MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 5X75MM RT W BRNG C

Catalog Number 114833

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 08/10/2017

Event Type  Injury  

Event Description

Revision surgery - the ulna was loose due to infection of the patient.The surgeon removed with the condyle kit.The djo rep said the original surgery took place many years ago at a different hospital.

Manufacturer Narrative

The reason for this revision surgery was due to an infection.The date of the original surgery is unknown.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system.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.This investigation is limited in scope as limited information was provided to djo surgical (b)(4) for review.The lot number of the device(s) involved in this event was not provided.To adequately investigate this event, the part and/or lot number(s) are necessary.In addition to the lot and/or part number(s) not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied.The root cause of this complaint was a revision surgery due to an infection.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.With the limited information provided about the patient and the devices removed during the revision surgery, it is impossible to determine the source of the infection.Containment based on the information submitted with this complaint it is not possible as the agent was unable to supply the lot numbers.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 5X75MM 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: 6854953
• MDR Text Key: 85633859
• Report Number: 1644408-2017-00749
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225274
• UDI-Public: (01)00888912225274
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2017
• 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 Sequence Number: 1
• Treatment: 114700, LOT UNKNOWN
• Patient Outcome(s): Required Intervention