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

Model Number	HEMI-PROSTHESIS ADAPTOR WITH SCREW
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/29/2017
Type of Reportable Event	Malfunction
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.A device inspection shows that the union screw didn't fit well with an aequalis reversed fracture stem, the threading is too big.A review of the device history shows that the instruction of the medical devices evolution mention that the screw (dwb923 batch # 2623ag) must be scrapped.In this case the screw (dwb923 batch # 2623ag) has not been scrapped.The root cause can be attributed to a manufacturing defect.
Event or Problem Description
During the surgical intervention of the fracture shoulder hemiprothesis system, the doctor requests a hemi prosthesis adapter ((b)(4)).It has two pieces: a screw and a plataform which fit to the humeral stem.The procedure was made follow the instructions and guides given for its correct implantation, but when the doctor tries to adjust the screw to the humeral stem it does not adjust properly, because the diameter of the screw is greater than the stem.

• Brand Name: AEQUALIS REVERSED FRACTURE
• 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: 13606771
• Report Number: 3000931034-2022-00082
• Device Sequence Number: 1930193
• Product Code: KWS
• UDI-Device Identifier: 03700386931901
• UDI-Public: 03700386931901
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K082120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: 03/25/2022
• Device Model Number: HEMI-PROSTHESIS ADAPTOR WITH SCREW
• Device Catalogue Number: DWD922
• Device Lot Number: 9159AK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2011
• 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 Age: 39 YR
• Patient Sex: Male