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

Model Number HEMI-PROSTHESIS ADAPTOR WITH SCREW

Device Problem Defective Component (2292)

Patient Problem Failure of Implant (1924)

Event Date 09/29/2017

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 289318965
• Report Number: 3000931034-2022-00082
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386931901
• UDI-Public: 03700386931901
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K082120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Male