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.(b)(4) 2014 information requested from customer: there are two products with different lot numbers reported.Did both devices fail to disengage? customer responded: (b)(6) 2014 yes they did.

Manufacturer Narrative

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

Manufacturer Narrative

No gtin number available for this product code (26-1230).Both (2) perforators involved in this complaint were returned for evaluation.The supplier evaluation was received on 8/14/14 and revealed:the root cause of "the perforator did not disengage" was not verified.A manual operation and disengagement test was performed on each (2) perforator.Thumb pressure on the perforator points produced smooth, positive spring actions, and engagement occured as each hudson was rotated.In the disengagement position, each hudson ends' rotation were smooth.The customer's perforators (2) met functional test acceptance requirements proper engagement and disengagement was achieved with every drilled hole.The device history records were reviewed, all tests and inspections 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.

• 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: 3882840
• MDR Text Key: 20269881
• Report Number: 1226348-2014-11719
• 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: 06/19/2014
• 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: KF016S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2013
• 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