MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L22; REVERSE SHOULDER SCREW

Model Number	04.01.0159
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 may 2021: lot 184567: (b)(4) items manufactured and released on 25-apr-2019.Expiration date: 2024-04-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain due to the screw placed in the glenoid in the primary hitting a nerve.8 months after the primary, the surgeon revised the screw with a shorter screw.The surgeon also revised the glenosphere, humeral reverse metaphysis, and humeral reverse liner since the joint loosened up intraoperatively unexpectedly.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L22
• Common Device Name: REVERSE SHOULDER SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12057829
• Report Number: 3005180920-2021-00510
• Device Sequence Number: 17137678
• Product Code: PHX
• UDI-Device Identifier: 07630040706469
• UDI-Public: 07630040706469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: 04/10/2024
• Device Model Number: 04.01.0159
• Device Catalogue Number: 04.01.0159
• Device Lot Number: 184567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention