MAUDE Adverse Event Report: ARTHREX, INC. 5.5X28MM PERIPHERAL SCREW, LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number 5.5X28MM PERIPHERAL SCREW, LOCKING

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 01/11/2024

Event Type  Injury  

Event Description

On 1/17/2024, it was reported by a sales representative via sems-06459681 that an ar-9660-r central post extractor got stuck in the implant during implant removal.This was discovered during a revision reverse total shoulder procedure on (b)(6) 2024.No further information was reported.Additional information received on 1/31/2024: the original procedure occurred on (b)(6), 2021.Due to pain, the patient underwent revision surgery.During the revision surgery on (b)(6) 2024, an ar-9503s-03 humeral insert, an ar-9555-09 univers revers spacer, an ar-9563-16 peripheral locking screw, an ar-9563-20 peripheral locking screw, an ar-9563-24 peripheral locking screw, an ar-9563-28 peripheral locking screw, an ar-9564-2436 glenosphere, an ar-9580-2410-2 baseplate, and an ar-9582-25 modular post were explanted.Only an ar-9501-10s univers revers apex stem and an ar-9502f36rcpc suture cup remained from the original surgery.To complete the revision surgery, an ar-9503s-03c humeral insert, an ar-9555-12 univers revers spacer, an ar-9560-24-4 baseplate, an ar-9561-30s central screw, an ar-9563-16 peripheral locking screw, an ar-9563-20 peripheral locking screw, (2) ar-9563-28 peripheral locking screw, and an ar-9564-2436-inf glenosphere were successfully implanted.The case was not delayed, and no further issues were reported.

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.

• Brand Name: 5.5X28MM PERIPHERAL SCREW, LOCKING
• 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: 18695275
• MDR Text Key: 335298165
• Report Number: 1220246-2024-00934
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Report Date: 02/13/2024

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 Model Number: 5.5X28MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-28
• Device Lot Number: 2021000577
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2021
• 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
• Patient Outcome(s): Other