MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4205000000

Device Problems Unintended Power Up (1162); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported during set up before a procedure at user facility, the handpiece is overheating and it is running on its own once connected with the battery.The procedure was completed successfully using back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported during set up before a procedure at user facility that the handpiece is overheating and it is running on its own once connected with the battery.The procedure was completed successfully using back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.Failure analysis in progress.

Manufacturer Narrative

The reported event, handpiece is overheating and runs on its own, was confirmed.Device was repaired and returned to the customer after passing the final inspection.

• Brand Name: SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 4561198
• MDR Text Key: 5475759
• Report Number: 0001811755-2015-00735
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972367
• 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: 02/03/2015

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: 4205000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 03/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2004
• 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