Model Number 55-IN-0110 |
Device Problems
Break (1069); Loose or Intermittent Connection (1371); Device Fell (4014)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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Patient information - unknown.Occupation - other; distributor.Serious injury - although there was no patient injury or delay to the procedure related to this event, it is being reported as a serious injury due to medical intervention required to remove the broken tip from the patient.Device manufacture date - unknown without lot identification.
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Event Description
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It was reported that a procedure was performed on (b)(6) 2020, "utiilizing" the reform poct system.During normal use of the rod reduction rocker (55-in-0110), the distal end of the instrument broke loose of the shaft and fell into the "paitient".It was retrieved by using a bayonet forcep.No injury to the patient and no real time wasted as a tower reducer was used to finished the job quickly.
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Event Description
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It was reported that a procedure was performed on (b)(6) 2020, utilizing the reform poct system.During normal use of the rod reduction rocker (55-in-0110), the distal end of the instrument broke loose of the shaft and fell into the patient.It was retrieved by using a bayonet forcep.No injury to the patient and no real time wasted as a tower reducer was used to finished the job quickly.
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Manufacturer Narrative
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H3 device evaluation: evaluation with magnification found that there is a thin weld present.Root cause it attributed to the component diameters being too large, resulting in small seam chamfers that did not allow for enough filler weld, resulting in it being buffed off at finishing.Design changes were introduced in effort to prevent recurrence.Review of device history records found (b)(4) pieces of lot: 00075ptr were released for distribution on 10/9/2018 with no deviation or anomalies.Two-year complaint history review (3.24.2018-3.24.2020) found two previous reports of this nature for this lot.Product from this lot will be reworked.
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Search Alerts/Recalls
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