MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE FOOTSWITCH; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	5402007000
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
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: 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 1 malfunction event in which the device had a sticky safety device that could lead to unintended power-up.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.Supplemental rationale corrected data: b5.
Event or Problem Description
This report summarizes 1 malfunction event in which the device was sticking.1 event had no patient involvement; no patient impact.
Event or Problem Description
This report summarizes 0 malfunction events in which the device had a sticky safety device that could lead to unintended power-up.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h10.1 event was previously reported during the reporting quarter; however: 1 event was reported in error.0 previously reported events are included in this follow-up record.H3 other text : event reported in this record in error.

• Brand Name: CORE FOOTSWITCH
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10329720
• Report Number: 0001811755-2020-01847
• Device Sequence Number: 812253
• Product Code: HBE
• UDI-Device Identifier: 07613327423631
• UDI-Public: 07613327423631
• 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): 01/29/2021

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: 5402007000
• Device Catalogue Number: 5402007000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020; 06/30/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 07/28/2020; 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1