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

Model Number	5400200000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
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: three events were reported for this quarter.Product return status: one device was received.Two device investigation types have not yet been determined.Additional information: three devices were not labeled for single-use.Three devices were not reprocessed or reused.
Event or Problem Description
This report summarizes three malfunction events in which the device reportedly overheated.Three 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.Supplemental rationale: 3 previously reported events are included in this follow-up record.Product return status: 2 devices were received.1 device investigation type has not yet been determined.
Event or Problem Description
This report summarizes 3 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.
Event or Problem Description
This report summarizes 6 malfunction events in which the device reportedly overheated.6 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.Supplemental rationale: 3 events were previously reported during the reporting quarter; however, 3 previously reported events were included under mfr report # 3015967359-2022-01487 but should be included under this report.6 previously reported events are included in this follow-up record.Product return status: 6 devices were received.

• Brand Name: CORE, MAESTRO DRILL
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15102078
• Report Number: 3015967359-2022-01450
• Device Sequence Number: 5438110
• Product Code: HBB
• UDI-Device Identifier: 04546540469113
• UDI-Public: 04546540469113
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2023

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
• Device Model Number: 5400200000
• Device Catalogue Number: 5400200000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 06/30/2022; 06/30/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 10/24/2022; 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown