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

Model Number	04.01.0199
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 11 september 2020 lot 1908166: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation: rsa is performed with bone grafting to place the glenoid component in the desired position.During rehabilitation, the grafts are displaced and the glenoid component with them.One screw broke.For the time being, no revision is undertaken.It is very likely that the mobilization of the grafts happened during rehabilitation.The screw fracture is inevitable in such a case and possibly helped to reduce the consequences of the displacement.No reason to suspect a faulty device.Other devices involved in the event: reverse shoulder system 04.01.0154 glenoid baseplate ¿27x15 lot.1904754 batch review performed by medacta regulatory affairs department on 11 september 2020 lot 1904754: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0174 glenosphere 42x27 lot.188492; batch review performed by medacta regulatory affairs department on 11 september 2020 lot 188492: (b)(4) items manufactured and released on 27-jun-2019.Expiration date: 2024-06-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The baseplate screw broke after the primary surgery (performed on (b)(6) 2020), and the baseplate and glenosphere mobilized, it is possible that the screw broke during the rehabilitation.The patient has got an mss short stem reverse with bone-graft during the primary surgery.If everything remains as it is now, the patient will not be revised.If the x-ray image will show a deterioration, the revision will be made.The prosthesis is not luxated.The patient has no pain and is doing well.In this time a revision surgery is no planned, in the next two weeks, the patient will have a control visit.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L34
• Common Device Name: SHOULDER SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10655595
• Report Number: 3005180920-2020-00688
• Device Sequence Number: 3552125
• Product Code: PHX
• UDI-Device Identifier: 07630040719926
• UDI-Public: 07630040719926
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K181826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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: 11/30/2024
• Device Model Number: 04.01.0199
• Device Catalogue Number: 04.01.0199
• Device Lot Number: 1908166
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other