MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30; GLENOID LOCKING SCREW

Catalog Number 04.01.0161

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 02.Sep.2019.Lot 184569: 303 items manufactured and released on 15-jan-2019.Expiration date: 2023-12-05.No anomalies found related to the problem.To date, 65 items of the same lot have been already sold without any other similar reported event.

Event Description

During the primary reverse shoulder surgery and while inserting the 30mm glenoid polyaxial locking screw, the tabs on the screw head bent causing the screw not to seat or lock.The surgeon removed the screw and was able to successfully implant, seat and lock the new screw.There was no delay in the case and the surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30
• Type of Device: GLENOID LOCKING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9080726
• MDR Text Key: 213883720
• Report Number: 3005180920-2019-00779
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706483
• UDI-Public: 07630040706483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/18/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2023
• Device Catalogue Number: 04.01.0161
• Device Lot Number: 184569
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2019
• 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
• Patient Outcome(s): Other