TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number DWD181 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a surgical procedure, the surgeon requested the lateralized glenoid sphere +4mm the medical device had the fixation screw blocked, preventing its correct implantation in the 25mm screwed base plate.The surgeon tried to loosen the screw several times without success.Surgeon decided to request a new glenosphere to implant it to the patient.The surgeon decided to insert the eccentric glenoid sphere +2mm.The surgery ends without serious events and the patient does not present any problem or serious repercussion.Due to this situation, the surgeon did not allow the disortho surgical assistant to charge the centered glenoid sphere hospital.
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
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Manufacturer Narrative
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Please note the corrections to d9/h3 and the h6 component code: the reported event could be confirmed (jammed safety screw in the glenoid sphere before impacting) since the device was returned and was found to be in condition stated in the event description.The device inspection revealed the following: -the visual inspection confirmed that the safety screw was jammed in the glenoid sphere.-after loosening the safety screw, the functionality of the sphere was checked, and it could correctly impact and tighten into the baseplate-gauge without issue to report.The issue described in the reported event was unable to be reproduced.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that during a surgical procedure, the surgeon requested the lateralized glenoid sphere +4mm the medical device had the fixation screw blocked, preventing its correct implantation in the 25mm screwed base plate.The surgeon tried to loosen the screw several times without success.Surgeon decided to request a new glenosphere to implant it to the patient.The surgeon decided to insert the eccentric glenoid sphere +2mm.The surgery ends without serious events and the patient does not present any problem or serious repercussion.Due to this situation, the surgeon did not allow the disortho surgical assistant to charge the centered glenoid sphere hospital.
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