MAUDE Adverse Event Report: UNKNOWN PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

Device Problem Failure to Auto Stop (2938)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Sales rep.Called on (b)(6) 2014, and reported that the customer had two disposable perforator incidents.Sales rep.Contacted the customer two times, but no other information was provided.On (b)(6) 2014, the sales rep.Called and informed the both disposable perforators failed to disengage and caused damaged to the dura, but they did not go into the brain.Event dates are unknown.Patient's information and condition are unknown.Product codes and lot numbers are unknown.No other information available at this time.Sales rep.Will make another attempt to contact the customer to obtain more information.Also see complaint # (b)(4).

Manufacturer Narrative

It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Device not returned.

• Brand Name: UNKNOWN PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4126199
• MDR Text Key: 4946071
• Report Number: 1226348-2014-12009
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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