MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED TRIAL STEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	METAPHYSIS 036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
Patient underwent reverse shoulder replacement.A trial prosthesis was assembled, implanted and removed.When the permanent prosthesis was subsequently being assembled, the trial metaphyseal component was inadvertently attached to the implant holder and implanted in the patient.The flawed implant was shortly thereafter through review of a fluoroscopy film.In order to complete the procedure, it was necessary to remove the flawed prosthesis which was different difficult since the cement had curred.In the end the surgeon elected to perform an osteotomy of the proximal humerus.The maneuvering of the soft bone resulted in a fracture of the distal humerus.The surgeon ultimately was able to insert another prosthesis and the patient was discharged 3 days later.Problem identified: trial modular components were not easily distinguishable from the permanent modular components which was a direct cause of the user error.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.(please refer to medwatch report sent by hospital on 10-oct-2016 for patient (b)(6)).As far as conclusion code is concerned, please note that the surgeon used a trial during the surgery.

• Brand Name: AEQUALIS REVERSED TRIAL STEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7153962
• Report Number: 3000931034-2016-00208
• Device Sequence Number: 14153057
• Product Code: LXH
• UDI-Device Identifier: 03700386969133
• UDI-Public: 03700386969133
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2016

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 Model Number: METAPHYSIS 036
• Device Catalogue Number: MWB175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/20/2016
• Supplement Date Received by Manufacturer: 10/20/2016
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 12/29/2017
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 76