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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS
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TORNIER INC. LATITUDE ELBOW PROSTHESIS Back to Search Results
Catalog Number 9030394
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2017
Event Type  malfunction  
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or is related to a death or injury.
 
Event Description
It was reported that the device broke during use and the surgeon had to use another company's guide rod to complete the surgery.The surgeon had to make a window to fish it back through.The issue increased the patient's surgery time by one hour and required the use of additional anaesthesia.
 
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Brand Name
LATITUDE ELBOW PROSTHESIS
Type of Device
ELBOW PROSTHESIS
Manufacturer (Section D)
TORNIER INC.
10801 nesbit avenue south
bloomington MN 55437
Manufacturer Contact
dustin smith
10801 nesbit avenue south
bloomington, MN 55437
9529217121
MDR Report Key6692387
MDR Text Key79289402
Report Number3004983210-2017-00020
Device Sequence Number1
Product Code JDB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number9030394
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/21/2017
Initial Date FDA Received07/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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