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

Model Number UNI GLENOID-PERIPHERAL LOCK SCRW

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/24/2020

Event Type  Injury  

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.

Event Description

It was reported that during implant to secured the baseplate, the ar-9145-36 screw broke off at the head.The distal end remains in the patient and the baseplate is secured with two other screws.The case was a reverse total shoulder.Update info 04/07/2020: the site was predrilled with an ar-9145k peripheral screw drill, 2.5 drill bit and a stryer drill.There was no torque indicator used.

Manufacturer Narrative

Complaint confirmed, the screw broke in two, the returned fragment is 11mm long.Likely causes include improper bone prep, misaligned insertion, prying/leveraging the device during insertion.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• Type of Device: PHX SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9963761
• MDR Text Key: 188489553
• Report Number: 1220246-2020-01794
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057739
• UDI-Public: 00888867057739
• Combination Product (y/n): N
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-36
• Device Lot Number: 18.01605
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other