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

Model Number	30MM CENTRAL SCREW, MODULAR
Medical Device Problem Codes	Positioning Failure (1158); Compatibility Problem (2960)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/14/2023, it was reported by a sales representative via e-mail that an ar-9561-30s univers revers¿ modular glenoid system had an issue marrying the central screw to the ar-9560-24-2 base plate.This occurred during a reverse total shoulder on (b)(6) 2023, where the central screw did not marry to the base plate, and the metal ended up getting a little deformed.They followed all the correct steps from the technique guide and made sure the screw married the base plate correctly before tightening down with the clamp.No additional information was provided, and additional information has been asked.
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.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-9561-30s batch, 15100631, was received for investigation.Functional testing with the returned mating part ar-9560-24-2 batch 15097595 was not performed due to the damage to the screw hex; the base plate could get stuck.The visual evaluation found that the hex was damaged, with nicks, a possible sign of excessive force to screw/unscrew it from the base plate.The most likely cause of the reported failure is user error.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.

• Brand Name: 30MM CENTRAL SCREW, MODULAR
• Common Device Name: 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: emily shafer ; 8009337001
• MDR Report Key: 18477995
• Report Number: 1220246-2024-00224
• Device Sequence Number: 12361854
• Product Code: PHX
• UDI-Device Identifier: 00888867296572
• UDI-Public: 00888867296572
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• 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,Followup
• Report Date (Section B): 08/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: 30MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-30S
• Device Lot Number: 15100631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown