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

Model Number UNI GLENOID-PERIPHERAL LOCK SCRW

Device Problems Break (1069); Entrapment of Device (1212); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/14/2021

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.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.

Event Description

It was reported that during screwing in of the device (ar-9145-30, lot 19.02683) the screwdriver (ar-9545-115-03) was bent and before the device was fully inserted the head of the device broke off.The broken off head of the device was retrieved from the patient, but the rest of the device remained inside the patient.According to the surgeon there was no harm for patient, operator or third party.The implantation of a universal glenoid surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

Complaint confirmed the ar-9145-30 screw broke.The proximal end fragment was returned and measured.352 in.Relevant features were not available to be measured and no additional damage was observed.The cause is undetermined.

• 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
• MDR Report Key: 11761339
• MDR Text Key: 250881705
• Report Number: 1220246-2021-02999
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057722
• UDI-Public: 00888867057722
• Combination Product (y/n): N
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• 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
• Device Lot Number: 19.02683
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/14/2021
• Patient Sequence Number: 1