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
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3000931034-2021-00335
• Device Sequence Number: 4018450
• Product Code: KWS
• UDI-Device Identifier: 03700386941030
• UDI-Public: 03700386941030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2026
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA- WMG-2021-005
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown