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

Catalog Number 5100004000

Device Problems Unintended System Motion (1430); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

It was reported that during set up at the user facility the tps handpiece cord was overheating and caused the handpiece to continue to spin.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device will not be returned; it is not possible to determine the cause of the reported malfunction without an evaluation of the device.The device will not be returned for evaluation.

Event Description

It was reported that during set up at the user facility the tps handpiece cord was overheating and caused the handpiece to continue to spin.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

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

• Brand Name: TPS HANDPIECE CORD
• 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: 3609385
• MDR Text Key: 4197831
• Report Number: 0001811755-2014-00355
• Device Sequence Number: 1
• Product Code: DZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2014

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 Operator: Health Professional
• Device Catalogue Number: 5100004000
• Device Lot Number: 07061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 02/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2007
• 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