Product complaint # (b)(4).The device was received at service center and evaluated.The defect(s) reported by the customer has/have been verified and repaired using the measures listed in the "proof of repair".Resistance value out of specs: handcontrol set replaced; keyboard pcb corroded, handcontrol set replaced; defective drill mounting mechanism 1.0 has been replaced by 1.25; "micro": preventive replacement of o-rings performed.Acc.To service manual: unit cleaned, functional test performed, hipot test completed, electrical safety test acc.Completed, functional test acc.To test procedure completed, safety test checklist enclosed.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.As per the service report the locking ring doesn't close & on/off button doesn't respond,hence handcontrol set replaced.Therefore it is the root cause for reported failure.At this point, 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate (b)(4).
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