MAUDE Adverse Event Report: ARTHREX, INC. REVERS 39MM CA ADAPTER ASSEMBLY; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	REVERS 39MM CA ADAPTER ASSEMBLY
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 6/23/2022, it was reported by a sales representative via phone that during a revision procedure, both the ar-9502-29arca, revers 39mm ca adapter assembly and, ar-9550-29rca, revers ca humeral head, 50/19, were having issues seating.The surgeon had them in the suture cup and then after trial reduction, they were augmenting the subs cap and did an internal rotation.The adaptor and head, both, popped out of the cup.The head became stuck on the post and the adaptor would not sit in the cup.In order to be safe it was agreed that a new implant be used to complete the case.The surgeon had no issues after swapping out the implants, however, it did add time to the case.The revision was a conversion from a revers total shoulder procedure to a hemi due to the mgs being loose and not holding in the glenoid.Additional information requested.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed.(1) unpackaged ar-9502-39rca stuck to (1) unpackaged ar-9660-r were received for evaluation.Visual inspection of the devices revealed dents and scratches on both devices, likely from attempts to separate them.Separation of the two devices was unsuccessful.It was noted that the device used to attempt to extract the humeral head adapter from the humeral head is not the appropriate instrument.The ar-9660-r was inserted on the wrong side of the threading, and a more appropriate device would have been the glenosphere forceps.The cause for the devices becoming stuck is thus attributed to misuse from the user due to inappropriate instrumentation choice.

• Brand Name: REVERS 39MM CA ADAPTER ASSEMBLY
• Common Device Name: SHOULDR PROSTH HEMI- HUM UNCEM
• 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: 19290662
• Report Number: 1220246-2024-03124
• Device Sequence Number: 7143185
• Product Code: HSD
• UDI-Device Identifier: 00888867230385
• UDI-Public: 00888867230385
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K151527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: REVERS 39MM CA ADAPTER ASSEMBLY
• Device Catalogue Number: AR-9502-39ARCA
• Device Lot Number: 17.01297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown