MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW; DISC ULNA 4X75MM LT W BRNG C

Catalog Number 114822

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as fracture and loosening.The previous surgery date is unknown.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 (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices 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 a fracture and loosening.There were no findings during this investigation that indicate that the reported device was defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.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 event.There are multiple factors that may contribute to an event 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 - patient had a periphrastic fracture and loosening.One of the screws was missing from the condyle.The surgeon found the loose screw and removed as well.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 4X75MM LT W BRNG C
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd; austin texas 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd; austin texas 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 8940857
• MDR Text Key: 156398768
• Report Number: 1644408-2019-00789
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 114822
• Device Lot Number: 834930
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR