MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL MEDIUM STRAIGHT ATTACHMENT; DENTAL OPERATIVE UNIT AND ACCESSORIES

Catalog Number 5100015250

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

The micro drill medium straight attachment was returned to stryker instruments for service.During functional testing by a service technician, it was found that the bur walks out of the attachment during the cut test.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.

Manufacturer Narrative

The event for bur retention was confirmed by the technician through functional evaluation, disassembly and visual inspection.It is possible that the device failed due to the integrated bearing moving.The attachment is not a repairable device and will therefore not be returned to the user facility.

• Brand Name: MICRO DRILL MEDIUM STRAIGHT ATTACHMENT
• Type of Device: DENTAL OPERATIVE UNIT AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4156153
• MDR Text Key: 4784101
• Report Number: 0001811755-2014-03544
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5100015250
• Device Lot Number: 13266
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1