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

Catalog Number	04.01.0162
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection performed by medacta shoulder r&d project manager on 24 october 2023: the prongs are confirmed to be massively deformed.Given the entity and the type of damage, the deformation likely occurred during the screw removal with use of a clamp.The root cause is identified in the use of the wrong instrument, "glenoid polyaxial screwdriver - non-retentive", for the screw insertion.No action is suggested.Batch review performed on 03 october 2023: lot 2246832: 49 items manufactured and released on 25-jan-2023.Expiration date: 2028-01-03.No anomalies found related to the problem.To date, 35 items of the same lot have been sold with no similar reported event during the period of review.Additional device involved batch review performed on 03 october 2023 reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot 2304638: 70 items manufactured and released on 14-apr-2023.Expiration date: 2028-03-25.No anomalies found related to the problem.To date, 52 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
During the surgery, the prongs of two glenoid polyaxial screws were deformed, during the insertion phase while using the glenoid polyaxial screwdriver - non-retentive.The bone was hard.The glenoid polyaxial locking screw - l26 was replaced with another screw, while the glenoid polyaxial locking screw - l34 was reamed down with airtome cutter.Delay time was 40 - 50 min.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34
• Common Device Name: SHOULDER GLENOID POLYAXIAL 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: 18019680
• Report Number: 3005180920-2023-00828
• Device Sequence Number: 20467404
• Product Code: PHX
• UDI-Device Identifier: 07630040706490
• UDI-Public: 07630040706490
• 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): 10/27/2023

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: 04.01.0162
• Device Lot Number: 2246832
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian