Model Number DWD180 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of the investigation, additional information will be provided in a supplemental report.
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Event Description
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It was reported that for three glenoids the central screw was blocked and could not be used in surgery.The surgeon placed an implant of another reference (eccentric glenoid because the stock of this reference was exhausted).The operation was completed successfully with an increase in operating time of 30 minutes.
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Manufacturer Narrative
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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 for three glenoids the central screw was blocked and could not be used in surgery.The surgeon placed an implant of another reference (eccentric glenoid because the stock of this reference was exhausted).The operation was completed successfully with an increase in operating time of 30 minutes.
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Manufacturer Narrative
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Please note the following correction: the establishment fda registration number was corrected from 0001649390 to 3000931034.D3 (manufacturer entity) and g1 (manufacturing site).
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Event Description
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It was reported that for three glenoids the central screw was blocked and could not be used in surgery.The surgeon placed an implant of another reference (eccentric glenoid because the stock of this reference was exhausted).The operation was completed successfully with an increase in operating time of 30 minutes.
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Search Alerts/Recalls
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