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

Device Problem Failure to Auto Stop (2938)

Patient Problem Tissue Damage (2104)

Event Date 01/13/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by the ous rep, a codman perforator plunged through the dura.The perforator has been saved for analysis.

Manufacturer Narrative

Udi: unknown part number, udi unavailable.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.

Manufacturer Narrative

Device was returned.Upon completion of the investigation, a followu p report will be filed.

Manufacturer Narrative

Upon completion of the investigation it was noted that the perforator has significant damage to the plastic and metal.Drill was functionally tested 5x.Drill performance was acceptable all 5x.Drill performance was not found defective.No cause could be found for the complaint.The device history records could not be reviewed since the lot number was not reported.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 PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6286675
• MDR Text Key: 66061584
• Report Number: 1226348-2017-10072
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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