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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA 4X75MM RT W BRNG C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA 4X75MM RT W BRNG C Back to Search Results
Catalog Number 114823
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to the patient suffering from a fracture. The previous surgery and the revision detailed in this investigation occurred over 2 years apart. There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery. There are no reported pre-existing patient health conditions. Initial or prolonged hospitalization was required. 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 implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event. The device was within its expiration date at the time of use during the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The root cause of this complaint was a revision surgery due to the patient suffering from a fracture. There were no findings during this investigation that indicate that the reported device was defective. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to the patient suffering from a fracture. The patient required a longer ulna stem to be placed in.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA 4X75MM 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 Key7113156
MDR Text Key270297439
Report Number1644408-2017-01159
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 01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number114823
Device Lot Number671910
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 Received01/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2014
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: 12/13/2017 Patient Sequence Number: 1
Treatment
114700, LOT 803430
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