MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO FIXED DURAGUARD; MOTOR, DRILL, PNEUMATIC

Catalog Number	5400210059
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.  reported events - 2 events were reported for this quarter.Product return status -1 device was received for evaluation.    1 device was not available to stryker for evaluation.Evaluation status - 1 device evaluation is in progress.Additional information - 2 devices are not labeled for single-use.2 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device reportedly overheated.2 events had no patient involvement; no patient impact.
Event or Problem Description
This report summarizes 2 malfunction events in which the device reportedly overheated.2 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale corrected data: 2 total events were initially reported.2 previously reported events are included in this follow-up record.Product return status 1 device was received.1 device was not available for evaluation.  evaluation status 1 reported event was confirmed during testing.- 1 device was found to be affected by corrosion.  additional information 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.

• Brand Name: PD SERIES MAESTRO FIXED DURAGUARD
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8014578
• Report Number: 0001811755-2018-02091
• Device Sequence Number: 1755736
• Product Code: HBB
• UDI-Device Identifier: 04546540469212
• UDI-Public: 04546540469212
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 5400210059
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2018
• Supplement Date Received by Manufacturer: 06/02/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1