STRYKER TRAUMA KIEL NAIL HOLDING SCREW, HUMERUS T2 HUMERUS 10 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Catalog Number 18060163 |
Device Problems
Break (1069); Connection Problem (2900)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 09/28/2018 |
Event Type
Injury
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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 was reported that the nail was not connected to target device with t handle.After that, the target device (1806-0143) and holding screw (1806-0163) was locked and both devices were not able to be removed.Therefore, the target device was not used and same nail was implanted and the four screws were inserted with free hand technic.When the distal screw was inserted, the blood vessel damaged at the distal part of the nail and the vascular sutured.Cardic arrest occurred due to vascular injury, but performed cardiopulmonary resuscitation, patient's resuscitated.Patient did not have residual effect.The doctor requested that cause target device and holding screw locked and troubleshooting.
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Manufacturer Narrative
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The reported event that nail holding screw, humerus t2 humerus 10 mm was alleged of - assembling / disassembling of nail on adapter i.E seizing nhs could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by improper handling [user-customer-learning gap errors; lack of knowledge/skill].The device inspection revealed the following: we received a target device and a nail holding screw in assembled condition for evaluation.Both devices were received in a blocked mode.Disassembling of both devices was undertaken with a drill drift but to no avail.The target device received shows traces of use.The prongs at the nail adapter portion are damaged.Significant scratches / dents at the prongs are visible.Due to the deformed prongs at the nail adapter portion assembling of the three units (nail, nhs, target device) was not possible, since the thread of the nhs only rotated without reaching the nail thread.Most likely during this process parts of the shaft and the thread abraded by friction and fretting corrosion occurred.Appearance of damage at the thread and face side of the hexagon of the nail holding screw indicates that the head have been hit by a mallet which is considered off-label use.The deformed prongs of the target device also show signs of misuse.In case of intended use such damage would not have occurred.Malfunction is usually found during pre-op inspection which is required per ifu.Implying that fully function of the target device and nail holding screw was confirmed by a pre-operative check it can be concluded that the damage presented occurred during intra-operative procedure.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The ifu clearly instructs: ¿do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate!¿.
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Event Description
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It was reported that the nail was not connected to target device with t handle.After that, the target device(1806-0143) and holding screw(1806-0163) was locked and both device were not able to be removed.Therefore, the target device was not used and same nail was implanted and the four screws were inserted with free hand technic.When the distal screw was inserted, the blood vessel damaged at the distal part of the nail and the vascular sutured.Cardiac arrest occurred due to vascular injury, but performed cardiopulmonary resuscitation, patients resuscitated.Patient did not have residual effect.The doctor requested that cause target device and holding screw locked and trouble shooting.
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