MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L22; SHOULDER POLYAXIAL SCREW

Model Number	04.01.0159
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
2 glenoid polyaxial locking screw prong heads broke while the surgeon was trying to insert them in the glenoid baseplate (1x 22mm, 1x 26mm).Finally a glenoid bone fracture occurred and the surgeon decided to switch to an anatomical system.The bone was very hard.
Additional Manufacturer Narrative
Batch review performed on 28 july 2022 lot 2118698: lot 2118698: (b)(4).Additional components implanted: batch review performed on 28 july 2022 reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot.2118701: lot 2118701: (b)(4).Batch review performed on 28 july 2022 reverse shoulder system 04.01.0151 glenoid baseplate ø24.5x15 (k170452) lot.2117651: lot 2117651: (b)(4).

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L22
• Common Device Name: SHOULDER POLYAXIAL SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15208238
• Report Number: 3005180920-2022-00600
• Device Sequence Number: 2068614
• Product Code: PHX
• UDI-Device Identifier: 07630040706469
• UDI-Public: 07630040706469
• 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): 08/11/2022

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 Model Number: 04.01.0159
• Device Catalogue Number: 04.01.0159
• Device Lot Number: 2118698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2022
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian