MAUDE Adverse Event Report: ARTHREX, INC. REVERS 36MM CA ADAPTER ASSEMBLY; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number REVERS 36MM CA ADAPTER ASSEMBLY

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

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 Description

On (b)(6)2024, it was reported by a sales representative via email that an ar-9502-36arca univers revers ca humeral head adapter 36 was attempted to be attached to the cup.Unable to marry the two products successfully.This was discovered during a rtsa revision case where a ca head was implanted.The case was completed with another ar-9502-36arca with no patient harm.Additional information received 2/28/24: the reason for the revision surgery was that the patient had stryker hardware in from a previous rtsa which was infected.The case was delayed roughly 10 minutes.

• Brand Name: REVERS 36MM CA ADAPTER ASSEMBLY
• Type of Device: 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: 18889987
• MDR Text Key: 337533771
• Report Number: 1220246-2024-01438
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867230378
• UDI-Public: 00888867230378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REVERS 36MM CA ADAPTER ASSEMBLY
• Device Catalogue Number: AR-9502-36ARCA
• Device Lot Number: 22.04047
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1