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

Model Number	30MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-9561-30s univers revers, modular glenoid system, central screw, modular 30 mm, was received for investigation.Visual evaluation with science scope magnifier of the central screw, modular showed some damage on the hex of the screw, but no visual issues were found on the thread of the screw.
Event or Problem Description
On 07/28/2022, it was reported by a sales representative via email that an ar-9560-24-4 baseplate and an ar-9561-30s central screw disassociated from each other during insertion.This was discovered during an arthroplasty reverse shoulder procedure on (b)(6) 2022.Additional information requested on (b)(6) 2022.Additional information provided on 08/05/2022: the patient had extremely hard bone.An ar-9618-24 was used over a 2.8mm guide pin.After sufficient reaming with primary glenoid reamer an ar-9620-10d was drilled over 2.8 guide pin to a positive stop.Once drilling was completed an ar-9621-30t, in conjunction with the manual driver shaft ar-9631 was inserted to a positive stop, then removed.After preparation of the glenoid was achieved the mgs baseplate was inserted with the baseplate inserter, the ar-9623 threaded.The baseplate disassociated right before backside seating of the baseplate into the prepped glenoid surface.The case was completed by using a new ar-9560-24-4 lot: 14939747 and ar-9561-30s lot: 14950583 with no patient harm.

• 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: 19089619
• Report Number: 1220246-2024-01989
• Device Sequence Number: 7112214
• 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
• Report Date (Section B): 04/11/2024

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: 14950583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown