MAUDE Adverse Event Report: TORNIER S.A.S. FLEX SHOULDER SYSTEM REVERSED TRAY TH 0 ECC 0; PROSTHESIS SHOULDER JOINT METAL

Model Number TRAY TH 0 ECC 0

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

This event is related to voluntary recall fa- wmg-2021-005 for product mix.During reassessment of the reported event after health hazard evaluation assessment was concluded the reportability decision was revised to be reported under the vigilance process with the awareness date of october-14-2021.All affected parts were recalled.The device inspection revealed the following: the received device shows that the flex shoulder system reversed tray th 0 ecc 0 labelled correspond in fact to a flex shoulder system reversed tray dia.40 th 0 ecc 1.5.A review of the device history for the reported lot did not indicate any abnormalities.Based on investigation, the root cause was attributed to a manufacturing related issue.A capa was opened and the affected parts were recalled.If any additional information is provided, the investigation will be reassessed.Device was implanted.

Event Description

In surgery on (b)(6) 2021 a box was opened for a centered reverse tray +0.The stickers all said centered reverse +0 but the implant was a 1.5mm excursion tray +0.The doctor ended up implanting the 1.5mm excursion tray.

• Brand Name: FLEX SHOULDER SYSTEM REVERSED TRAY TH 0 ECC 0
• Type of Device: PROSTHESIS SHOULDER JOINT METAL
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: laurent ray ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 12785653
• MDR Text Key: 283090101
• Report Number: 3000931034-2021-00335
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386941030
• UDI-Public: 03700386941030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/10/2021

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 Model Number: TRAY TH 0 ECC 0
• Device Catalogue Number: DWF500
• Device Lot Number: 1179AW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA- WMG-2021-005
• Patient Sequence Number: 1
• Patient Outcome(s): Other