Patient identifier not available for reporting.Device is an instrument and is not implanted/explanted.Hospital contact telephone not available for reporting.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review for part #319.006 lot #9972964.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Release to warehouse date: 07-sep-2016.Supplier: (b)(4).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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Product development investigation was completed.A visual inspection, device history record review, and drawing review were performed as part of this investigation.The device was returned and it was reported that "the instrument broke off." this condition is confirmed; the instrument was returned with the needle component broken from the depth gauge slider.The needle component was observed to be slightly bent.The protection sleeve component was not returned and is missing from the instrument.The balance of the returned device is in worn condition, the handle of the depth gauge is discolored and there are scratches along the length of the instrument.Relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The 319.006 depth gauge for 2.0mm and 2.4mm screws is an instrument routinely used to measure the depth of the holes for the 2.0mm/2.4mm screws to ensure the correct screw length is used during the procedure.Although a definitive root cause could not be determined, this complaint condition is likely due to repeated usage of the instrument, leading to cumulative wear, exposure to various intra-operative forces and exposure to several sterilization (thermal) cycles throughout the service life of the device.Additionally, this condition can be possibly due to bending force(s) applied to the needle component beyond the yield limit of the material.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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