Catalog Number 250620103 |
Device Problems
Peeled/Delaminated (1454); Mechanical Jam (2983); Scratched Material (3020)
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Patient Problem
Not Applicable (3189)
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Event Date 03/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.
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Event Description
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It was reported that the blade of the tibial cemented conical reamer (p/n: 250620103) was caught in the sri attune stemable tibia tower (manufactured by ksi) and it was stuck and the fixed tibia plate was come off during tka surgery on (b)(6) 2019.The surgeon re-placed it and repeated the same process.However, the blade and tower were scraped, and the metal powder was appeared.Thus, the surgeon stopped using the instruments to prevent health damage to the patient.The surgery was completed within a 30 minutes surgical delay.There was no adverse consequence to the patient.It seemed to be an issue of accuracy of the tibia tower and the conical reamer.No further information is available.
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Manufacturer Narrative
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(b)(4).Evaluation of the returned device confirms deformation to the reamer.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: evaluation of the returned device confirms deformation to the reamer.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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