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.Additional narrative: 510k: this report is for an unknown plates: dhs/dcs/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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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Device report from synthes reports an event in japan as follows: it was reported that this was a bha on an unknown date.In the surgery, the surgeon attempted to remove a stainless-steel dhs plate in question that was probably inserted more than 30 years ago.But, callus had formed and it took time to remove the implant.The firmly fixed lag screw could not be removed by the extraction instrument.Therefore, the lag screw was removed during the osteotomy of the bha.The removal procedure was completed successfully within 30 minutes delay.The cause of bha was not reported.This report involves one (1) unknown plates: dhs/dcs.This is report 1 of 2 for (b)(4).
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