MAUDE Adverse Event Report: FLEX SHOULDER SYSTEM REVERSED TRAY DIA. 40 TH 0 ECC 1.5; PROSTHESIS SHOULDER JOINT METAL

Model Number	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	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Absence of a dial to reproduce the test in its final version: impossible to identify the positioning of the platform on the rod, and the positioning of the insert on the platform implant not conform with the needed one.Apparently the problem has already been reported because the platform would in fact be a centered 0 of ref dwf 500 in the packaging of a dwf 510.No substitute device since only one unit in the deposit ; approximate and random positioning at the end.Prolongation of fifteen minutes of the surgery and many hesitations during the procedure.
Additional Manufacturer Narrative
The reported event was confirmed based on a visual inspection done on a part of the same lot code.Based on investigation, the root cause was attributed to a manufacturing related issue.A capa was opened and the affected parts were recalled.
Event or Problem Description
Absence of a dial to reproduce the test in its final version: impossible to identify the positioning of the platform on the rod, and the positioning of the insert on the platform implant not conform with the needed one.Apparently the problem has already been reported because the platform would in fact be a centered 0 of ref dwf 500 in the packaging of a dwf 510.No substitute device since only one unit in the deposit ; approximate and random positioning at the end.Prolongation of fifteen minutes of the surgery and many hesitations during the procedure.

• Brand Name: FLEX SHOULDER SYSTEM REVERSED TRAY DIA. 40 TH 0 ECC 1.5
• Common Device Name: PROSTHESIS SHOULDER JOINT METAL
• MDR Report Key: 11916524
• Report Number: 3000931034-2021-00260
• Device Sequence Number: 17247653
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: DIA. 40 TH 0 ECC 1.5
• Device Catalogue Number: DWF510
• Device Lot Number: 1197AW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other