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 Abrasion (1689)

Event Date 01/12/2015

Event Type  Injury  

Event Description

It was reported that during biopsy surgery the perforator continued to drill without stopping before hitting the dura.It was reported that it took away 50% of the dura in the area of the cut.It was further reported that the event caused some bleeding which was stemmed quickly by the engineer.The surgery was completed successfully.A delay of 5 minutes was reported.The patient is reported to be well with no further medical intervention being required as a result of this event.

Event Description

It was reported that during biopsy surgery the perforator continued to drill without stopping before hitting the dura.It was reported that it took away 50% of the dura in the area of the cut.It was further reported that the event caused some bleeding which was stemmed quickly by the engineer.The surgery was completed successfully.A delay of 5 minutes was reported.The patient is reported to be well with no further medical intervention being required as a result of this event.It was subsequently reported that nothing unusual was seen on any ct scans performed after the procedure.

Manufacturer Narrative

The device is not available for return.A follow up report will be filed once the quality investigation is complete.Device discarded by the customer.

Manufacturer Narrative

A review of the manufacturing records for the reported device has not revealed any discrepancies.The quality investigation is complete.Device discarded by customer.

• 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: 4444882
• MDR Text Key: 5387591
• Report Number: 0001811755-2015-00278
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/13/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Catalogue Number: 5100060001
• Device Lot Number: 14293047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 01/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• 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): Other