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

Device Problem Inaccurate Information (4051)

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

Event Date 03/25/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 281591875
• Report Number: 3000931034-2021-00339
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386941054
• UDI-Public: 03700386941054
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 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
• 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: 04/27/2021
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/10/2021
• 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