MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L26; SHOULDER POLYAXIAL LOCKING SCREW

Catalog Number	04.01.0160
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 may 2024 lot 2336610: (b)(4) items manufactured and released on 29-nov-2023.Expiration date: 2028-11-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The prongs of the glenoid polyaxial locking screw deformed during insertion.The surgeon had to cut off the head and leave the broken screw inside the patient's bone to complete the surgery.Bone was very hard.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L26
• Common Device Name: SHOULDER 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: 19237810
• Report Number: 3005180920-2024-00282
• Device Sequence Number: 8142594
• Product Code: PHX
• UDI-Device Identifier: 07630040706476
• UDI-Public: 07630040706476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.01.0160
• Device Lot Number: 2336610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• 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: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian