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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 30MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

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ARTHREX, INC. 30MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG Back to Search Results
Model Number 30MM CENTRAL SCREW, MODULAR
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
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 not confirmed, the baseplate and post were returned assembled correctly and could not be disassembled.No abnormalities observed.
 
Event Description
On 12/13/2021, it was reported by a sales representative via email that an ar-9560-4 baseplate and an ar-9561-30s central screw were not implanted correctly because the morse taper fell apart.This was discovered during a procedure.Surgeon completed case successfully without further issue by using a new baseplate and central screw.After receiving additional information on 12/14/2021, sales representative has confirmed that case was completed using an ar-9560-24 from lot number 12732669 and an ar-9561-30s from lot number 9549.Nothing broke inside the patient and case was completed without further issues.
 
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Brand Name
30MM CENTRAL SCREW, 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 Key19097244
MDR Text Key340039709
Report Number1220246-2024-02007
Device Sequence Number1
Product Code PHX
UDI-Device Identifier00888867296572
UDI-Public00888867296572
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/12/2024
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 Number30MM CENTRAL SCREW, MODULAR
Device Catalogue NumberAR-9561-30S
Device Lot Number9549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2022
Initial Date Manufacturer Received 12/13/2021
Initial Date FDA Received04/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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