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

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

Device Problem Defective Device (2588)

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

Event Date 09/07/2022

Event Type  malfunction  

Event Description

On (b)(6) /2022, it was reported by a sales representative via sems that (2) ar-9503m-03c humeral inserts are damaged.This was discovered during an unspecified time, with no patient effect reported.

Manufacturer Narrative

This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: HUM INSERT M/39+3 TO FIT IN 39 CUP CONST
• 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: 19193722
• MDR Text Key: 341717093
• Report Number: 1220246-2024-02473
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867061262
• UDI-Public: 00888867061262
• 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: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2024

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: HUM INSERT M/39+3 TO FIT IN 39 CUP CONST
• Device Catalogue Number: AR-9503M-03C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 04/26/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1