged too early and stayed blocked in the patient skull " was not verified.This perforator met the test method acceptance requirements; proper engagement and disengagement were achieved with every drill hole and there was no erratic and poor cutting action.The device history records for the perforator was reviewed and all test and inspections associated with the assembly process met specification requirements.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: CODMAN CRANIOTOMY KIT
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5470215
• MDR Text Key: 39347654
• Report Number: 1226348-2016-10155
• 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: company representative,foreig
• 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: 03/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1230
• Device Lot Number: KH023S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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
• Patient Outcome(s): Required Intervention