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

Model Number	5407-120-900A
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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 not available for evaluation.1 device investigation type has not yet been determined.Additional information: 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 reportedly overheated.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.Supplemental rationale: 3 previously reported events are included in this follow-up record.Product return status: 3 devices were not available for evaluation.
Event or Problem Description
This report summarizes 3 malfunction events in which the device reportedly overheated.2 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.

• Brand Name: MIS ANGLED 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
• MDR Report Key: 12203814
• Report Number: 3015967359-2021-01592
• Device Sequence Number: 4376799
• Product Code: HBE
• UDI-Device Identifier: 07613327402223
• UDI-Public: 07613327402223
• 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): 10/26/2021

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: 5407-120-900A
• Device Catalogue Number: 5407120900A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1