MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER GENERAL GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE; INSTRUMENT FOR SHOULDER SURGERY

Model Number	04.01.10.0284
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon had difficulty implanting the glenosphere.Looking at the x-rays, a fragment of the screwdriver was noticed.The surgeon removed the fragment after removing the implant.A new glenosphere was used to complete the surgery.There was a 30 minutes delay, total surgery time 130 minutes.Also, the glenosphere screw thread was deformed.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.One prong is confirmed to be broken.The screwdriver shaft was manufactured in aisi 420 mod as per drawing revision in force at the time of production.The material was modified from aisi 420 mod to aisi 420 b in order to improve the mechanical resistance of the instrument and prevent further occurrence of such events.The glenosphere does not show any signs of damage or discolouration.The glenosphere screw shows circular scratches on the outer surface of both the screw head and the main shaft.In addition the thread is damaged, likely due to malalignment while tightening the screw.It is not possible to determine whether the glenosphere was incorrectly seated on the baseplate due to the presence of the fragment.With the information at hand, it is not possible to identify the root cause of the event.Batch review performed on 19 november 2021.Lot 1854513: 32 items manufactured and released on 22-nov-2018.No anomalies found related to the problem.To date, 3 similar events have been reported on this lot.Additional component involved in the event: reverse shoulder system 04.01.0167 glenosphere 32xø22 (k170452) lot.189859.Lot 189859: 79 items manufactured and released on 10-apr-2019.Expiration date: 2024-03-10.No anomalies found related to the problem.To date, no items of the same lot have been sold.

• Brand Name: SHOULDER GENERAL GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE
• Common Device Name: INSTRUMENT FOR SHOULDER SURGERY
• 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: 12868652
• Report Number: 3005180920-2021-00916
• Device Sequence Number: 5442042
• Product Code: LXH
• UDI-Device Identifier: 07630971211902
• UDI-Public: 07630971211902
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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

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: 04.01.10.0284
• Device Catalogue Number: 04.01.10.0284
• Device Lot Number: 1854513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian