MAUDE Adverse Event Report: ARTHREX, INC. 35MM CENTRAL SCREW, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	35MM CENTRAL SCREW, MODULAR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via phone that an ar-9560-24-2 baseplate and an ar-9561-35s central screw had an issue.During a reverse total shoulder procedure on (b)(6) 2023, when the surgeon was inserting the baseplate with the screw inside the patient, the screw broke off the baseplate into the glenoid.Both devices were removed from the patient, and all fragments were retrieved.Another baseplate ar-9560-24-4 with lot number 15030027 and another screw ar-9561-30s with lot # 14977751 was used to complete the procedure successfully with no impact to the patient.Both devices are available for return.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual evaluation, it was noted that the edges around the hex area of the interior of the screw are damaged.It looks like abrasion marks were produced with the matting part.Possible failure could be caused by excessive force or improper placement of the device.Also, a discoloration mark was observed between the threads.The cause remains undetermined.

• Brand Name: 35MM CENTRAL SCREW, MODULAR
• 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: 16386020
• Report Number: 1220246-2023-06300
• Device Sequence Number: 14879533
• Product Code: PHX
• UDI-Device Identifier: 00888867296589
• UDI-Public: 00888867296589
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/04/2023

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: 35MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-35S
• Device Lot Number: 15003159
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown