MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°

Catalog Number 04.01.0110

Device Problem Component Missing (2306)

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

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 06 may 2019: lot 174653: (b)(4) items manufactured and released on 12-mar-2018.Expiration date: 2023-03-01.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.Preliminary investigation performed by (b)(4): the pictures underline that the screw is not the correct one but it is a screw used for knee implants.It is possible to hypothesize that inside the bag containing all the required screws (in the production site), there was a wrong screw and that it was not identified by the operator during the check phase, because this screw is very similar in terms of threading and dimensions to the shoulder screw.

Event Description

A wrong screw was found in the packaging of the metaphysis.The surgery was completed using a back-up screw.

Manufacturer Narrative

Visual inspection (b)(6) 28.11.2019: the screw is not the correct one but it is a screw used for knee implants.It is possible to hypothesize that inside the bag, containing the required screws (in the production site), there was a wrong screw and that it was not identified by the operator during the checking phase because this screw is very similar in terms of threading and dimensions to the shoulder screw.To avoid this occurrence the control instruction ic 08.10 has been updated adding the functional check with a torx screwdriver to recognize the right product.The wrong screw found in the packaging has a hexagonal head pocket that is not possible to couple with a torx screwdriver.Piece returned on 28.11.2019, we received the item from (b)(6) no email.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°
• Type of Device: HUMERAL REVERSE METAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8595279
• MDR Text Key: 145768211
• Report Number: 3005180920-2019-00353
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706179
• UDI-Public: 07630040706179
• Combination Product (y/n): N
• PMA/PMN Number: K173794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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: 03/01/2023
• Device Catalogue Number: 04.01.0110
• Device Lot Number: 174653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other