MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID PRIMARY REAMER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number UNIVERSAL GLENOID PRIMARY REAMER

Device Problems Dull, Blunt (2407); Defective Device (2588)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint confirmed, the primer reamer ring is missing and was not returned.The reamer edges are dull and dented.The cause of the broken ring is undetermined, however a likely cause is user-applied mechanical forces.A likely cause of the dull edges is wear and tear.

Event Description

It was reported that during shoulder prosthesis surgery the ring at the milling machine is defective.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with the same device used anyway.It was not necessary to switch the surgical technique or do a second surgery.No further information received.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: UNIVERSAL GLENOID PRIMARY REAMER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12393061
• MDR Text Key: 270545037
• Report Number: 1220246-2021-03581
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867057623
• UDI-Public: 00888867057623
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNIVERSAL GLENOID PRIMARY REAMER
• Device Catalogue Number: AR-9126RP
• Device Lot Number: 04511905
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1