Model Number N/A |
Device Problems
Difficult or Delayed Positioning (1157); Fracture (1260); Difficult to Insert (1316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/12/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: patello-femoral joint (pfj) milling burr standard; p/n: 00592705000, l/n: 64497161; qty: 2.Milling handpiece; p/n: 00592704000, l/n: 13010572.Milling handpiece; p/n: 00592704000, l/n: 08010227.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00855.
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Event Description
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It was reported during surgery the first milling guide became loose and the surgeon was force to break it to release the handle.Subsequently, the second milling guide was used and would not seat properly.No adverse events have been reported as a result of the malfunction.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being filled to relay additional information, which was unknown h3: customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted. .
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Search Alerts/Recalls
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