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

Catalog Number 04.01.0110

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 08 august 2023: lot 2300354: 100 items manufactured and released on 04-july-2023.Expiration date: 2028-06-19.Analysis by the manufacturing department identified that the issue was confirmed and it was due to the laser marking fixture was fixed and turned on the machine of 180° in comparison to the instructions.Following the analysis we are conducting a removal of the lot 2300354 reference 04.01.0110, humeral reverse metaphysis +0mm/0°.

Event Description

The humeral reverse metaphysis +0mm/0 had a reversed positioning of the laser marking indications of the 155° and 145° (the 155° marking was aligned with the indexing pin on the inferior side of the implant).All the other laser marking indications (reference, logo, lot, height and retroversion) were on the inverted side, too.The surgery was completed using a backup device.

Manufacturer Narrative

Visual inspection performed by washing & packaging manager: the laser marking have been performed on the opposite side of the implant rim (moved of 180° respect to the drawing) the lot has been laser marked on 28 april 2023 on the laser machine n°486.The instruction for marking reports the correct positioning of the fixing gauge and the marking program is correct and aligned to the instruction.The error were: 1.The fixing gauge was 180° turned during the marking with respect to the marking instruction; 2.The fixing gauge has the marking instruction to verify the correct position of laser marking but it was not check during marking.Furthermore the laser marking check was missed.The instruction of control doesn't allow a safe check to the operator, there are no reference to know if the position of the marking is correct.The instruction of control, fixing guage and laser marking program will be revised.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°
• Type of Device: HUMERAL REVERSE METAPHYSIS +0MM/0°
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17570817
• MDR Text Key: 321404716
• Report Number: 3005180920-2023-00660
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706179
• UDI-Public: 07630040706179
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0110
• Device Lot Number: 2300354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2023
• 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