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
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2024-00047
• Device Sequence Number: 20768250
• Product Code: PHX
• UDI-Device Identifier: 07630040706490
• UDI-Public: 07630040706490
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.01.0162
• Device Lot Number: 2314172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Female