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

Model Number	DWF510
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed.Based on investigation, the root cause was attributed to a manufacturing related issue.This event is related to voluntary recall fa- wmg-2021-005 for product mix.All affected parts were recalled.
Event or Problem Description
The implant inside the box doesn't match with the reference numbers on the packaging (ascend flex ref dwf510 lot 1197aw041).No adverse consequences for the patient.Another implant with the same reference have been used to complete the procedure successfully.

• Brand Name: FLEX SHOULDER SYSTEM REVERSED TRAY DIA. 40 TH 0 ECC 1.5
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• MDR Report Key: 12716246
• Report Number: 3000931034-2021-00331
• Device Sequence Number: 14646262
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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: DWF510
• Device Catalogue Number: DWF510
• Device Lot Number: 1197AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: WMG-2021-005
• Patient Sequence Number: 1