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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC CONDYLE KIT W/ HEXALOBULA

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ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC CONDYLE KIT W/ HEXALOBULA Back to Search Results
Catalog Number 114700
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 07/12/2016
Event Type  Injury  
Event Description
Revision surgery: due to the screw in the discovery condyle breaking; the surgeon replaced the condlyes and ulna bearing.
 
Manufacturer Narrative
The reason for this revision surgery was the screw in the discovery condyle broke. The length of in-vivo service is unknown since the original surgery date was not provided with the complaint and could not be established. The manufacturing date would indicate the product was in-vivo less than 6 years. 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. 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 (b)(4) for examination. A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing history of this part. All critical dimensions 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. The root cause of this event was a screw break in the discovery condyle after no more than six years patient use. The root cause for the screw breaking was not reported. The scope of this investigation is limited without having the parts available to (b)(4) for evaluation. Other conditions relating to this event could not be determined with confidence. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC CONDYLE KIT W/ HEXALOBULA
Manufacturer (Section D)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer (Section G)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
5128346255
MDR Report Key5857295
MDR Text Key51502547
Report Number1644408-2016-00532
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00888912224833
UDI-Public(01)00888912224833
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051975
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 07/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2020
Device Catalogue Number114700
Device Lot Number129380
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2010
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: 08/09/2016 Patient Sequence Number: 1
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