WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAND PIECE FOR BATTERY POWERED DRIVER; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH
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Model Number 05.000.008 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Additional product codes: hxx and gxl.Initial reporter is a synthes sales representative.A service history review (shr) was performed on the serviceable device and it was found that the device was manufactured on january 28, 2011.A manufacturing related potential cause was not suspected.Service and repair history: the previous service event has been reviewed.The customer called in a service request for this item on (b)(6) 2020 for unknown issue.The item was previously returned for service on june 06, 2011 due to motor failure.The previous service condition of motor failure is not relevant to the current complained issue of unknown issue.The service history review is unconfirmed.Service and repair evaluation was completed: the customer reported that the hand piece for battery powered driver was found to have an unknown allegation.The repair technician reported the device did not run in fast forward and forward, and there are cracks in the contact plate.Also, there was debris on the column, wires were burnt, and the bearings were grinding.Damaged component is the reason for repair.The cause of the issue is damaged component.The following parts were replaced: circuit board, motor, membrane switch/flex circuit, and all applicable components.The item was repaired per the inspection sheet, passed synthes final 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 will be 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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Event Description
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It was reported that during testing of the device on an unknown date, the hand piece for battery powered driver was found to have an unknown allegation.There were no patient and surgical involvement.During the investigation of the returned device by the manufacturer, it was noted, the device did not run in fast forward and forward, and there are cracks in the contact plate.Also, there was debris on the column, wires were burnt, and the bearings were grinding.This report is for a hand piece for battery powered driver.This is report 1 of 1 for (b)(4).
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