MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC ULNA 3X155MM LT W BRNG C

Catalog Number 114818

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 02/16/2017

Event Type  Injury  

Manufacturer Narrative

Surgeon kept.

Event Description

Revision surgery - due to the left ulna component breaking.

Manufacturer Narrative

The reason for this revision surgery was the left ulna component broke. The actual length of in-vivo patient service for this product is unknown as the original surgery date was not provided or could be established. There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery. There are no reported pre-existing patient health conditions. 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 surgeon kept the device it has not been made available to djo surgical for examination. A review of the device history record (dhr) was not conducted since a lot number was not provided or determined during the complaint evaluation. A search of the device investigation produced no anomalies or evidence of a product issue. Multiple searches of the djo surgical records and patient database revealed no additional information concerning this event. Zimmer-biomet was contacted for additional information through an invoice search and reported they have no additional information to report for this evaluation. This complaint will be closed with the lot unknown pending receipt of additional information. This complaint is deemed to be non-product related. No other conditions, root cause, relating to this event could be determined with confidence. The surgeon reported no issues associated with the explanted product. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 3X155MM LT W BRNG C
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• 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: 6411194
• MDR Text Key: 70142805
• Report Number: 1644408-2017-00151
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225182
• UDI-Public: (01)00888912225182
• 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

• Type of Report: Initial,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 114818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/16/2017
• 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 Treatment Data

Date Received: 03/16/2017 Patient Sequence Number: 1