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 12/24/2014

Event Type  malfunction  

Event Description

It was reported that during preparation for a surgical procedure conducted at the user facility the device was unintentionally running when the battery was connected.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was confirmed by a manufacturer repair technician through functional evaluation.Upon disassembly, it was found several components needed to be replaced, including the carriage return, which can lead to the reported event.As requested by the user facility, the device was returned unrepaired.

Event Description

It was reported that during preparation for a surgical procedure conducted at the user facility the device was unintentionally running when the battery was connected.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this 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: 4439383
• MDR Text Key: 5390628
• Report Number: 0001811755-2015-00242
• 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: Health Professional,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4208000000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2009
• 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