MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP FOOTSWITCH; UNIT, OPERATIVE DENTAL

Model Number	5100008000
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 1 malfunction event in which the device ran without user activation.- 1 event 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.Reported events: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was not labeled for single-use.1 device was not reprocessed or reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device ran without user activation.1 event had no patient involvement; no patient impact.1 event had 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: 1 event was originally reported for this failure mode during the reporting quarter; however, 1 event was inadvertently excluded.2 reported events are included in this follow-up record.Product return status: 2 devices were received.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 2 events were previously reported during the reporting period; however, 1 previously reported event in this report was also reported under mfr report # 3015967359-2023-00384.1 previously reported event is included in this follow-up record.Product return status: 1 device was received.
Event or Problem Description
This report summarizes 1 malfunction event in which the device ran without user activation.1 event had no patient involvement; no patient impact.

• Brand Name: FOOTSWITCH
• Common Device Name: UNIT, OPERATIVE DENTAL
• 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: 16261803
• Report Number: 3015967359-2023-00112
• Device Sequence Number: 19917931
• Product Code: EIA
• UDI-Device Identifier: 04546540971272
• UDI-Public: 04546540971272
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• 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): 01/24/2024

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: 5100008000
• Device Catalogue Number: 5100008000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2022
• Supplement Date Received by Manufacturer: 12/31/2022; 12/31/2022
• Initial Report FDA Received Date: 01/29/2023
• Supplement Report FDA Received Date: 04/25/2023; 01/24/2024
• 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