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

Catalog Number 26-1221

Device Problem Plunge (1462)

Patient Problem Brain Injury (2219)

Event Date 08/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

Failed to stop when it should have and therefore went through the dura.The condition of the patient immediately after the event: "critical".

Manufacturer Narrative

The perforator was not returned (discarded) for evaluation; therefore, the root cause of this complaint could not be verified.We will continue to monitor for this or similar complaints for this product code and lot number.The device history records for this perforator were reviewed.All tests and inspections associated with the assembly and manual functional tests met specification requirements.No further action is required.This complaint in considered to be closed at this time.

Manufacturer Narrative

Upon completion of the investigation it was noted that the customer¿s complaint of "failed to stop" was not verified.This perforator met the test method acceptance requirements; proper engagement and disengagement were achieved with every drill hole.There was no premature disengagement or erratic and poor cutting action.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 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: 5087106
• MDR Text Key: 26150187
• Report Number: 1226348-2015-10530
• 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: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup,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: FH012S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/02/2015; 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2014
• 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