MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORATOR BIT LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number 5100060001

Device Problem Failure to Auto Stop (2938)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2014

Event Type  malfunction  

Event Description

It was reported that during a craniotomy procedure the perforator bit did not stop when it went through the skull.It was further reported that the device was being used on the left temporal location of the skull at the time of this event.The procedure was completed successfully with no adverse consequences or medical intervention reported as a result of this event.

Event Description

It was reported that during a craniotomy procedure, the perforator bit did not stop when it went through the skull.It was further reported that the device was being used on the left temporal location of the skull at the time of this event.The procedure was completed successfully with no adverse consequences or medical intervention reported as a result of this event.

Manufacturer Narrative

H6: the device has been returned.A follow up report will be filed once the quality investigation is complete.

Manufacturer Narrative

The device was returned for evaluation.The quality investigation is complete.

• Brand Name: PERFORATOR BIT LARGE 14/11MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: dervillia murphy ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 3929402
• MDR Text Key: 4587947
• Report Number: 0001811755-2014-02479
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2014
• Device Catalogue Number: 5100060001
• Device Lot Number: 13309017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2014
• 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