MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 22.2MM X 40MM; IMPLANT

Catalog Number 6226-2-240

Device Problems Mechanical Problem (1384); Material Separation (1562)

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

Event Date 04/04/2014

Event Type  malfunction  

Event Description

When the centrax was taking out from the white net, the green clip was caught in the white net and the locking ring separated from the centrax.The green clip and locking ring was loaded to the centrax by hand and the centrax was locked the head with clamp.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was discarded and was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.A complaint history review could not be performed as no device specific failure modes were reported.Visual, dimensional and functional analysis could not be performed as the device was not returned.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No device-specific failure modes were identified in the reported event as the device was implanted.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

When the centrax was taking out from the white net, the green clip was caught in the white net and the locking ring separated from the centrax.The green clip and locking ring was loaded to the centrax by hand and the centrax was locked the head with clamp.

• Brand Name: CENTRAX DURATION 22.2MM X 40MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3776454
• MDR Text Key: 16013169
• Report Number: 0002249697-2014-01538
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2014

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 Expiration Date: 12/31/2016
• Device Catalogue Number: 6226-2-240
• Device Lot Number: A11S518
• Other Device ID Number: STERILE LOT# MSDKR23A4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 04/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other