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

Catalog Number 26-1221

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2014

Event Type  Injury  

Event Description

Hospital reported via a phone call that during a perforation when the surgeon reached the dura the device did not stop damaging the dura.The patient is ok.The device will be returned for investigation.Explant kit ihas been requested to ship to the customer on (b)(4) 2014.

Manufacturer Narrative

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

Manufacturer Narrative

The perforator was evaluated by the supplier and it was found to be within specifications.This perforator met all visual and functional testing requirements.The root cause of the reported problem "during a perforation when the surgeon reached the dura the device did not stop damaging the dura" was not determined.All evaluation tests and inspections had acceptable results.The perforator met functional test method acceptance requirements; proper engagement was achieved with every drilled hole, and there was no premature disengagement.Review attached supplier evaluation report.The perforator was evaluated by the supplier and it was found to be within specifications.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; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3958485
• MDR Text Key: 4629018
• Report Number: 1226348-2014-11855
• 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
• 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: 07/25/2014
• 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: KF014S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2013
• 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