Additional narrative: patient weight is unknown.(b)(4).Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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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Subject device has been received and device history records was conducted.The report indicates that the: dhr review, part number: 351.16j , lot number: 4738173 , release to warehouse date: april 14, 2004 , manufacturing site is (b)(4) and work order completed by (b)(4).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.An investigation summary was performed.The investigation of the complaint articles has shown that:it was reported that a flexible shaft connector for use with jacobs chuck (351.16j lot 4738173 mfg 14apr2004) would not fully connect to a 5.0mm flexible shaft (352.040 lot 2087822 02feb2004); the result of which was the shaft coming loose during reaming of a femoral intramedullary canal.No fragments or surgical delay were reported and the procedure was successfully completed with alternate instruments.The returned devices were examined and the complaint condition was able to be replicated as the flexible shaft was not retained by the flexible shaft connector.A root cause related to incorrect assembly of the connector was determined after disassembling the device.This investigation summary is approved.Lot number was identified upon receipt of subject device and added.Synthes manufacturing location was discovered upon receipt of subject device.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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