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

Catalog Number 6207000000

Device Problem Unintended Power Up (1162)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2016

Event Type  malfunction  

Event Description

It was reported that during device evaluation conducted at the manufacturer facility the device ran at a high speed.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

Device evaluation complete.

Event Description

It was reported that during device evaluation conducted at the manufacturer facility the device ran at a high speed.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: SYSTEM 6 STERNUM SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-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: 5976328
• MDR Text Key: 55566936
• Report Number: 0001811755-2016-02371
• Device Sequence Number: 1
• Product Code: HWE
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6207000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2009
• 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