MAUDE Adverse Event Report: TORNIER S.A.S. FLEX SHOULDER SYSTEM REVERSED TRAY DIA. 40 TH 0 ECC 1.5; PROSTHESIS SHOULDER JOINT METAL

Model Number	TRAY DIA. 40 TH 0 ECC 1.5
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device inspection revealed the following: the received device shows that the flex shoulder system reversed tray labelled dia.40 th 0 ecc 1.5 correspond in fact to a flex shoulder system reversed tray th 0 ecc 0.Due to the nature of the complaint, a functional inspection was not considered necessary.Due to the nature of the complaint, a dimensional inspection was not considered necessary.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.
Event or Problem Description
The surgeon asked the nurse to unpack a reversed tray ecc +1.5 (dwf510).However in the packaging was present a reversed tray ecc 0 (dwf500).A new implant have been opened with the same reference but with a different lot.No major prolongation of the surgery.

• Brand Name: FLEX SHOULDER SYSTEM REVERSED TRAY DIA. 40 TH 0 ECC 1.5
• 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: 12790736
• Report Number: 3000931034-2021-00339
• Device Sequence Number: 4982623
• Product Code: KWS
• UDI-Device Identifier: 03700386941054
• UDI-Public: 03700386941054
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• 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: 02/25/2026
• Device Model Number: TRAY DIA. 40 TH 0 ECC 1.5
• Device Catalogue Number: DWF510
• Device Lot Number: 1197AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• 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): Yes
• Date Device Manufactured: 02/25/2021
• 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