MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR KNEE OFFSET PATELLA DRILL GUIDE, LARGE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 802-05-107

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Instrument failure - patella drill got wedged into the drill guide.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2023-00220; 802-05-107, s103 - fit.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.Rma examination: the instrument was returned to djo and after further examination, the drill and patella guide welded.

• Brand Name: EMPOWR KNEE OFFSET PATELLA DRILL GUIDE, LARGE
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 17243851
• MDR Text Key: 318264940
• Report Number: 1644408-2023-00821
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00190446365891
• UDI-Public: 00190446365891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 802-05-107
• Device Catalogue Number: 802-05-107
• Device Lot Number: 388620L02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2023
• 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
• Treatment: 802-05-103 LOT: N/A; 802-05-103 LOT: 254340L01
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male