MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYS 6 STERNUM; 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 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the (b)(6), exemption number (b)(4).The reported event was not confirmed for 1 device; the device was found to be within specifications for the reported event.One device is available for evaluation but has not yet been evaluated.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 2 malfunction events in which the device ran in safe mode or the safety of the device did not work, presenting a condition in which the device could be inadvertently activated.There was no patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the (b)(6), exemption number (b)(4).One device was received for evaluation.The event was confirmed; an internal component was found to be missing.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 2 malfunction events in which the device ran in safe mode or the safety of the device did not work, presenting a condition in which the device could be inadvertently activated.There was no patient involvement; no patient impact.

• Brand Name: SYS 6 STERNUM
• 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: 5830750
• MDR Text Key: 51359973
• Report Number: 0001811755-2016-01421
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6207000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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