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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA 3X75MM RT W BRNG C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA 3X75MM RT W BRNG C Back to Search Results
Catalog Number 114813
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 04/10/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was loosening of the ulna. The in-vivo length of patient service for the implant was 9. 8 months. The healthcare professional indicated there was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device was disposed of at the hospital and not made available to djo surgical for examination. A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part. All critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met. The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review. This event is deemed as non-product related. The root cause for this event was the patient was non-compliant and loosened the ulna by lifting a concrete blocks. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to the patient being non-complainant; he loosened his ulna by lifting a center block.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA 3X75MM RT W BRNG C
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
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
MDR Report Key6555853
MDR Text Key149379789
Report Number1644408-2017-00336
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2019
Device Catalogue Number114813
Device Lot Number679020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/09/2017 Patient Sequence Number: 1
Treatment
(B)(4), LOT 679020
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