MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46

Model Number	04.01.0202
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 july 2022 lot 1908169: 62 items manufactured and released on 18-dec-2019.Expiration date: 2024-dec-07.No anomalies found related to the problem.To date, 5 items of the same lot have been sold with no similar reported event during the period of review.Clinical evalution performed by medical affairs department: revision performed 7 months after the previous revision rsa due to implant failure in a male patient.According to report, the baseplate mobilized and that may be the reason why two polyaxial screws broke, as visible in the radiographic images.An allograft was used.It is possible that the allograft was not osseointegrated causing the mobilization of the baseplate during some movement of the arm.From previous revision, a fragment of previous screw remained inside the patient, which likely it was not possible to remove without harming the patient.No other details are specified regarding the previous revision.No reason to suspect a defective implant at the origin of this adverse event.Visual inspection performed by r&d shoulder manager: two polyaxial screws are confirmed to be broken at about 30-35 mm from the screw head.The breakage likely occurred in bending following failure of the bone graft and implant mobilization.The remaining explants have no major signs of damage and do not show any scratches of particular interest.Additional items involved in the event, batch review performed on 15 july 2022 reverse shoulder system 04.01.0203 glenoid polyaxial non-locking screw - l50 (k181826) lot.187770 lot 187770: 64 items manufactured and released on 16-jan-2019.Expiration date: 2023-dec-17.No anomalies found related to the problem.To date, 7 items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0301 grs baseplate - ø24.5x20 +3mm lot.2106796 (item not registered in usa) lot 2106796: 64 items manufactured and released on 16-dec-2021.Expiration date: 2026-nov-29.No anomalies found related to the problem.To date, 25 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery performed 7 months after the previous revision surgery due to baseplate mobilization and two polyaxial screws breakage (no trauma reported).It is possible that the glenoid component was too lateralized causing overstress and screws breakage.An allograft was used.The patient previously had a revision on 21.12.2021 due to trauma, details unknown.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46
• Common Device Name: GLENOID POLYAXIAL NON-LOCKING 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: 15112258
• Report Number: 3005180920-2022-00595
• Device Sequence Number: 17509030
• Product Code: PHX
• UDI-Device Identifier: 07630040719957
• UDI-Public: 07630040719957
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 07/27/2022

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 Expiration Date: 12/07/2024
• Device Model Number: 04.01.0202
• Device Catalogue Number: 04.01.0202
• Device Lot Number: 1908169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2019
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White