Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 06/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
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Event Description
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Event happened during the surgery when the tip of the drill bit fractured inside the patient's bone.
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Manufacturer Narrative
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Event description: it was reported that during surgery the tip of the drill bit fractured inside the patient's bone.The surgeon tried removing these pieces but could not do so.Product evaluation: - visual examination: the visual examination confirms the reported event; the proximal part of the drill bit was fractured.The fracture is located at the beginning of the cutting area of the drill.The edge of the fracture surface is worn and deformed.Review of product documentation: - device purpose: this device is intended for treatment.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.- raw material certificate: the raw material certificate was reviewed with no anomalies noted.- the appropriate surgical technique for the ncb distal femur was reviewed.It is mentioned that in case of good bone quality it is recommended to drill the cortex with a 4.3mm drill bit.Moreover in all figures of the drilling process, a drilling perpendicular to the bone surface is illustrated.5.Conclusion: it was reported that during surgery the tip of the drill bit fractured inside the patient's bone.The surgeon tried removing these pieces but could not do so.Based on the investigation the reported event can be confirmed.The review of the manufacturing records did not identify any deviations or anomalies during manufacturing.Review of the surgical technique showed that it is recommended to use a drill bit with a larger diameter to drill the cortex in case of a good bone quality.In this case there was a possibility to use a larger diameter drill bit (according to the product portfolio) than the preferred one.Therefore one possible root cause is a breakage of the drill due to the application of excessive forces.However, based on the available information an exact root cause could not be determined.
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Event Description
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Investigation result is available now.
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Manufacturer Narrative
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Additional information received on (b)(6) 2020.Additionals: b5.Corrections: b4, g4, g7, h10.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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Event Description
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During surgery the tip of the drill bit fractured and was left in the patient's bone as the surgeon could not remove it.The procedure was completed using another drill.No additional adverse event reported due to the drill bit being left in the patient.No additional intervention planned.
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Search Alerts/Recalls
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