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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 24MM +4 LAT BASEPLATE, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

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ARTHREX, INC. 24MM +4 LAT BASEPLATE, MODULAR; SHOULDR PROSTH, REVERSE CONFIG Back to Search Results
Model Number 24MM +4 LAT BASEPLATE, MODULAR
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2022
Event Type  malfunction  
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.Complaint confirmed.Upon visual evaluation, it was noted that the central screw was not fully seated on the baseplate.It was also noted that the description provided reported resistance encountered and then a loud cracking that was heard.Per the surgical technique, there is a hex feature that must be aligned between the baseplate and the central screw resulting in a tactile coupling and allowing the taper to engage.When the hex feature is not aligned properly and the taper is attempted to be engaged, the hex feature will break and compress blocking the central screw from being able to fully seat.The most likely cause can be attributed to use error due to not following the surgical technique as required.
 
Event Description
It was reported that during an inverse shoulder prosthesis surgery with mgs the surgeon experienced issues with the screw and the plate.When the surgeon merged the baseplate and screw he experienced first a resistance, then loud cracking.After that the screw could be inserted completely.According to the surgeon the screw was slightly tilted and therefore not 100% stable.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
 
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Brand Name
24MM +4 LAT BASEPLATE, MODULAR
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 Key19020793
MDR Text Key339141978
Report Number1220246-2024-01777
Device Sequence Number1
Product Code PHX
UDI-Device Identifier00888867296473
UDI-Public00888867296473
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K173900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/02/2024
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 Number24MM +4 LAT BASEPLATE, MODULAR
Device Catalogue NumberAR-9560-24-4
Device Lot Number14774693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2023
Initial Date Manufacturer Received 12/05/2022
Initial Date FDA Received04/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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