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

Catalog Number	800-05-045
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/28/2016
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: EMPOWR PS KNEETM BOX CUT GUIDE, SIZE 6
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5823423
• Report Number: 1644408-2016-00502
• Device Sequence Number: 10910092
• Product Code: HAO
• UDI-Device Identifier: 00888912545143
• UDI-Public: (01)00888912545143
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 800-05-045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 10/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR