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

Model Number	30MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 3/5/2024, it was reported by a sales representative via phone that an ar-9560-24-4 baseplate and an ar-9561-30s central screw came apart during insertion.This was discovered during a revers total shoulder procedure on (b)(6) 2024.The press was used to press down both devices together.The physician assistant verified that it was between the minimum and maximum.However, when the surgeon inserted the baseplate and central screw in the patient, they came apart.The surgeon was not far into the surgery yet and was able to remove the baseplate and central screw easily.The surgeon was not confident in the integrity of the devices and did not want to try to put them back together again; instead, the case was completed using a new ar-9560-24-4 baseplate and an ar-9561-30s central screw.The patient was not affected.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9561-30s was received for investigation.Functional testing found that the device attaches to the returned ar-9560-24-4 batch 15130123.However, because of the damage to the screw hex, the base plate got stuck.The visual evaluation found that the hex was damaged, revealing cracks and nicks.A mark was observed at the porous side of the screw, a possible sign of excessive force to unscrew it from the base plate.The most likely cause for the reported failure is user error following the device's surgical technique.According to dfu-0189 at revision 5.E.Warnings.8.Failure to achieve the appropriate torque requirements when tightening locking screws may result in the premature loosening of the device.

• 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: jared engle ; 8009337001
• MDR Report Key: 18914252
• Report Number: 1220246-2024-01503
• Device Sequence Number: 6892990
• Product Code: PHX
• UDI-Device Identifier: 00888867296572
• UDI-Public: 00888867296572
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/05/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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