MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNI GLENOID-PERIPHERAL LOCK SCRW
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/15/2024, it was reported by a sales representative via phone that qty.2 of an ar-9145-36 arthrex universal glenoid peripheral locking screw 36 mm had an issue during a reverse total shoulder arthroplasty on (b)(6) 2024.When the surgeon was trying to lock the first screw into an ar-9120-01pc revers glenoid porous coat baseplate, s, he felt the screw was not locking down correctly.He backed out the screw, as this had occurred in a previous case which had been previously reported, and discarded the device.He then used a second ar-9145-36 arthrex universal glenoid peripheral locking screw 36 mm with the same batch number, which he felt was also not locking down correctly.However, it was down enough and affixed correctly to leave it inside the patient.The surgeon felt the two screws were not biting correctly into the baseplate and wanted to report the complaint.There was no issue observed with the base plate.The procedure was completed successfully with no harm to the patient.There was no case delay, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9145-36 arthrex universal glenoid¿ - peripheral locking screw 36 mm serial/batch number (b)(6) was received for evaluation.A visual inspection revealed missing material at the hex of the screw head.Dents, scratches and material peeling off were noted on the side of the screw head.Nicks and scratches were observed on the threaded body of the screw.The screw shows signs of cross-threading on both the body and the head.Functional testing was performed with a good know plate found that the screw doesn't completely seats on the bushing's holes.The screw¿s critical dimensions were measured according to drawing 070123 at revision 2.For component 070123-03, no nonconformities were found.Screw# 2 : 40° ± 2° (38°- 42°) result: 41°.Ø 5.4 ±.1 (5.3 - 5.5) result: 5.4.Ø 4.5 ±.1 (4.4 - 4.6) result: 4.6.Ø 3.5 ±.1 (3.4 - 3.6) result: 3.5.5.8 ±.1 (5.7 - 5.9) result: 5.8.Ø 2.3 ±.1 (2.2 -2.4) result: 2.4.R 0,7 ±.2 (0.5 - 0.9) result: 0.7.Ø 4.5 ±.1 (4.4 - 4.6) result: 4.5.L1= 36 ±.3 (35.7 -36.3) result: 36.Ø 4.7 + 0 /-.03 (4.67 - 4.70) result: 4.70.The most likely cause of the reported failure is misuse due to a misaligned insertion.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• 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: 20543928
• Report Number: 1220246-2024-08276
• Device Sequence Number: 20787577
• Product Code: PHX
• UDI-Device Identifier: 00888867057739
• UDI-Public: (01)00888867057739(11)240301(17)290228(10)23.05074
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• 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): 03/07/2025

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: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-36
• Device Lot Number: 23.05074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2024
• 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