MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L38

Catalog Number 04.01.0163

Device Problem Difficult to Remove (1528)

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

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 24-may-2018: lot 174286: (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 medical affairs director on 18-may-2018: intraoperative partial fracture of the locking screw meant to hold the glenoid component.The residual implant can perform correctly and fully the stabilization task, with the exception of the angular stability, which is an additional feature introduced by a proprietary device.There is no indication therefore that the clinical outcome of the rsa should be jeopardized by this event.The reasons that led to the intraoperative fracture cannot be established through the clinical investigation.Preliminary investigation performed by r&d product manager on 24-may-2018: the issue may have occurred due to the bone being very sclerotic, resulting in a particularly high resistance provided during the insertion phase, or the pilot hole being too shallow.Based on the given information, it is not possible to state which of the above mentioned scenarios is more likely to have happened.

Event Description

During screwing, the head of the screw opened.After this it was impossible to unscrew it out.Surgeon took out the inner small screw and broke the 4 flaps with a clamp, so the screw was deep enough for no impingement.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L38
• Type of Device: GLENOID POLYAXIAL LOCKING 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7544750
• MDR Text Key: 109506483
• Report Number: 3005180920-2018-00365
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706506
• UDI-Public: 07630040706506
• 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: Other
• Type of Report: Initial
• Report Date: 05/25/2018

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: 04.01.0163
• Device Lot Number: 174286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/25/2018
• 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: 67 YR
• Patient Weight: 95