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: d2: additional procodes: hxx, hwe.E3: initial reporter is a synthes employee.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part # 05.000.008.Synthes lot # 006597.Supplier lot # 006597.Release to warehouse date: 18 may 2017.Supplier: (b)(4).No ncrs were generated during production.Service & repair evaluation the customer reported that the 05.000.008 hand piece for battery powered is broken.The repair technician reported that the device made whining sound, wires were discolored, brown residue on the motor and the barriers.Preventive maintenance is the reason for repair.The cause of the issue is unknown.The item was repaired per procedure, passed inspection, and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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 (b)(6) 2023, the battery powered driver in question was used during a case to drill a resorbable tap into bone, however the driver would not reverse.After the case the driver was tested by the sales consultant, and it demonstrated less power than other drivers of the same type.There was no reported adverse patient impact.No further information is available.This report is for a hand piece for battery powered driver.This is report 1 of 1 for (b)(4).
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