MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30; SHOULDER GLENOID POLYAXIAL LOCKING SCREW

Catalog Number 04.01.0161

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 17 june 2019: lot 182475: (b)(4) items manufactured and released on 04 september 2018.Expiration date: 2023-08-22.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.Preliminary analysis performed by r&d shoulder manager: the inner screw used to provide angular stability to the polyaxial glenoid screw is confirmed to be broken at the base of the conical section.The x-ray does not show sign of incorrect positioning of the screw.At the moment, no assumption can be made about the possible root cause.Other instrument involved in the complaint: shoulder general 04.01.10.0269 modular 2nm tl screwdriver - small ao lot.1853566.Batch review performed on 17 june 2019: lot 1853566: (b)(4) items manufactured and released on 29 november 2018.No anomalies found related to the problem.To date, this is the first similar event reported on items of the same lot.Visual inspection performed by r&d project manager: the subject instrument was internally tested, simulating the dedicated surgical steps.A 30 pcf sawbones blocks was used as substitute of the glenoid bone in order to represent the worst case condition (i.E.A sclerotic glenoid bone).A glenoid polyaxial locking screw was inserted in a previous prepared hole in one seat of the baseplate implant and screwed to fully sit the head in the baseplate hole with the glenoid polyaxial screwdriver.Afterwards, the modular 2nm tl screwdriver - small ao under complaint was assembled with the modular screwdriver - t10 tip and slid inside the glenoid polyaxial screwdriver.The inner screw of the glenoid polyaxial locking screw was tightened until the torque limiting screwdriver slipped, as prescribed in the surgical technique.The manoeuvre was repeated three times and the torque limiting screwdriver slipping always was felt.Moreover, the torque limiting feature of the instrument under complaint was controlled and the test, simulating the surgical step for 25 times, was always passed: the obtained values range from 1.970nm to 2.025nm.The results show that the item is conformed, the torque values are inside the conformity range, so that the problem described in the complaint is to attribute at the surgical procedure only.Clinical evaluation performed by medical affairs manager: during insertion and fixation of a angled screw, the head of the locking screw broke.According to the report broken pieces were removed and are not visible in the xray provided.No significant alteration of the screw position is visible nor expected in the future.The reason of this event cannot be determined.

Event Description

During the reverse shoulder case, dr (b)(6) drilled into the glenoid.He then put a 30mm screw into the hole.He admits it was slightly angled but it was still an angle that the drill guide allowed him to drill.As he applied the torque screw driver to the screw (the small one) to lock it in, the head of the screw (the small one) snapped off inside the patient.The torque screw driver hadn't even clicked yet so he wasn't using any excess force in any way.He was able to recover the piece of the screw but the rest of the screw was then left in situ as it wasn't interfering with the implant.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30
• Type of Device: SHOULDER GLENOID POLYAXIAL LOCKING 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: 8712080
• MDR Text Key: 193636380
• Report Number: 3005180920-2019-00480
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706483
• UDI-Public: 07630040706483
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2023
• Device Catalogue Number: 04.01.0161
• Device Lot Number: 182475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2019
• 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: 76 YR
• Patient Weight: 75