MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE; INSERT, 3D EX SZ 6LT 11MM

Model Number	391-11-706
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Primary surgery - there was a size 8 insert inside a size 6 box.
Additional Manufacturer Narrative
Djo global (b)(4) stated that during a primary surgery, a size 6 left 3dknee tibial insert, 391-11-706, box was opened but there was a size 8 right 3dknee tibial insert within the packaging.The event caused a 20 minute delay in surgery.No adverse event or hazardous situation was reported.Another suitable device was not available but the surgery was completed as intended.Upon review of the device history record (dhr), work order # (b)(4), size 6 left 3dknee tibial insert, 391-11-706, 292g1910 the lot contained 12 units and was processed through the clean room on (b)(6) 2015 through (b)(6) 2015.The work order was stamped hot however there were no anomalies documented or noted on the work order, there was no scrap or label reprints documented and the product lot was sterilized using hydrogen peroxide gas plasma, sterility lot #e151112f.The lot was released to finished goods on 18-nov-2015.Upon review of the device history record (dhr), work order # (b)(4), size 8 right 3dknee tibial insert, 392-11-708, 339g1045 the lot contained 12 units and was processed through the clean room on (b)(6) 2015 through (b)(6) 2015.The work order was stamped hot however there were no anomalies documented or noted on the work order, there was no scrap or label reprints documented and the product lot was sterilized using hydrogen peroxide gas plasma, sterility lot #e151112i.The lot was released to finished goods on 18-nov-2015.The gas plasma sterility cycle is 36 minutes long, with each cycle for the calendar day indicated by the last letter of the cycle number.Lot e151112f (391-11-706, 292g1910) would have been processed approximately 2 hours before lot e151112i (392-11-708, 339g1045).This is the first complaint received against this lot number.It is possible that these products were mixed during processing in the clean room.Hhe-(b)(4) will assess any possible health hazard and required containment actions.Capa (b)(4) will further investigate root cause, and corrective action.

• Brand Name: 3DKNEE
• Common Device Name: INSERT, 3D EX SZ 6LT 11MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 6451313
• Report Number: 1644408-2017-00199
• Device Sequence Number: 18986206
• Product Code: OIY
• UDI-Device Identifier: 00888912119221
• UDI-Public: (01)00888912119221
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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 Model Number: 391-11-706
• Device Catalogue Number: 391-11-706
• Device Lot Number: 292G1910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1