Model Number DWJ326 |
Device Problems
Break (1069); Fracture (1260); Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/23/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Device disposition is unknown.
|
|
Event Description
|
It was reported that 3 peripheral screws broke off at the neck of the screw while implanting.All 3 incident have been the exact same scenario in all 3 cases the surgeon drilled the peripheral screw hole and then measured for screw depth and started to implant corresponding screw.Once the screw was about 90% implanted it would stopped turning.The surgeon in each scenario then attempted to back out the screw and it would not back out or advance any more.The surgeon then continued trying to back out the screw until it finally snapped 3-4 threads down the screw.The surgeon went about a normal technique to complete the surgery.All the debris was successfully removed from the field/patient.Products will not be returning.
|
|
Event Description
|
It was reported that 3 peripheral screws broke off at the neck of the screw while implanting.All 3 incident have been the exact same scenario in all 3 cases the surgeon drilled the peripheral screw hole and then measured for screw depth and started to implant corresponding screw.Once the screw was about 90% implanted it would stopped turning.The surgeon in each scenario then attempted to back out the screw and it would not back out or advance any more.The surgeon then continued trying to back out the screw until it finally snapped 3-4 threads down the screw.The surgeon went about a normal technique to complete the surgery.All the debris was successfully removed from the field/patient.Products will not be returning.
|
|
Manufacturer Narrative
|
Pending investigation review; 24feb2023 tm.The reported event could not be confirmed.The device was not returned.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
|
|
Search Alerts/Recalls
|