MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO SAGITTAL SAW; UNIT, OPERATIVE DENTAL

Catalog Number 5400034000

Device Problem Overheating of Device (1437)

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

Event Date 09/25/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure at the user facility the device was overheating.The procedure was completed using an alternative unit.No clinically significant delay, no medical intervention and no adverse consequences were reported as a result of this event.

• Brand Name: MICRO SAGITTAL SAW
• Type of Device: UNIT, OPERATIVE DENTAL
• 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: 4176305
• MDR Text Key: 5156712
• Report Number: 0001811755-2014-03618
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5400034000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2014
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2008
• 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