Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Release to warehouse date: march 19, 2001.Manufacture site: synthes (b)(4).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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The returned instrument was evaluated at customer quality and the complaint was able to be confirmed, however, the device was not missing the reported component that has the depth markers (slider).The needle had broken off from the slider component.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.There is a protection sleeve (not returned) to protect the needle during transport; and the outer body adds additional protection to the needle attachment point during storage.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Replication of the complaint is not applicable as the complaint conditions were visually confirmed.This complaint is confirmed.The 319.006 depth gauge is part of at least 14 technique guides, including the 2.4 mm variable angle lcp distal radius system and is 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.The information is provided per the 2.4 mm variable angle lcp distal radius system technique guide dsus/trm/0515/0599.Relevant product drawings were reviewed: no drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The thickness of the needle (1.25 mm) is driven by the fact that the needle must fit into a drilled hole of 1.5 mm, and the length (80 mm) is determined so the slider can measure screws up to 40 mm.The material of the needle probe component (part # 319.006.03) is extra hard 316ss, which is an appropriate material for an instrument component of this type.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.There is a protection sleeve (not returned) to protect the needle during transport; and the outer body adds additional protection to the needle attachment point during storage.No new, unique, or different patient harms were identified as a result of this investigation.The design is determined to be adequate for its intended use when used and maintained as recommended.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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