(b)(6).The exact date of device breakage and non-union is unknown.This report is for one (1) unknown broken locking screw.At this time, the exact part number is unknown, but is likely one of the following three: 04.005.420: 4.0mm ti locking screw w/t25 stardrive 30mm for im nails ¿ hsb: rod, fixation, intramedullary ¿ k103002, 04.005.424: 4.0mm ti locking screw w/t25 stardrive 34mm for im nails ¿ hsb: rod, fixation, intramedullary ¿ k103002, 04.005.430: 4.0mm ti locking screw w/t25 stardrive 40mm for im nails ¿ hsb: rod, fixation, intramedullary ¿ k103002.Without verification of the exact part number and its associated lot, the udi is not available.Per facility, the complainant part is not expected to be returned for manufacturing review/investigation.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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It was reported that a hardware removal and revision procedure was performed on (b)(6) 2016.The patient presented with non-union; it was then confirmed that one (1) of the implanted 4.0mm titanium (ti) locking screws had broken distally.During the revision, a ti adolescent lateral femoral nail and three (3) screws were removed.A portion of the broken screw remained in situ.The patient was then revised with a proximal femur hook plate.The procedure was completed successfully with a post-operative patient outcome of stable.Concomitant device(s) reported: femoral nail (part: 04.031.934s / lot: unknown / quantity: 1), recon screw (part: 04.031.025 or 04.031.028 / lot: unknown / quantity: 1), locking screws (partial part: 04.005.4xx / lot: unknown / quantity: 2).This report is for one (1) unknown broken ti locking screw.This report is 1 of 1 for com-(b)(4).
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