Catalog Number 254400519 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Information (3190)
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Event Date 01/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).Followup with the complainant has been conducted for the lot number, and the information is not available.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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Event Description
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Attune balanced femoral sizer, attune balanced sizer distractor and attune balanced sizer ps foot were used on the tka surgery of (b)(6) 2007.During the balanced distractor was inserted to the balanced sizer, it was hard to pull down the balanced sizer.The operation was continuing with the measured sizer used-instead of it.The balanced sizer which inserted into the half way of the patient knee was not removed finally, so the doctor succeeded for removing it with hitting the above part of the balanced distractor by the metal hammer.After removing it, it was possible to insert the balanced sizer into that with a little hard to do.
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Manufacturer Narrative
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(b)(4).This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.
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Manufacturer Narrative
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This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.
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Manufacturer Narrative
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The complaint states attune balanced femoral sizer, attune balanced sizer distractor and attune balanced sizer ps foot were used on the tka surgery of (b)(6) 2007.During the balanced distractor was inserted to the balanced sizer, it was hard to pull down the balanced sizer.The operation was continuing with the measured sizer used-instead of it.The balanced sizer which inserted into the half way of the patient knee was not removed finally, so the doctor succeeded for removing it with hitting the above part of the balanced distractor by the metal hammer.After removing it, it was possible to insert the balanced sizer into that with a little hard to do.A complaint database search did not identify any anomalies.The investigation confirmed the failure mode as reported.The devices were reviewed by bioengineering and a report was received stating; in the complaint part, two of the prongs are noticeably deformed, bending inwards into the slot for the balanced distractor.This allows the locking nut to be easily removed from the device.The heavily deformed prongs were likely caused by the mallet impaction as stated in the complaint description.The complaint description also states that assembly of the balanced sizer was difficult prior to impaction, showing that some deformation of the prongs was likely present already.Root cause: use error post market surveillance is per (b)(4).The complaint shall be closed with a justified conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (b)(4).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.
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Search Alerts/Recalls
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