MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP; SHOULDR PROSTH, REVERSE CONFIG

Model Number HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP

Device Problem Fitting Problem (2183)

Patient Problem Failure of Implant (1924)

Event Date 08/04/2023

Event Type  malfunction  

Event Description

On 8/8/2023, it was reported by a sales representative via phone that an ar-9503m-03 univers revers humeral insert, part of a loaner set with an unknown part number, had an issue during a reverse total shoulder procedure on (b)(6) 2023.When the surgeon was trying to use it, the implant would not fit and snap into the suture cup.No piece broke off inside the patient.Another second ar-9503m-03 univers revers humeral insert with an unknown lot number was used in the procedure, and it would snap right in.This caused a case delay of over 15 minutes.It could not be confirmed if additional anesthesia was administered to the patient.The procedure was then completed successfully with no patient harm.

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: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• 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: emily shafer ; 8009337001
• MDR Report Key: 17699600
• MDR Text Key: 322850205
• Report Number: 1220246-2023-07808
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867061255
• UDI-Public: 00888867061255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-03
• Device Lot Number: 22.03114
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/08/2023
• 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