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.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.H10 additional narrative: correction: d1, d4: the brand name and catalog have been updated accordingly to reflect the correct information.Therefore, udi: (b)(4).Additional information: h4: the device manufacture date was reported as unknown on the initial report and has been updated accordingly.Device evaluation: investigation summary = > according to the information provided, it was reported that 8 ultra aggressive blades released metallic debris in the joint during the procedure.The complaint devices were received and evaluated.Visual observations confirm that 7 blades were received new in the original package and sealed; the sterility was not compromised.The blade received used, was evaluated and no anomalies were found.Further investigation under magnification revealed no anomalies, some marks of use were observed.No other anomalies were identified.Therefore the complaint was not confirmed.A possible root cause for the reported failure can be attributed to interaction between two metal devices that could precludes the devices to function as intended, however this cannot be conclusive determined.As there is no indication that a potential cause is associated to manufacturing, a manufacturing record evaluation is not required.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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