MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 8/8/2023, it was reported by a sales representative via phone that an ar-9503m-03 univers revers humeral insert, part of a loaner set with an unknown part number, had an issue during a reverse total shoulder procedure on (b)(6) 2023.When the surgeon was trying to use it, the implant would not fit and snap into the suture cup.No piece broke off inside the patient.Another second ar-9503m-03 univers revers humeral insert with an unknown lot number was used in the procedure, and it would snap right in.This caused a case delay of over 15 minutes.It could not be confirmed if additional anesthesia was administered to the patient.The procedure was then completed successfully with no patient harm.
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.
Additional Manufacturer Narrative
Additional information: complaint allegation is not confirmed.One unpackaged ar-9503m-03 univers revers humeral insert lot number: 22.03114 was received for evaluation.Visual inspection noted no problems with the device.Functional testing was performed with a known good ar-9502-39lpc univers revers cup and it was noted that the ar-9503m-03 univers revers humeral insert was able to snap into the univers revers cup and securely attach to the ar-9502-39lpc univers revers cup as intended.No problem found.

• Brand Name: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• 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: emily shafer ; 8009337001
• MDR Report Key: 17699600
• Report Number: 1220246-2023-07808
• Device Sequence Number: 20713287
• Product Code: PHX
• UDI-Device Identifier: 00888867061255
• UDI-Public: 00888867061255
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/08/2025

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: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-03
• Device Lot Number: 22.03114
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 01/08/2025
• 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