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

Catalog Number 4203000000

Device Problem Unintended System Motion (1430)

Patient Problem No Patient Involvement (2645)

Event Date 04/29/2015

Event Type  malfunction  

Event Description

It was reported during service at manufacturer facility that device is running in wrong mode.It oscillated when forward trigger was pressed.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported during service at manufacturer facility that device is running in wrong mode.It oscillated when forward trigger was pressed.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

Through service, the service technician found that the device oscillated when it was supposed to run in the forward direction.Upon disassembly, a non-stryker asic motor controller and motor were found.The asic motor controller and motor were replaced along with other suggested components.Device was returned to the customer after passing the final inspection.

Manufacturer Narrative

Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

• Brand Name: SYSTEM 5 SINGLE 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: 4792360
• MDR Text Key: 5839199
• Report Number: 0001811755-2015-01865
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4203000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2002
• 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