Additional narrative: event date: unknown.Device is an instrument and is not implanted/explanted.Service history review: lot 2495372: no service history review can be performed as this is a lot controlled item.The service history evaluation is unconfirmed.A service and repair evaluation was completed: the customer reported the knurled cap and tip were missing.The repair technician reported the tip had wear marks.Tip broken is the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit.The evaluation was confirmed.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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An investigation review was performed.The investigation of the complaint articles has shown that: one of the following device(s) was received: depth gauge (part # 319.090 | lot # 2495372), depth gauge (part # 319.04 | lot # 3252561), the returned devices show signs of regular usage, with various scratches and marks.The devices have no functional damage but are missing the headpiece and knurled cap.The missing components were most likely lost in sterile processing while the device was disassembled.This complaint is confirmed, but is due to a handling error rather than the design of the instrument.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.This investigation is approved.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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