MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DJO SURGICAL; GUIDE, SURGICAL, INSTRUMENT

Model Number	804-02-468
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Scrub tech notified nurse of broken trial implant.All of the pieces from broken trial implant removed from surgical field.

• Brand Name: DJO SURGICAL
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 9151212
• Report Number: 9151212
• Device Sequence Number: 14126763
• Product Code: FZX
• UDI-Device Identifier: 00888912147729
• UDI-Public: (01)00888912147729
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/16/2019
• Report Date (Section F): 09/16/2019

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: 804-02-468
• Device Lot Number: 281889L01
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 100
• Date Report Sent to FDA: 09/16/2019