MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDR PROSTH, REVERSE CONFIG

Model Number UNI GLENOID-PERIPHERAL LOCK SCRW

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

Event Description

It was reported that during an eclipse with universal glenoid surgery during implantation of the universal glenoid baseplate the inferior peripheral screw got jammed.When trying to screw it in, the head of the screwdriver broke off and got stuck in the screw head.This had to be removed using the operace system.The screw head broke off in the process.The rest of the screw remained in the patient and the baseplate was left as it was.The inlay was then placed on top and the surgery was completed as normal.There was no harm for patient, operator or third party.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• Type of Device: SHOULDR PROSTH, REVERSE CONFIG
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 18935788
• MDR Text Key: 338078612
• Report Number: 1220246-2024-01557
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057746
• UDI-Public: 00888867057746
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-42
• Device Lot Number: 22.02532
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1