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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem No Code Available (3191)

Event Date 02/28/2014

Event Type  Injury  

Event Description

The affiliate reported "it was reported that the perforator did not stop drilling after going through the bone and entered the brain tearing the dura and causing some bleeding." the patient is fine and no long term deficit.

Manufacturer Narrative

Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

Upon completion of the investigation, the returned perforator was visually inspected as received, disassembled and cleaned, and then visually and dimensionally inspected.No discrepancies were found.The perforator was reassembled and was functionally tested for cutting and drilling.It was found to meet specification requirements.The reported condition could not be duplicated.Review of the device history record has found no discrepancies.At this time, the complaint is considered to be closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• 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: 3672729
• MDR Text Key: 16058288
• Report Number: 1226348-2014-11301
• 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

• Date FDA Received: 03/11/2014
• 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: MF022S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2014
• 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