MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34

Catalog Number 04.01.0162

Device Problems Bent (1059); Entrapment of Device (1212)

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

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Preliminary investigation performed ba r&d product manager: the picture confirms that the screw was not fully seated in the baseplate hole and that the prongs were protruding off the screw seat.In addition the deformation of the prongs and the removal of the inner screw are confirmed.The hole appears to be slightly off centre considering screw seat.Clinical evaluation performed by medical affairs director: an intraoperative problem was reported after rsa.From the description of the event, no clinical origin can be discerned.It is very likely that no clinical consequence should be expected either.Batch review performed on 09-may-2018.Lot 165153: (b)(4) items manufactured and released on 15-december-2016.Expiration date: 2021-11-03.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.

Event Description

During the glenoid polyaxial locking screw insertion some prongs of the outer screw were bent.The outer screw remained stuck in the baseplate and it could not be removed, the surgeon removed all screw prongs, using pliers, and complete the surgery successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34
• Type of Device: POLYAXIAL 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, 6874 ; SZ 6874
• MDR Report Key: 7506729
• MDR Text Key: 108550707
• Report Number: 3005180920-2018-00316
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706490
• UDI-Public: 07630040706490
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2021
• Device Catalogue Number: 04.01.0162
• Device Lot Number: 165153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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