MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34; SHOULDER GLENOID POLYAXIAL LOCKING SCREW

Catalog Number 04.01.0162

Device Problem Fracture (1260)

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

Event Date 01/24/2024

Event Type  Injury  

Event Description

During the primary shoulder surgery, one of the glenoid polyaxial screw broke during the initial insertion (04.01.10.0281 used).The surgeon tried to back it out or seat it all the way, but eventually decided to cut the screw off and break it down and was able to seat the glenosphere.There was a 40-minute delay and the surgery was completed successfully.Four glenoid polyaxial locking screws were placed: 34mm superior (broken), 14mm anterior, 14mm posterior, 26mm inferior.

Manufacturer Narrative

Batch review performed on 25 january 2024 lot 2314172: 50 items manufactured and released on 18-jul-2023.Expiration date: 2028-jun-26.No anomalies found related to the problem.To date, 23 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: during the primary implant of a reverse shoulder arthroplasty, the superior glenoid polyaxial screw broke during the initial insertion.The surgeon reported that the correct screwdriver was used, according to the surgical technique.He was not able to remove or fully seat the fragment of the screw, so decided to cut it off, leaving the tip into the bone.However, he reported successful seating of the glenosphere.The available x-rays shows an implant well positioned, with the residual screw fragment visible in the superior aspect of the glenoid bone.The reason of the breakage is difficult to detect with the available information: the cause is likely multifactorial, possibly related to the quality of the bone, the strength during insertion or the direction.If the residual screw fragment does not interfere with the glenosphere (as it is reported), we do not expect secondary adverse effects, as it seems completely surrounded of bone.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18766812
• MDR Text Key: 336104674
• Report Number: 3005180920-2024-00047
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0162
• Device Lot Number: 2314172
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2023
• 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: 84 YR
• Patient Sex: Female