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

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.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC 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 Key: 6555853
• MDR Text Key: 149379789
• Report Number: 1644408-2017-00336
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013042
• Number of Events Reported: 1
• 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 Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 114813
• Device Lot Number: 679020
• 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 Received: 07/03/2017
• 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