MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 2.5X84MM LT BOND CT

Catalog Number 114806

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 07/23/2019

Event Type  Injury  

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 months apart.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, shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product that may have contributed to the reported event.The device 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 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 was the source or had a direct connection with the patient's infection.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.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.

Event Description

Revision surgery- due to an infection.

Manufacturer Narrative

Correction to 2nd paragraph: the reason for this revision surgery was due to an infection.The previous surgery and the surgery detailed in this investigation occurred 3 months apart.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, shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product that may have contributed to the reported event.The device was within its expiration date at the time of 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 an infection.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's infection.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.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.

Manufacturer Narrative

D10 - adding concomitant part 600-10-100.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 2.5X84MM LT BOND CT
• 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: 8923307
• MDR Text Key: 155329673
• Report Number: 1644408-2019-00783
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2020
• Device Catalogue Number: 114806
• Device Lot Number: 271090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2015
• 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: 114912 LOT 388170; 540-00-004 LOT 72850; 600-10-100 COBALT-G MV BONE CEMENT 40GM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female