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

Catalog Number 04.01.0162

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 18 june 2019: lot 174285: (b)(4) items manufactured and released on 12 october 2017.Expiration date: 2022-10-08.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical director: fracture of a glenoid fixation screw during rsa surgery.The screw was exchanged and no parts apparently remained in the body out of their place.No clinical consequence is to be expected.We cannot determine if the fracture was caused by an anomaly.

Event Description

The surgeon, at the time of screw fixation, found that the small glenoid polyaxial screw head broke.The surgeon commented that the screw was in axes and the correct instrument was used during surgery so he left the screw in place.The head of the screw was lost during surgery, x-rays post op do not show any screw head in the area.No delay reported during surgery.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34
• Type of Device: SHOULDER POLYAXIAL 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: 8721537
• MDR Text Key: 190350153
• Report Number: 3005180920-2019-00491
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706490
• UDI-Public: 07630040706490
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2022
• Device Catalogue Number: 04.01.0162
• Device Lot Number: 174285
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 70