MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TRIAL NECK; ORIGIN STEM, TRIAL NECK: SIZE HIGH OFFSET

Catalog Number 111-182-021

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

Instrument failure - origin high offset trial that says "ho" does not fully sit in broaches 14 and 15 like they should.Had to open another origin tray and that one had the "lat" and seemed to sit fully in the 14 and 15 broach outside of the patient.This delayed surgery as we had to get new trials on the broach and try different things.

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Manufacturer Narrative

1644408-2022-01133 was reassessed and determined to be non-reportable.

• Brand Name: TRIAL NECK
• Type of Device: ORIGIN STEM, TRIAL NECK: SIZE HIGH OFFSET
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15365299
• MDR Text Key: 299566994
• Report Number: 1644408-2022-01133
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 00190446348337
• UDI-Public: (01)00190446348337
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111-182-021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male