MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE; INSERT, 3D EX SZ 6RT 9MM

Catalog Number 392-09-706

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2015

Event Type  Injury  

Event Description

Primary surgery - during surgery the locking screw would not engage, the surgeon believed the tibial insert to stripped.

Manufacturer Narrative

The lot number was initially reported as: catalog# 392-09-706, lot 59604793.Changed to: catalog 392-09-706, lot 328g1054.The catalog number did not change.Manufacturer narrative: the reason for this complaint was to report an implant malfunction during a primary knee surgery.The agent reported, "during surgery the locking screw would not engage." the healthcare professional indicated a significant adverse event occurred.There was no delay in surgery and another suitable device was available for use.The surgery was completed as intended.The complaint part was returned to djo surgical under rma e916798.The tibial insert is in generally new condition, except for some tool marks on the three snap features, very likely due to the surgeon's effort to remove the product from the tibial baseplate.The thread on the attachment screw is stripped along its entire length.A review of the device history records (dhrs) showed no non-conforming material reports associated with this product.(b)(4).This investigation is limited in scope because the mating tibial baseplate was not returned to djo surgical.However, the fact that surgeon was able to assemble a second tibial insert to the baseplate without difficulty suggests that the baseplate is not the root cause of the complaint.The fact that the attachment screw thread is stripped along its entire length indicates that the screw was likely over-torqued, or was driven past some debris in the baseplate thread that was subsequently cleared from the thread before the second tibial insert was placed successfully.The surgical technique for 3d knee specifies that a torque-limiting driver with a nominal limit of 45 in-lbs be used to secure the attachment screw.If a non torque-limiting driver were used, or if the torque-limiting driver were significantly out of calibration, this could explain the stripped attachment screw.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The dhr evidences that all critical dimensions and specifications were met when the product was released from djo surgical, and the surgery was completed as intended.

• Brand Name: 3DKNEE
• Type of Device: INSERT, 3D EX SZ 6RT 9MM
• 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: 4865490
• MDR Text Key: 5813340
• Report Number: 1644408-2015-00362
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2019
• Device Catalogue Number: 392-09-706
• Device Lot Number: 328G1054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2014
• 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): Other
• Patient Age: 42 YR