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

Model Number	24MM BASEPLATE, 10° FULL AUG, OB
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem 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.".
Additional 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
• Common Device Name: 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
• Report Number: 1220246-2022-05584
• Device Sequence Number: 7300347
• Product Code: PHX
• UDI-Device Identifier: 00888867341630
• UDI-Public: 00888867341630
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K193372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/11/2022
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown