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Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Code Available (3191)
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Event Date 01/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown cup, unknown liner, unknown head, unknown stem.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location if the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during surgery, the grub screw for stabilizing the rotation of the hip screw could not be inserted with the existing instruments.It was subsequently rejected.The operation ended without the grub screw.Both the handle and the modular screwdriver were damaged during distal locking.According to the surgeon, the patient's cortex was very hard attempts have been made and additional information on the reported event is unavailable.
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Event Description
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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