ARTHREX, INC. DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET |
Device Problems
Break (1069); Loose or Intermittent Connection (1371)
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Patient Problem
Discomfort (2330)
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Event Date 01/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported that a patient underwent a scapholunary ligament reconstruction on (b)(6) 2017 due to a scapholunar dissociation.The surgery was performed with an arthrex reconstruction set (internal brace) augmented with ecrl tendon strips, transfixation with k-wire.The patient had good joint cartilage conditions at this time.After the first surgery, the patient suffered from persistent discomfort and renewed dissociation as well as the development of large lysis zones in the area of the screw anchorage of the ligament reconstruction.In a ct performed on the patient, only a radioulnar partially intact joint space was visible.The doctor decided to perform a revision surgery on (b)(6) 2019.When the anchors were removed, one was broken and the other was loose, causing them to grind and damage the cartilage in the radiocarpal joint.The tape showed itself prominently in the joint.The patient received a wrist stiffening due to the incident because the cartilage and bone were so seriously destroyed that a joint-preserving intervention with partial arthrodesis was no longer possible.Due to the arthrodesis of the wrist, the patient can no longer move the wrist.
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