MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS PEDIATRIC CRANIOTOME, BM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME

Catalog Number B-TURQ-X

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Event Description

This is report 1 of 2 for the same event.It was reported that during an unspecified neuro surgery, it was observed that the attachment device "was not working" when in use with the motor device.It was unknown if there were any delays to the surgical procedure or if a spare device was available for use.There were no injuries reported.It was unknown to the reporter if medical intervention or prolonged hospitalization were required.The date of the event was unknown.Several attempts have been made to obtain additional information concerning the reported event; however, no additional information has been provided.A supplemental medwatch report will be submitted if further information is received.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device.A visual and functional assessment was performed and found the tip was bent and was unable to insert a cutter.Therefore, the reported condition was duplicated and confirmed.The assignable root cause was determined to be improper handling.

• Brand Name: PEDIATRIC CRANIOTOME, BM
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 3598036
• MDR Text Key: 4192614
• Report Number: 1045834-2014-11268
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-TURQ-X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2014
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MOTOR DEVICE