MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ACET WINDOW TRIAL 50MM; INSTRUMENT

Catalog Number 2208-2050

Device Problems Material Distortion (2977); Material Integrity Problem (2978)

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

Event Date 06/09/2015

Event Type  malfunction  

Event Description

Doctor trialed with an acetabular window trial and found threads to be stripped.Surgeon was able to remove with a hemostat.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding thread damage involving a trident window was reported.The event was confirmed.Method & results: -device evaluation and results: a visual inspection confirms the reported thread damage.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been similar previous reported events.Conclusions: the event is related to complaints investigated under a capa.The capa identified the potential for cross-threading of the trial and mating cutting edge impactor/positioner during assembly which could contribute to thread damage over time.As a result, this device was made obsolete and a new design with different material was launched.Corrective action/preventive action: this event is associated with a capa which was initiated in may, 2004.The capa identified the potential for cross-threading of the trial and mating cutting edge impactor/positioner during assembly which could contribute to thread damage over time.As a result, a design change was implemented on march-2005 to change the material.Devices with the new material include an ¿a¿ suffix to the catalog number.The old design was made obsolete on september-2005.

Event Description

Doctor trialed with an acetabular window trial and found threads to be stripped.Surgeon was able to remove with a hemostat.

• Brand Name: TRIDENT ACET WINDOW TRIAL 50MM
• Type of Device: INSTRUMENT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4892816
• MDR Text Key: 6833192
• Report Number: 0002249697-2015-02209
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

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: 2208-2050
• Device Lot Number: 11883201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2004
• 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
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 73