Model Number SHORT SPINE ADP - SST |
Device Problems
Mechanical Jam (2983); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Udi# : unknown.The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.
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Event Description
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It was reported that upon inspection of the second set of instruments at porter hospital, it was discovered that the 6ø cannula would not pass through the short spine instrument adaptor.
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Manufacturer Narrative
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It was reported that upon inspection of the second set of instruments at porter hospital, it was discovered that the 6ø cannula would not pass through the short spine instrument adaptor, (rosas00112; (b)(6)).Device was returned at manufacturing site on 14-jun-2021 and was inspected.Inspection showed that some marks are visible inside the adaptor that could explain the impossibility to insert a cannula.This type of event was already reported and investigated through ou design inquiry management process.A new design of the part was developped and distributed on the field.The event described in the complaint is confirmed.
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Event Description
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It was reported that upon inspection of the second set of instruments at porter hospital, it was discovered that the 6ø cannula would not pass through the short spine instrument adaptor.
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Search Alerts/Recalls
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