Model Number 130760138 |
Device Problems
Off-Label Use (1494); Device-Device Incompatibility (2919)
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Patient Problem
Not Applicable (3189)
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Event Date 02/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: the device was examined by the manufacturer and a report was received stating the root cause deterioration during installation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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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Product complaint # (b)(4).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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It was reported that this was a rtsa (reverse total shoulder arthroplasty) treating cta (cuff tear arthroplasty) on (b)(6) 2020.The surgeon screwed in the glenosphere (130760138) with the help of a guide pin.Because the glenosphere was not able to be fit in, the surgeon hammered it, which failed and required reinsertion.The glenosphere and the guide pin were removed for the reinsertion.But the guide pin did not go through the glenosphere.Another guide pin with a smaller diameter could go in.As the surgeon thought that the glenosphere¿s shaft might have distorted, s/he completed the procedure with a replacing glenosphere less than 30-minute surgical delay.There was no harm to the patient.The device was the first use when the issue occurred.
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Search Alerts/Recalls
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