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

Device Problem Inaccurate Information (4051)

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

Event Date 03/18/2021

Event Type  malfunction  

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).

Event Description

When opening the package we identified the package as being a aa flex humeral tray (dwf510).When opening the implant i identified the implant being a dwf500.Luckily we had an other implant set on site so we could use a dwf510 from that kit.It delayed the surgery of 10 minutes.

• Brand Name: FLEX SHOULDER SYSTEM REVERSED
• Type of Device: 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: 12779141
• MDR Text Key: 280538499
• Report Number: 3000931034-2021-00051
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386941054
• UDI-Public: 03700386941054
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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: 05/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA- WMG-2021-005
• Patient Sequence Number: 1
• Patient Outcome(s): Other