MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CORE, MAESTRO DRILL WITH HANDSWITCH; MOTOR, DRILL, PNEUMATIC

Model Number	5400201000
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 3 events were reported for this quarter.Product return status: 2 devices were received.1 device investigation type has not yet been determined.Event confirmation status: 2 reported events were confirmed.Evaluation results: 2 devices were found to be affected by a loose lever assembly.3 devices were not labeled for single-use.3 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device ran without user activation.3 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.3 previously reported events are included in this follow-up record.Product return status 3 devices were received.
Event or Problem Description
This report summarizes 3 malfunction events in which the device ran without user activation.- 3 events had no patient involvement; no patient impact.

• Brand Name: CORE, MAESTRO DRILL WITH HANDSWITCH
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 10330231
• Report Number: 0001811755-2020-01945
• Device Sequence Number: 19047354
• Product Code: HBB
• UDI-Device Identifier: 04546540503947
• UDI-Public: 04546540503947
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• 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): 04/29/2021

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 Model Number: 5400201000
• Device Catalogue Number: 5400201000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1