MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED ADAPTOR METAPHYSIS UNION SCREW; SHOULDER JOINT METAL PROSTHESIS

Catalog Number	DWD054
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/23/2018
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
Torque was applied to the nut part when attaching the nut of the conversion adapter, so the humerus broke the bone trunk fracture.Since it was an operation of the revision, the surgeon prepared a plate and a cable, and performed osteosynthesis with this implant.About 2 hours of operative lengthening.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED ADAPTOR METAPHYSIS UNION SCREW
• 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: 7797148
• Report Number: 3000931034-2018-00096
• Device Sequence Number: 2076870
• Product Code: KWS
• UDI-Device Identifier: 03700386931666
• UDI-Public: 03700386931666
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081059
• 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): 07/24/2018

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: No Information
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: DWD054
• Device Lot Number: 6981AN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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: 73 YR