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

Device Problem Inaccurate Information (4051)

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

Event Date 11/25/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 283769304
• Report Number: 3000931034-2021-00354
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386941030
• UDI-Public: 03700386941030
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other