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

Catalog Number 26-1221

Device Problem Dull, Blunt (2407)

Patient Problem No Information (3190)

Event Date 01/19/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The perforator was dull.The surgeon tried to perforate 4 burr holes with the perforator, but finally could only one burr hole and it took much time.It was reported that the thickness and hardness of the patient¿s bone was average.Another perforator was used to complete the case.No surgical delay or harm to the patient was reported.

Manufacturer Narrative

Upon completion of the investigation it was noted that the customer¿s complaint of "perforator was dull" not verified.This perforator met the test acceptance requirements; proper engagement and disengagement were achieved with every drill hole and there was no erratic or poor cutting action.The device history records for the perforator was reviewed and all test and inspections associated with the assembly process met specification requirements.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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4450460
• MDR Text Key: 21216150
• Report Number: 1226348-2015-10048
• 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: Foreign,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: 01/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: LG017S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• 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