The reason for this instrument failure was reported as disassociation.The possible time in service for baseplate is 5.2 years from manufactured date.Initial or prolonged hospitalization was required.The healthcare professional indicated this event occurred during surgery, near the patient.The device was not returned to manufacturer and made available at djo surgical for examination.A review of 800-05-025 device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the production of this instrument.Complaint database review showed 85 previous complaints, there were indications that this instrument has a design or material deficiency.Those are 85 broke/cracked/damaged.The root cause of this complaint is impactor tip disassociated from the metal base.There are no indications that this instrument has a material nonconformance.This issue does not create patient risk; therefore, no containment of inventory is required.The event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument was not returned, it was lost / discarded on site.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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