Model Number N/A |
Device Problems
Fracture (1260); Difficult to Insert (1316); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical product: ms-ssr, msp procedure kit sterile right, 168401917b.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06556.
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Event Description
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It was reported that a driver broke twice.The surgeon drilled both cortical walls and began to insert the screw in the compression slot.While inserting the screw, the tip of the screw broke off.Subsequently, another set was opened for an additional driver.After the screw was fully inserted, the surgeon drilled again and the screw deformed the driver in a way that made it impossible for the surgeon to seat the screw.A third set was opened and the screw fully seated.There were no patient consequences as a result of the event.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to not be reportable as we do not have reporting responsibility for this device.The initial report was submitted in error and should be voided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06556 - 1.
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Search Alerts/Recalls
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