MAUDE Adverse Event Report: TORNIER S.A.S AEQUALIS REVERSED II; PROSTHESIS SHOULDER METAL

Model Number	THREADED POST BASEPLATE Ø25 L30
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The olive broke from baseplate.
Additional Manufacturer Narrative
On (b)(6) 2020 stryker trauma and extremities acquired tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.Olive is disassembled from the baseplate.No particular visual trace to report.A review of the device history for the reported lot did not indicate any abnormalities.Overstress on the olive due to the application of an excessive angle done with a drill guide & a drill, can lead to the threaded ring disassembly.The threaded ring housing is adapted to receive a compression screw.The compression screw assembly does not affect the prosthesis functionality.Issue probably due to an inappropriate device use.

• Brand Name: AEQUALIS REVERSED II
• Common Device Name: PROSTHESIS SHOULDER METAL
• Manufacturer (Section D): TORNIER S.A.S; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: laurent ray ; 161 rue lavoisier; montbonnot saint martin 38330 ; FR 38330
• MDR Report Key: 13606700
• Report Number: 3000931034-2022-00058
• Device Sequence Number: 16633327
• Product Code: KWS
• UDI-Device Identifier: 03700386952661
• UDI-Public: 03700386952661
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2016

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 Expiration Date: 06/30/2020
• Device Model Number: THREADED POST BASEPLATE Ø25 L30
• Device Catalogue Number: DWE730
• Device Lot Number: 1315AQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2016
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2015
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown