MAUDE Adverse Event Report: ENCORE MEDICAL L.P SCREW, RETAINING GLENOID HEAD RSP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 508-00-001

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2023

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 - 30 minute delay in surgery.

Manufacturer Narrative

See h4 the agent reported "this was a primary surgery.2 different torque screw drivers broke the set screw in the glenoid.We ended up wasting.5 implants because of this.Female 59 yrs." this event occurred during surgery, near the patient.No response was received by the surgeon.The surgery was completed as intended, with a thirty-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma examination: the instruments were returned to djo and after further examination, the tips of the torque driver are stripped.None of the implants came back with the instruments.

• Brand Name: SCREW, RETAINING GLENOID HEAD RSP
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 17981431
• MDR Text Key: 326392535
• Report Number: 1644408-2023-01530
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024617
• UDI-Public: 00888912024617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051075
• 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: 12/26/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 508-00-001
• Device Lot Number: 850C1396C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• 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: 506-03-126 LOT: 834C2162.; 508-00-001 LOT: 850C1396C.; 508-32-101 LOT: 862C4188.; 508-32-204 LOT: 769P2841.; 508-32-204 LOT: 769P2858.
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female