MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV TRAY 0TH 1.5MM OFFSET; SHOULDER JOINT METAL PROSTHESIS

Model Number	DWF500
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.This event is related to voluntary recall fa- wmg-2021-005 for product mix.Device not yet received.
Event or Problem Description
Today i had a wrong implant in a package.The package indicated dwf510 and it seemed to have a dwf500 in the package.

• Brand Name: TORNIER FLEX SHOULDER SYS REV TRAY 0TH 1.5MM OFFSET
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• 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: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 13048760
• Report Number: 3000931034-2021-00354
• Device Sequence Number: 3912840
• Product Code: KWS
• UDI-Device Identifier: 03700386941030
• UDI-Public: 03700386941030
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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 Model Number: DWF500
• Device Catalogue Number: DWF510
• Device Lot Number: 1197AW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown