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 Problems Disassembly (1168); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2013

Event Type  malfunction  

Event Description

The system 5 single trigger rotary handpiece was returned to stryker instruments for service, and during functional evaluation it was noted that the handpiece continually runs and the straight pin fell out.There was no patient involvement and no adverse consequences associated with the device.

Manufacturer Narrative

Failure analysis is ongoing; additional information may be submitted once the results analysis is complete.

Event Description

The system 5 single trigger rotary handpiece was returned to stryker instruments for service, and during functional evaluation it was noted that the handpiece continually runs.There was no patient involvement and no adverse consequences associated with the device.

Manufacturer Narrative

Removed reference to straight pin falling out.The straight pin is an internal component which would be contained within the handpiece.There is no safety risk of disassembly.

• 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: 3557547
• MDR Text Key: 4217140
• Report Number: 0001811755-2014-00059
• 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: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4203000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2006
• 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