MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX HUMERAL STEM; SHOULDER JOINT METAL PROSTHESIS

Model Number	STD SIZE 8A 127.5° LENGTH 90 MM
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
Different stems and all of them had a white paint like substance on them.The issue occurred in surgery, the patient was under anesthesia and there was an additional delay of 30-40 min.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS ASCEND FLEX HUMERAL STEM
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7841858
• Report Number: 3000931034-2018-00132
• Device Sequence Number: 2468988
• Product Code: KWS
• UDI-Device Identifier: 03700386945229
• UDI-Public: 03700386945229
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/30/2019
• Device Model Number: STD SIZE 8A 127.5° LENGTH 90 MM
• Device Catalogue Number: DWF607A
• Device Lot Number: 7271AO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other