STRYKER ORTHOPAEDICS-MAHWAH EXETER RASP SIZE 1 37.5/44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 0580-3744-1 |
Device Problems
Break (1069); Fracture (1260); Mechanical Jam (2983)
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Patient Problem
Injury (2348)
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Event Date 10/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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When using the femoral bark, the instruments broke inside the patient, making the withdrawal process difficult.It was necessary to use instruments from another supplier to drill the broken instruments and to remove them, increasing the time of surgery in 2 hours.
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Manufacturer Narrative
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An event regarding crack/fracture involving an exeter rasp was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: not performed as no medical records were received for review with a clinical consultant.Product history review: not performed as the lot information provided was invalid.Complaint history review: not performed as the lot information provided was invalid.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as product lot code, product return, images of the device taken when the alleged event was identified as well as operative notes are required to complete the investigation for confirming the event and determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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When using the femoral bark, the instruments broke inside the patient, making the withdrawal process difficult.It was necessary to use instruments from another supplier to drill the broken instruments and to remove them, increasing the time of surgery in 2 hours.
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Search Alerts/Recalls
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