Product complaint #: (b)(4).Additional product code: hwc jds.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.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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It was reported that on an unknown date, during a procedure, the orthopedic plate and screws back out or were broken/failed.The patient was revived with another plate.The initial orif occurred on (b)(6) 2021.It was discovered on (b)(6) 2021, that the hardware had detached from the patient's femur.No broken fragments were left in the patient.There was a surgical delay.The surgery was successfully completed.The patient was recovering successfully.This complaint involves ten (10) devices.This report is for (1) 5.0 ti locking screw self-drilling 75.This report is 5 of 8 for (b)(4).
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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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: the complaint condition was not confirmed for the 5.0 ti locking screw self-drilling 75 (p/n: 422.396 & lot #: 2548132).During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: as per jde, the manufactured date for device is 07-dec-2009.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(4) no manufacturing record evaluation is required.Device was used for treatment, not diagnosis.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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