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

Catalog Number 5400034000

Device Problem Component Falling (1105)

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

Event Date 09/30/2014

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility that the device would not hold the blade.The procedure was completed successfully using an alternative blade.No clinically significant delay, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported that during a surgical procedure at the user facility, the device would not hold the blade.The procedure was completed successfully using an alternative blade.No clinically significant delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

Follow-up report submitted to document device evaluation results.

• 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: 4221783
• MDR Text Key: 4995210
• Report Number: 0001811755-2014-03931
• 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,Followup
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• 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: 10/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2005
• 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