MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 6208000000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2013

Event Type  malfunction  

Event Description

It was reported that upon receipt at the user facility the device was leaking an unknown substance resembling blood.As this was an out-of-box failure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The reported leak was confirmed by a manufacturer repair technician.Upon evaluation, it was confirmed that the leaking substance was excess lubricant, which can be caused by a mechanical issue.

• Brand Name: SYSTEM 6 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: kate longman ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3551234
• MDR Text Key: 19732460
• Report Number: 0001811755-2014-00022
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972367
• 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: 07/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6208000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2013
• Date Manufacturer Received: 07/11/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2013
• 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