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
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Instrument failure - patella drill got wedged into the drill guide.
Additional 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
• Common Device Name: 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
• Report Number: 1644408-2023-00821
• Device Sequence Number: 20032615
• Product Code: JWH
• UDI-Device Identifier: 00190446365891
• UDI-Public: 00190446365891
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K212941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 802-05-107
• Device Catalogue Number: 802-05-107
• Device Lot Number: 388620L02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 802-05-103 LOT: N/A; 802-05-103 LOT: 254340L01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male