STRYKER TRAUMA KIEL EXTRACTION HOOK, SMALL IMPLANT EXTRACTION SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Catalog Number 18066160 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Fall (1848); Failure of Implant (1924)
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Event Date 12/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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The patient underwent hansson pin lock surgery on (b)(6) 2017, and then she fell down and subtrochanteric fracture occurred.Therefore, revision surgery was performed using t2 reconstruction nail on (b)(6) 2017.In (b)(6) 2017, the t2 reconstruction nail was broken due to pseudoarticulation.On (b)(6) 2017, revision surgery was performed.During the surgery, extraction of the distal nail was attempted using extraction hook small and slide hummer, but the tip hook was broke inside the bone.The distal nail was removed with ball-tipped and smooth-tipped guidewire, and the tip hook was retrieved using suction tube and teflon tube.
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Manufacturer Narrative
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The reported event that extraction hook, small implant extraction set was alleged of issue (instruments - broken, deformed, worn or scratched) could be confirmed, since the device returned for evaluation matches with alleged failure mode.During the visual inspection it was observed that the breakage surface indicates that the tip broke due to a bending overload.The material of the extraction hook is hardened, so that it is harder than the nail which is to be extracted using the hook.Hardened materials are brittle and rather break than bend.Therefore, it is not allowed to bend the extraction hook.The case is attributed to an insufficient handling by the user.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.
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Event Description
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The patient underwent hansson pin lock surgery on (b)(6) 2017, and then she fell down and subtrochanteric fracture occurred.Therefore, revision surgery was performed using t2 reconstruction nail on (b)(6) 2017.In (b)(6) 2017, the t2 reconstruction nail was broken due to pseudoarticulation.On (b)(6) 2017, revision surgery was performed.During the surgery, extraction of the distal nail was attempted using extraction hook small and slide hummer, but the tip hook was broke inside the bone.The distal nail was removed with ball-tipped and smooth-tipped guidewire, and the tip hook was retrieved using suction tube and teflon tube.
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