MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number UNI GLENOID-PERIPHERAL LOCK SCRW

Device Problems Difficult to Insert (1316); Defective Device (2588); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

It was reported that during a universe reverse shoulder surgery when trying to insert the 30 mm screw into the baseplate & bone the screwdriver screwed through, as the screw was too tight.The screwdriver was defective and the drivers became distorted.The screw head had twisted, could no longer be moved and could not be fully inserted.The surgeon knocked the screw flat and inserted the glenosphere.No part of the devices broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same devices.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Manufacturer Narrative

Complaint not confirmed, the screw was not returned and no picture provided.The x-ray provided did not provide enough information to confirm or investigate the complaint.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12896739
• MDR Text Key: 282814743
• Report Number: 1220246-2021-04016
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057722
• UDI-Public: 00888867057722
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 12/22/2021

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
• Device Operator: Health Professional
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-30
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 12/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1