MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NSE FOOTSWITCH; DRIVER, WIRE, AND BONE DRILL, MANUAL

Model Number 5400007000

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2020

Event Type  malfunction  

Event Description

It was reported that the pedal was sticking, presenting a risk of running after no longer activated.No patient involvement was reported.

Manufacturer Narrative

Follow-up report submitted to document device evaluation results.

Event Description

It was reported that the pedal was sticking, presenting a risk of running after no longer activated.No patient involvement was reported.

• Brand Name: NSE FOOTSWITCH
• Type of Device: DRIVER, WIRE, AND BONE DRILL, MANUAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10537378
• MDR Text Key: 207045678
• Report Number: 0001811755-2020-02393
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 07613154879205
• UDI-Public: 07613154879205
• Combination Product (y/n): N
• PMA/PMN Number: K040369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5400007000
• Device Catalogue Number: 5400007000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1