The sales representative reported on behalf of the customer that the pro7200se was being used during a mandibulectomy hemi with reconstruction on (b)(6) 2020 when a blade disengaged from the handpiece.A second handpiece was used, and the same failure occurred with the accessory blade.A third handpiece was used; however, the user felt that this handpiece did not have the same failure effect as the previous two handpieces.Due to the previous failed devices the user chose to change technique and use a chisel/osteotome to complete the procedure.This resulted in the patient sustaining a pathological fracture due to the chiseling.The user stated that this would cause the patient extended hospitalization.The current status of the patient is unknown.This report is being raised on the basis of injury due to the fracture sustained by the patient being an indirect result of the handpiece failure.
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The sales representative reported on behalf of the customer that the 000602002200 was being used during a mandibulectomy hemi with reconstruction on 15jul20 when a blade disengaged from the handpiece.A second handpiece was used, and the same failure occurred with the accessory blade.A third handpiece was used; however, the user felt that this handpiece did not have the same failure effect as the previous two handpieces.Due to the previous failed devices the user chose to change technique and use a chisel/osteotome to complete the procedure.This resulted in the patient sustaining a pathological fracture due to the chiseling.The user stated that this would cause the patient extended hospitalization.The current status of the patient is unknown.This report is being raised on the basis of injury due to the fracture sustained by the patient being an indirect result of the handpiece failure.
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Correction: previously the reporter reported the wrong catalog number device that was used in this event.All information for the incorrect device, pro7200se, has been changed to the correct device, 00602102200.All corrections below are in regards to this change: b5 - updated the catalog number d1/d2 - updated with information of the correct catalog number d4 - updated with catalog and serial number g4 - updated with the correct 510k for the device number change.Manufacturer narrative: an evaluation of the returned device found that the safe slide is worn, and the blade did come loose while cutting through a 2x4 of wood.The unit however met ground bond, speed and all other tests.The most likely cause of this failure is lack of preventive maintenance, the device is supposed to be returned every 12-month for servicing.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history of this device was reviewed and found no data.At the time of this report the device is 131 months of age.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding 5 devices, for this device family and failure mode.During this same time frame 474,671 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.00001.Per the instructions for use, the user is advised the following: maintenance schedule: the micropower handpieces and attachments shall be returned every 12 months for servicing.This issue will continue to be monitored through the complaint system to assure patient safety.
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