MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. EMPOWR KNEE; EMPOWR PS KNEETM BOX CUT GUIDE, SIZE 6

Catalog Number 800-05-045

Device Problems Component Falling (1105); Fracture (1260)

Patient Problem No Information (3190)

Event Date 06/28/2016

Event Type  malfunction  

Event Description

Revision surgery - due to the surgeon putting the box cut in, per surgical technique, and a medial condyle fractured significantly once the cuts and box chisel had been made.Fell off when removing the box cut.

Manufacturer Narrative

The reason for this complaint was to report that when the surgeon put the box cut in, per surgical technique, the medial condyle fractured significantly once the cuts and box chisel had been made.Fell off when removing the box cut during the primary surgery.The healthcare professional indicated there was a significant adverse event to the patient.There was a 5-10 minute delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device has not been made available to djo surgical for examination.The instrument lot number or revision was not reported, therefore, this instrument could not be linked to a specific device history record (dhr) or the actual date of manufacture could not be determined with confidence.Complaint database review showed that this is the first complaint against this part number.The root cause will be determined as part of corrective and preventative action (capa) (b)(4): the design of the captured box guide can create an instance where the surgeon is not completing the box cut on the side.When the surgeon the fully seats the chisel, the uncut bone can fracture.The reported condition could possibly be a result failure to follow proper surgical technique.

• Brand Name: EMPOWR KNEE
• Type of Device: EMPOWR PS KNEETM BOX CUT GUIDE, SIZE 6
• 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: 5823423
• MDR Text Key: 51232480
• Report Number: 1644408-2016-00502
• Device Sequence Number: 1
• Product Code: HAO
• UDI-Device Identifier: 00888912545143
• UDI-Public: (01)00888912545143
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 800-05-045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR