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

Model Number 540-00-000

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

Patient Problem No Code Available (3191)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

2nd revision surgery - due to unknown reason.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was unknown.The previous surgery and the surgery detailed in this event occurred 1.4 years 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 devices were disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to unknown reasons.There were no findings during this evaluation that indicate the reported devices were defective.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 event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 3X75MM LT W BRNG C
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 10503084
• MDR Text Key: 206104987
• Report Number: 1644408-2020-00840
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00190446137610
• UDI-Public: (01)00190446137610
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2020
• Device Model Number: 540-00-000
• Device Catalogue Number: 114812
• Device Lot Number: 033820
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114812, LOT 033820; 114904 LOT 547800; 114904, LOT 547800; 540-00-000 LOT 70487
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR