MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 STERNUM SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 7207000000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 09/30/2019

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: 5 events were reported for this quarter.Product return status: 4 devices were received.1 device investigation type has not yet been determined.Event confirmation status: 4 reported events were not confirmed.Evaluation results: 4 devices had no problem found.Additional information: 5 devices were not labeled for single-use.5 devices were not reprocessed or reused.

Event Description

This report summarizes 5 malfunction events in which the device was reportedly leaking.5 events had no patient involvement; no patient impact.

Event Description

This report summarizes 5 malfunction events in which the device was reportedly leaking.5 events 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: h10 5 previously reported events are included in this follow-up record.Product return status 5 devices were received.Event confirmation status 5 reported events were not confirmed.Evaluation results 5 devices had no problem found.

• Brand Name: SYSTEM 7 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: 9244989
• MDR Text Key: 175090753
• Report Number: 0001811755-2019-03397
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327064803
• UDI-Public: 07613327064803
• Combination Product (y/n): N
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7207000000
• Device Catalogue Number: 7207000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1