Model Number N/A |
Device Problems
Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Initial report.Report source, foreign event occurred in (b)(6).Postal code: (b)(6).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 by the surgeon that the system was not user friendly and that the instrumentation was incomplete.The im adapter was missing.31-60 minutes delay of the surgical procedure reported.No harm of the patient or the user was reported.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, b4, b5, d1, d2, d4, d10, g4, g7, h1, h2, h3, h5, h10.Additional information received: the shortage of the instruments in the set was noticed during a procedure.Product information received: device name: oxf fem drill gde lat im adapt, item: 32-423400, lot: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.No photographs available.The surgery was completed with other device: item: 32-423300.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.Product has not been returned.
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Event Description
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It was reported by the surgeon, that the system was not user friendly and that the instrumentation was incomplete (lack of instruments).The im adapter was missing.The malfunction caused a 60 minute delay to surgery.No impact or consequences to the patient or the user was reported.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to make a correction.Section d1 & d2 corrected: product involved in the incident is an unknown oxford im instrument.No further information about the product has been provided until now.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 by the surgeon that the system was not user friendly and that the instrumentation was incomplete.The oxford im adapter was missing.31-60 minutes delay of the surgical procedure reported.No harm of the patient or the user was reported.
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Event Description
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It was reported by the surgeon, that the system was not user friendly and that the instrumentation was incomplete (lack of instruments).The im adapter was missing.The malfunction caused a 60 minute delay to surgery.No impact or consequences to the patient or the user was reported.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to make a correction.The following sections were updated: b4, b5, g4, g7, h1, h2, h10.Upon reassessment of the reported event, it was determined an mir report should not have been submitted under the current manufacturer.This event will be reported by medwatch facility warsaw biomet - (b)(4).Therefore, biomet uk ltd.Will not be sending any follow-ups regarding this product.
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Search Alerts/Recalls
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