MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW; DISC ULNA BEARING KIT

Model Number V

Device Problems Break (1069); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 04/26/2016

Event Type  Injury  

Event Description

Revision surgery - due to the poly wearing out; causing the pin/screw to break.The surgeon performed a bearing surface exchange.

Manufacturer Narrative

The reason for this revision surgery was the pin/screw broke.The original surgery date was not provided and could not be determined, therefore; the length of in-vivo service 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 device history record and investigation history was not conducted since a lot number was not provided and could not be established for the original explanted part.A search of the djo surgical patient database was not conducted since biomet products and surgeries are not included in the djo historical surgical records at this time.No complaint history is available at this time.Zimmer biomet was contacted and was unable to provide any additional information concerning this revision surgery.Additional information is necessary for zimmer biomet to retrieve original surgery information and the information is unavailable at this time.The event is the result of poly wear and a subsequent screw breakage after an un-specified length of in-vivo service.This is an isolated incident and there is no reason to believe a general risk is present.The complaint evaluation is limited in scope since the part (s) associated with the complaint was not returned to djo surgical for evaluation.No other conditions relating to this event could be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA BEARING KIT
• 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
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 5676698
• MDR Text Key: 45827595
• Report Number: 1644408-2016-00301
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: V
• Device Catalogue Number: 114800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR