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

Catalog Number 26-1221

Device Problem Plunge (1462)

Patient Problem Laceration(s) (1946)

Event Date 10/29/2014

Event Type  Injury  

Event Description

Customer called and reported that while in use the device failed to stop cutting through the bone and lacerating the dura.The patient is ok and the surgeon was able to complete the surgery as it did not go past the dura.The device was being used in an aneurysm case.The device will be returned for evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

Upon completion of the investigation it was found that the customer's perforator met functional test acceptance requirements, proper engagement and disengagement was achieved with every drilled hole.In addition, the device history records (perforator assembly) show all tests and inspections, including a drilling test, met specification requirements prior to distribution.The problem reported by the customer could not be duplicated in the laboratory setting.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 considered closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4227207
• MDR Text Key: 4999368
• Report Number: 1226348-2014-12081
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791101
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: HG012S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 11/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2014
• 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