A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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 complaint # (b)(4).Visual examination of the returned device features little in the way of markings to its surface.However, its base features a lopsided witness mark.This marking on the base of the set screw is not indicative of the set screws correctly coming into contact with and being tightened down onto the associated rod.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the set screw loosening could not be determined by the sample or information provided.A potential root cause may be accidentally setting the set screw down onto the rod incorrectly during tightening, potentially by inadvertently cross-threading the set screw upon insertion or other means, including by tightening the set screw with an over torqueing torque handle.The precise geometry of the rod in relation to the set screw and associated connector may have also influenced the screws¿ ability to lay flush to the rods.These factors could potentially allow a set screw to loosen postoperatively.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.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 complaint # (b)(4).The expedium offset ti x25 set screw was returned to the complaint handling unit (chu).The returned set screw features little in the way of markings to its surface.However, its base features lopsided witness marks.Typically, set screw witness marks are light, symmetrical marks on opposing sides of the bottom of the set screw that start as a sweeping scuff mark across its face and end in an indent.In this case, the witness marks are severe on one side and notably lighter but still deep on the other.These markings on the base of the set screw are not indicative of the set screw correctly coming into contact with and being tightened down onto the associated rod.These types of deep, lopsided impressions are possible if the torque handle exerts excessive torque on the set screw during tightening.It could also potentially lead to the set screw backing out postoperatively.A device history record review did not identify any issues that could have cause or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the set screw loosening could not be determined by the sample or information provided.A potential root cause may be the torque handle exerting excessive torque on the set screw during final tightening, resulting in deep, lopsided witness marks.This damage could potentially allow the set screw to loosen postoperatively.No issues could be identified in the manufacturing or release of this product.Therefore, this complaint will be closed with no further action required.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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