Model Number 130790024 |
Device Problems
Fracture (1260); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that this was a rtsa performed on (b)(6) 2023.The surgeon used the screw in question according to the surgical technique.When the surgeon turned a screwdriver to lock the screw, the screw was not locked enough.It seemed that the screw broke when the surgeon was going to loosen the screw.The part where a screwdriver and the screw engage also broke a bit.Another screw (4.5mm×24mm) was used for the procedure and the screw was inserted successfully.The surgery was completed successfully within 30 minutes delay.There was no harm to the patient.No further information is available.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation was performed for the finished device 130790024, lot 5417314 and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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