MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW L26; SHOULDER GLENOID POLYAXIAL LOCKING SCREW

Catalog Number 04.01.0160

Device Problem Material Fragmentation (1261)

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

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 07 march 2019: lot 182293: (b)(4) items manufactured and released on 04-sep-2018.Expiration date: 2023-08-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: screw breakage during implantation.The screw was replaced by a new one and surgery was completed successfully.No clinical consequence is expected for this event.

Event Description

The surgeon may have misplaced the screw during surgery and the head of the screw broke.He decided to use another screw to complete the case.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW L26
• Type of Device: SHOULDER GLENOID POLYAXIAL LOCKING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8403057
• MDR Text Key: 139075314
• Report Number: 3005180920-2019-00134
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706476
• UDI-Public: 07630040706476
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/08/2019

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: 08/23/2023
• Device Catalogue Number: 04.01.0160
• Device Lot Number: 182293
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2018
• 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