STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 13200100 |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/14/2016 |
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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It is reported by the hospital, that during drilling through the target device the screw holes of the nail can't be hit.As per rep, it was proxmial missdrilling, procedure was successfully completed; not reported how.No adverse consequences.No prolongation of surgery.
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Manufacturer Narrative
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The target device returned is regarded as primary product.The speedlock sleeve returned is regarded as associated product.Appearance of item and inspection records identified the target device returned being of new design version.Deviations in the inspection documents were not found.A check of the function on 100% of the devices (sub-supplier) and additional in-house spot check of the lot in question revealed function was given in full on the devices at the stage of delivery.The item returned was documented as faultless prior to distribution and as it had been in use for a longer time (approximately 4 years) we pre-suppose that this target device had fulfilled its tasks in former surgeries as intended.The returned target device passed the pre-operative function test as intended.Neither a proximal mistargeting nor a distal mistargeting could be confirmed.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check it was concluded that the event(s) were mainly based in the intra-operative procedure.Reasons for misaligned drilling are various.Potential miss-targeting can also be caused but is not limited by e.G.- loosening of the nail holding bolt during insertion of the nail - repeated tightening of the nail holding screw prior to distal targeting / drilling is recommended - not realized unintended loosening of the attachment knob (will lead to release of the drill sleeve) - no use of drill with centre tip / unfavourable bone contour - drilling without drill guiding sleeve - using blunt or damaged drill - high forces applied to the target device during drilling eventually leading to unintended distortion in the system of drill, sleeve, target device and nail referring to received information it is suggested that potential deviation in proximal targeting accuracy should have been detected during required functional check prior to use.No information was given which kind of nail had been used.Further, the kind of preparing the intramedullary canal may be essential for inserting the nail without deflection.Depending on the bone curvature, this may contribute to sufficient drilling.Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure.The found deep impacts in the peek material are clearly identified due to hammering onto the device which is regarded as user related.The brochure instructions for cleaning, sterilization, inspection and maintenance (l240020009) shows several examples of damages and recommends removing of such damaged products.
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Event Description
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It is reported by the hospital, that during drilling through the target device the screw holes of the nail can't be hit.As per rep, it was proxmial missdrilling, procedure was successfully completed; not reported how.No adverse consequences.No prolongation of surgery.
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