MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; SCREW, LOCKING BONE, RSP, 5X18

Catalog Number	506-03-118
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2023-01705; 506-03-114, s801 - device cracked/broke, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery due to the broken screw in the baseplate and broken screw was left in patient.

• Brand Name: DJO SURGICAL
• Common Device Name: SCREW, LOCKING BONE, RSP, 5X18
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 20872785
• Report Number: 1644408-2024-01876
• Device Sequence Number: 8839241
• Product Code: PHX
• UDI-Device Identifier: 00888912024549
• UDI-Public: 00888912024549
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K041066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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 Catalogue Number: 506-03-118
• Device Lot Number: 832C2262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 506-03-114 LOT: 831C2539.; 508-32-103 LOT: 864C6391.; 508-32-204 LOT: 769P3114.; 509-02-432 LOT: 953W1394.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female