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

Catalog Number 04.01.0162

Device Problem Material Deformation (2976)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

Visual inspection performed by medacta shoulder r&d project manager on 24 october 2023: the prongs are confirmed to be massively deformed.Given the entity and the type of damage, the deformation likely occurred during the screw removal with use of a clamp.The root cause is identified in the use of the wrong instrument, "glenoid polyaxial screwdriver - non-retentive", for the screw insertion.No action is suggested.Batch review performed on 03 october 2023: lot 2246832: 49 items manufactured and released on 25-jan-2023.Expiration date: 2028-01-03.No anomalies found related to the problem.To date, 35 items of the same lot have been sold with no similar reported event during the period of review.Additional device involved batch review performed on 03 october 2023 reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot 2304638: 70 items manufactured and released on 14-apr-2023.Expiration date: 2028-03-25.No anomalies found related to the problem.To date, 52 items of the same lot have been sold with no similar reported event during the period of review.

Event Description

During the surgery, the prongs of two glenoid polyaxial screws were deformed, during the insertion phase while using the glenoid polyaxial screwdriver - non-retentive.The bone was hard.The glenoid polyaxial locking screw - l26 was replaced with another screw, while the glenoid polyaxial locking screw - l34 was reamed down with airtome cutter.Delay time was 40 - 50 min.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34
• Type of Device: SHOULDER GLENOID POLYAXIAL 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18019680
• MDR Text Key: 326694507
• Report Number: 3005180920-2023-00828
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706490
• UDI-Public: 07630040706490
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/27/2023

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 Catalogue Number: 04.01.0162
• Device Lot Number: 2246832
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2023
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian