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

Catalog Number 4100400000

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2015

Event Type  malfunction  

Event Description

It was reported that during equipment testing conducted by a manufacturer service technician that the device was overheating.No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device was tested by a manufacturer service technician and the device was found to be operating within specification.

Event Description

It was reported that during equipment testing conducted by a manufacturer service technician that the device was overheating.No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: SAGITTAL SAW ATTACHMENT
• 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: 5158750
• MDR Text Key: 28559223
• Report Number: 0001811755-2015-03829
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4100400000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2006
• 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