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

Catalog Number 5100007000

Device Problem Device Remains Activated (1525)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure the tps unidirectional footswitch was causing the handpiece to run on.The procedure was completed successfully utilizing back-up equipment.No delay, no medical intervention and no adverse consequences.

Manufacturer Narrative

A follow up report will be filed after the quality investigation has been completed.

Event Description

It was reported that during a procedure, the tps unidirectional footswitch was causing the handpiece to run on.The procedure was completed successfully utilizing back-up equipment.No delay, no medical intervention and no adverse consequences.

Manufacturer Narrative

During the device evaluation, the engineering technician found the magnet in the pedal had become loose during the device inspection.The device was discarded by the manufacturer.

• Brand Name: TPS UNIDIRECTIONAL FOOTSWITCH
• Type of Device: DRIVER, WIRE, AND BONE DRILL, MANUAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3786452
• MDR Text Key: 4377436
• Report Number: 0001811755-2014-01592
• Device Sequence Number: 1
• Product Code: DZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5100007000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1