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 Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/04/2014

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure conducted at the user facility, the device was not running in the correct mode; it was running in forward when in reverse mode.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported that during a surgical procedure conducted at the user facility, the device was not running in the correct mode; it was running in forward when in reverse mode.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

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

Manufacturer Narrative

It was confirmed during device evaluation that the device was not running in the wrong mode.Rather, it was found that the reverse trigger had to be pulled multiple times in order for the forward trigger to function.As a result, there was no safety risk to the patient or user.Upon disassembly, a cracked trigger housing was found, which can contribute to the reported event.

• 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: 4127499
• MDR Text Key: 4944496
• Report Number: 0001811755-2014-03418
• 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: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• 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: 09/08/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2002
• 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