DEPUY SYNTHES SPINE VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number 199721000 |
Device Problems
Device Damaged by Another Device (2915); Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Twelve (12) verse dual innie correction key set screws [product code: 1997-21-000] were also returned to the chu for evaluation.Visual examination revealed that all twelve set screws demonstrated some indication of torn and sheared off threads.Noted damage suggests that the correction key set screws were likely not properly seated during insertion and inadvertently cross threading occurred coupled with unexpectedly high amounts of force being placed on the threads resulting in them being torn.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.A definitive root cause for the threads becoming torn and sheared off the correction key set screws cannot be positively determined.However, a likely root cause is that the correction key set screws were likely not properly seated during insertion and inadvertently cross threading occurred coupled with unexpectedly high amounts of force being placed on the threads resulting in them being torn.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.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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Event Description
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Feedback from surgeon: by now i have done 5 operations with the expedium verse implants.Four (4) out of 5 were deformity surgery.The last case i have done was on tuesday this week.The case: (b)(6) , male patient with severe cerebral palsy (gmfcs- level 5) w/ a 120° neurogenic thoraco-lumbar scoliosis with shoulder and pelvis obliquity.Aim of surgery: improve sitting and nursing of the patient.Surgery: correction spondylodesis t2-ilium.Problem with the implants: in the scoliosis cases with no severe curves (<60-70°) the implants work pretty well , because they do not get stressed specially the screw head is not stressed! but in severe cases (more than 80-90° and severe rotation of the vertebra) the screw heads seem to have more space in the verse quick stick sleeve and the verse quick stick tube , the verse facilitator and the flex clip reducer and that¿s why the blocker (flat screws, correction screws ) do no run correctly in the screw head and cant.The screw head extension is may be too soft.The diameter of the reichel sleeve, the tube etc.May be too wide.
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Manufacturer Narrative
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Verse dual innie correction key setscrew is a concomitant device.There is no indication that the set screw caused or contributed to the event.The tearing of the set screws was caused by the damaged flex clip and flex clip reducer which will be classified as torn.Torn set screws have been changed to concomitant upon further evaluation.Set screws were originally reported as torn based on information available.The complaint was discussed during a smt meeting on (b)(6) 2017.After inspecting the returned flex clip the device showed signs that the plastic bushing between the two parts of the inner reducer sub assembly was damaged.This indicates that the inner tube was advanced beyond the zero etch line on the outer clip/sleeve and then bottomed out on the outer sleeve.As the surgeon continued to apply more torque inner reducer sub assembly, the plastic bushing collapsed and the spring tip of the most distal component of the inner reducer sub assembly deformed inward, occluding the access to the screw head, making passing the set screw impossible.It is hypothesized that the surgeon did not have the flex clip fully clipped onto the screw head, which therefore allowed the surgeon to believe he had fully reduced the rod, but could not get the set screw to start in the screw head.In response the surgeon applied more torque to the reducer which only caused the device to deform as described above which then continued to make getting the set screw started impossible.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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