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

Catalog Number 26-1221

Device Problem Split (2537)

Patient Problem Injury (2348)

Event Date 05/23/2014

Event Type  Injury  

Event Description

The sales rep reported: situation : perforator was attached to a medtronic midas rex drill.Codman perforator did not disengage and then split into two pieces.Perforator penetrated the brain by 4mm.Surgery was delayed appx 30 minutes.Patient is currently stable.

Manufacturer Narrative

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

Manufacturer Narrative

Complaint is currently being investigated under (b)(4) by supplier.The investigation takes 30 days with an anticipated completion date of 7/16/14.Once the investigation report is completed the complaint will be re-opened and updated accordingly.Device is under investigation.

Manufacturer Narrative

Upon completion of the investigation it was noted that the supplier evaluation was received on 7/25/14, there evaluation is as follows:the root cause for the reported problem was not determined.The functional test was not performed (refer to functional test below); therefore, the customers¿ complaint "codman perforator did not disengage", could not be confirmed.There have been no previous customer complaints on perforators from lot dg0225.Functional test: a manual operation and disengagement test (based on the procedure described in the ifu), and a functional test, were not performed.It was judged that the extent and locations of the nicked edges and surfaces observed on the drill body could affect the proper function of the perforator.Dimensional inspections were also not performed due to the extensive damage observed on the drill body.A device history records review as performed and revealed that all tests and inspections associated with the assembly process, met specification requirement.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

• Brand Name: CODMAN DISOPOSABLE 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: 3879556
• MDR Text Key: 15181479
• Report Number: 1226348-2014-11711
• 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,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 Expiration Date: 03/01/2019
• Device Catalogue Number: 26-1221
• Device Lot Number: DG0226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 06/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/22/2014; 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2014
• 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