MAUDE Adverse Event Report: ARTHREX, INC. 5.5X20MM PERIPHERAL SCREW, LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	5.5X20MM PERIPHERAL SCREW, LOCKING
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
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 02/29/2024, it was reported by a sales representative via e-mail that an ar-9563-20 univers revers¿ modular glenoid system locking threads were defective.This occurred during a procedure where another locking screw was used in its place, and there were no adverse effects.
Event or Problem Description
Additional information provided 3/4/24: the procedure performed was a rtsa on (b)(6) 2024.The case was completed by using an ar-9563-16, 16mm locking peripheral screw.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9563-20 univers revers¿ modular glenoid system peripheral locking screw batch number: 15115648 was received for investigation.The batch number for the device returned does not match the batch number for the complaint device reported.Visual evaluation of the device noted slight damage to the threads, the threads on the head of the screw were noted to be bent and the threads on the body of the screw were slightly warped.The inner diameter of the screw head was measured using a microvu and found that the inner diameter of the head was.233 which is in tolerance of the specified.232 +.002 -.001.The inner diameter of the screw body was measured using a microvu and found that the inner diameter of the body was.118 which is in tolerance of the specified.118 +.000 -.005.The outer diameter of the screw body was measured using a microvu and found that the outer diameter of the body was.213 which is in tolerance of the specified.217 +.000 -.005.The pitch of the threads of the screw body was measured using a microvu and found that the pitch of the threads of the screw body was.069 which is in tolerance of the specified.069 ±.005.The length of the screw was measured using a caliper and found that the length of the screw was.785 which is in tolerance of the specified.787 ±.012.Functional testing was not performed due to the damage to the threads of the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• Brand Name: 5.5X20MM PERIPHERAL SCREW, LOCKING
• 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: jared engle ; 8009337001
• MDR Report Key: 18835353
• Report Number: 1220246-2024-01288
• Device Sequence Number: 7245965
• Product Code: PHX
• UDI-Device Identifier: 00888867296824
• UDI-Public: 00888867296824
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/04/2024

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: 5.5X20MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-20
• Device Lot Number: 15162312
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2023
• 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