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

Model Number 508-32-101

Patient Problem Foreign Body In Patient (2687)

Event Date 09/05/2023

Event Type  malfunction  

Event Description

Procedure: right reverse total shoulder arthroplasty and biceps tenodesis.Screw was broken off in the patient's right shoulder.A new screw was opened.Part of screw did stay in the patient's shoulder and the other part was removed.

• Brand Name: GLENOID HEAD NEUTRAL W/RETAINING SCREW
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ENCORE MEDICAL, L.P.
• MDR Report Key: 18247550
• MDR Text Key: 329588713
• Report Number: MW5148649
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 508-32-101
• Device Lot Number: 862C4027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic