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 Problems No Patient Involvement (2645); No Information (3190)

Event Date 06/30/2020

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: 12 events were reported for this quarter.Product return status: 1 device was received.11 device investigation types have not yet been determined.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 device had no problem found.12 devices were not labeled for single-use.12 devices were not reprocessed or reused.

Event Description

This report summarizes 12 malfunction events in which the device was reportedly leaking.1 event had no patient involvement; no patient impact.11 events had no information received.

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: b5, h10 12 previously reported events are included in this follow-up record.Product return status 12 devices were received.Event confirmation status 11 reported events were confirmed.1 reported event was not confirmed.Evaluation results 11 devices did not have a root cause established.1 device had no problem found.

Event Description

This report summarizes 12 malfunction events in which the device was reportedly leaking.- 12 events had no patient involvement; no patient impact.

• 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: 10331493
• MDR Text Key: 200641013
• Report Number: 0001811755-2020-01972
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327064803
• UDI-Public: 07613327064803
• Combination Product (y/n): N
• Number of Events Reported: 12
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• 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: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1