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

Catalog Number 5100060001

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2016

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Customer discarded the devices.

Event Description

It was reported that during a cranial procedure, while drilling holes, it was noted that metal flaked from the cutting part of 2 perforator bits.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery was completed successfully.

Manufacturer Narrative

The quality investigation is complete.

Event Description

It was reported that during a cranial procedure, while drilling holes, it was noted that metal flaked from the cutting part of 2 perforator bits.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery was completed successfully.

• 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: 5615387
• MDR Text Key: 43896953
• Report Number: 0001811755-2016-00421
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5100060001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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