Visual inspection by cq of the returned depth gauge revealed the depth gauge¿s needle had broken off; the break occurred where the needle threads into the slider: the needle broke flush with the slider.The broken needle and the protection sleeve were not returned.Dimensional inspection of needle component could not be conducted due to the post manufacturing deformation at the break, the location of the break, and the distal portion of the broken needle was not received.The complaint is confirmed.The exact cause of the complaint condition cannot be determined as the handling and use of the device are unknown.However, the condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part # 319.006, synthes lot # h521671, supplier lot # h521671, release to warehouse date: 04 dec 2018, supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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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It was reported that on an (b)(6) 2019, the depth gauge got broken during washing at the sterile processing department (spd).It was mentioned that after the item was sent through the washer, during routine checks before sterilizing items, it was noticed that the metal tip at the base of the inside gauge was loose.When the tip of depth gauge was touched, it fell off where it attaches.There were no patient and surgical involvement.This complaint involves one (1) device.
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