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

Catalog Number 114813

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/19/2012

Event Type  Injury  

Event Description

Reported incident - due to unknown reasons.Revision surgery date not given.

Manufacturer Narrative

The reason for this revision surgery was due to an infection.The previous surgery and the surgery detailed in this investigation occurred 3.8 months apart.This investigation is limited in scope as limited information was provided to djo surgical - austin for examination.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information is submitted at a future date, this investigation will be re-evaluated.A review of the implant device history records (dhr), shows that the reported component(s) used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device(s) 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 an infection.There were no findings during this investigation that indicate that the reported device(s) was the source or had a direct connection with the patient's infection.No other 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.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• 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
• MDR Report Key: 8437834
• MDR Text Key: 139369232
• Report Number: 1644408-2019-00200
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225151
• UDI-Public: (01)00888912225151
• Combination Product (y/n): N
• PMA/PMN Number: K013042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 114813
• Device Lot Number: 505000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700 LOT 428980; 114700, LOT 428980; 114905 LOT 872680; 114905, LOT 872680; 402283 LOT 846240; 402283, LOT 174810; 402283, LOT 348190; 402283, LOT 362140; 402283, LOT 846240; 114700, LOT 428980; 114905, LOT 872680; 402283, LOT 174810; 402283, LOT 348190; 402283, LOT 362140; 402283, LOT 846240
• Patient Outcome(s): Other; Required Intervention