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

Model Number LOCKING SCREW 4.5X38MM

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

On november 10st, 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.The threading portion of the screw under the head is missing.Left in baseplate.Surgery was completed (screw left in baseplate).The 3 other screws guarantee the stability of the implant.A review of the device history for the reported lot did not indicate any abnormalities.Screw rupture under head may be related to several reasons: in case of a motorized screwdriver use which may generate an excessive torque.In screwing on the last threads of the screw with a relatively dense bone in link with the screw length (38mm of length in this case).In case of a bad hexagonal gripping/fitting between the screw and the screwdriver.According to the data available and the analysis conducted on the device, the root cause could not be clearly determined.

Event Description

Head of locking screw sheared off.Surgery was completed.Screw was left in baseplate.

• Brand Name: AEQUALIS REVERSED
• Type of Device: PROSTHESIS SHOULDER METAL
• Manufacturer (Section D): TORNIER S.A.S; 161 rue lavoisier; montbonnot saint martin, ; FR
• Manufacturer Contact: laurent ray ; 161 rue lavoisier; montbonnot saint martin ; FR
• MDR Report Key: 13606985
• MDR Text Key: 286659401
• Report Number: 3000931034-2022-00060
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386916687
• UDI-Public: 03700386916687
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2016

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 Model Number: LOCKING SCREW 4.5X38MM
• Device Catalogue Number: DWD038
• Device Lot Number: 0438AQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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: 67 YR
• Patient Sex: Female