MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 10° FULL AUG, OB; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 24MM BASEPLATE, 10° FULL AUG, OB

Device Problems Material Separation (1562); Positioning Problem (3009)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2022 by a sales representative via email that an ar-9580-2410 mgs baseplate and ar-9582-25 modular post would not seat and were unable to be re-compressed.This was discovered during a case with no patient harm.Per facility: "after compressing the mgs augmented baseplate and the modular post together, the implant was inserted into the glenoid.It was not seating, and when removed, the two pieces came apart.We were then unable to re-compress them and forced to open new implants.".

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: 24MM BASEPLATE, 10° FULL AUG, OB
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 15577555
• MDR Text Key: 306323633
• Report Number: 1220246-2022-05584
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867341630
• UDI-Public: 00888867341630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193372
• 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: 10/10/2022

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: 24MM BASEPLATE, 10° FULL AUG, OB
• Device Catalogue Number: AR-9580-2410
• Device Lot Number: 1231072206
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/11/2022
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1