MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4208000000

Device Problem Unintended Power Up (1162)

Patient Problem No Patient Involvement (2645)

Event Date 04/12/2014

Event Type  malfunction  

Event Description

It was reported that during equipment testing conducted by a manufacturer field service technician at the user facility the device continued to run without user activation after the trigger was released.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.

Event Description

It was reported that during equipment testing conducted by a manufacturer field service technician at the user facility, the device continued to run without user activation after the trigger was released.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.

Manufacturer Narrative

The reported run on was not able to be duplicated by a manufacturer repair technician through functional evaluation.Upon disassembly for visual examination, no components were identified which would have likely caused or contributed to the reported failure.The device was serviced for preventive maintenance and returned to the user facility.

Manufacturer Narrative

Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

• Brand Name: SYSTEM 5 SAGITTAL SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 3799553
• MDR Text Key: 4370734
• Report Number: 0001811755-2014-01672
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 04/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4208000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2003
• 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