MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MIS HUB; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	5407-120-900
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
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; 28 events were reported for this quarter.Product return status; 28 devices were evaluated based on historical data analysis.Additional information; 28 devices were not labeled for single-use.28 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 28 malfunction events in which the device reportedly overheated.6 events had no patient involvement; no patient impact.19 events had patient involvement; no patient impact.3 events which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.
Event or Problem Description
This report summarizes 28 malfunction events in which the device reportedly overheated.- 6 events had no patient involvement; no patient impact.- 19 events had patient involvement; no patient impact.- 3 events which had a mild injury, illness or impairment which can be treated with minimal or no intervention.

• Brand Name: MIS HUB
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16808017
• Report Number: 3015967359-2023-01003
• Device Sequence Number: 5992569
• Product Code: HBE
• UDI-Device Identifier: 07613327096439
• UDI-Public: 07613327096439
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 28
• 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): 07/27/2023

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: 5407-120-900
• Device Catalogue Number: 5407120900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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