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

Model Number	04.01.0162
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 1 december 2022: lot #: 2215682: (b)(4) items manufactured and released on 27-jul-2022.Expiration date: 2027-jul-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Visual inspection: the pictures show that the drill bit broke at the beginning of the fluted portion and that the four broken prongs of the screw and the inner locking screws were removed properly.No deviation from the surgical technique is noticed.The event may be related to the high quality of the patient's bone as two separate independent cases happened during the same surgery.We did not receive the screwdriver involved in the complaint and neither its lot.
Event or Problem Description
During primary surgery, during glenoid preparation, the drill bit for polyaxial screw broke and the broken piece was left in the patient bone.Then, when inserting the anterior polyaxial locking screw l34, one of the prong broke.Placement of the screws was done using screwdriver.In the attempt of removing the screw with a competitor removal device, the tip of removal device broke inside the screw, therefore the screw had to be left in the patient.The part of the screw protruding from the baseplate was cut off with pliers.The surgery was completed successfully with 30-minutes delay.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34
• Common Device Name: SHOULDER POLYAXIAL SCREWS
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15969314
• Report Number: 3005180920-2022-00914
• Device Sequence Number: 5229321
• Product Code: PHX
• UDI-Device Identifier: 07630040706490
• UDI-Public: 07630040706490
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 12/13/2022

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: 04.01.0162
• Device Catalogue Number: 04.01.0162
• Device Lot Number: 2215682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: White