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 Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2014

Event Type  malfunction  

Event Description

It was reported that the system 5 sagittal saw activated as soon as it was connected to the battery during testing or setup prior to a procedure.There was no patient involvement and no adverse consequences associated with the device.

Event Description

It was reported that the system 5 sagittal saw activated as soon as it was connected to the battery during testing or setup prior to a procedure.There was no patient involvement and no adverse consequences associated with the device.

Manufacturer Narrative

The device is being evaluated by a stryker foreign subsidiary; a follow up may be submitted when the quality investigation is complete.

Manufacturer Narrative

The reported unintended activation was duplicated by a manufacturer repair technician through functional evaluation.Upon disassembly, the motor was found to be damaged due to no lubrication or cleaning, which can lead to the reported event.

• 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: 3633514
• MDR Text Key: 4203012
• Report Number: 0001811755-2014-00522
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K972367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4208000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2009
• 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