MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX SHOULDER SYSTEM; AEQUALIS ASCEND FLEX REVERSED INSERT

Model Number	DIA.36 +6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
It was reported that a patient underwent a post-operative instability-dislocation (anterior).Problem resolved without sequelae by closed reduction.(b)(6).
Additional Manufacturer Narrative
Supplemental # 01 : additional information about serial and lot numbers.This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS ASCEND FLEX SHOULDER SYSTEM
• Common Device Name: AEQUALIS ASCEND FLEX REVERSED INSERT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5853181
• Report Number: 3000931034-2016-00102
• Device Sequence Number: 16246872
• Product Code: KWS
• UDI-Device Identifier: 03700386940514
• UDI-Public: 03700386940514
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: DIA.36 +6
• Device Catalogue Number: DWF361C
• Device Lot Number: 3196AQ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2016
• Supplement Date Received by Manufacturer: 07/13/2016
• Initial Report FDA Received Date: 08/08/2016
• Supplement Report FDA Received Date: 01/09/2018
• 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
• Patient Age: 51 YR
• Patient Weight: 102