MAUDE Adverse Event Report: TORNIER S.A.S. FLEX SHOULDER SYSTEM REVERSED; PROSTHESIS SHOULDER 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	03/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Discrepancy between the implant label noted (eccentered) on the packaging and the implant inside (centered).Opening of another implant.No delay.
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.Investigation was conducted and confirmed that two specific lots of flex reversed tray have been swapped and contain the incorrect product in the package : aequalis ascend flex reversed tray (+)0 thickness, 1.5mm offset, reference dwf510, lot 1197aw and aequalis ascend flex reversed tray (+)0 thickness, 0.0mm offset, reference dwf500, lot 1179aw.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.The affected parts were recalled.The root cause is attributed to a manufacturing defect (human error during a packaging step).

• Brand Name: FLEX SHOULDER SYSTEM REVERSED
• Common Device Name: PROSTHESIS SHOULDER 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
• MDR Report Key: 12779125
• Report Number: 3000931034-2021-00054
• Device Sequence Number: 11664701
• 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
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/09/2021
• 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