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

Catalog Number 6297000000

Device Problem Unintended Power Up (1162)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2018

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.  product return status: 1 device was received.Evaluation status: 1 device evaluation is in progress.  additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.

Event Description

This report summarizes 1 malfunction event in which the device ran without user activation.1 event had no patient involvement; no patient impact.

Event Description

This report summarizes 1 malfunction event in which the device ran without user activation.1 event had no patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.  supplemental rationale corrected data: 1 previously reported event is included in this follow-up record.  product return status 1 device was received.Event confirmation status 1 reported event was confirmed; the cause traced to component failure.Evaluation results 1 device was found to be affected by a damaged electrical component.

• Brand Name: ELECTRIC 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
• MDR Report Key: 8284733
• MDR Text Key: 134598368
• Report Number: 0001811755-2019-00256
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613154495801
• UDI-Public: 07613154495801
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6297000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1