Model Number 1987-27-318 |
Device Problems
Device Damaged Prior to Use (2284); Separation Problem (4043)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Date 11/27/2018 |
Event Type
malfunction
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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 a brand new medium srom 18mm poly was opened and the poly was disassociated from the medal hinge.Poly was in two pieces as was unusable.A surgical delay of 20 minutes was noted.Doe: (b)(6) 2018.
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Manufacturer Narrative
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(b)(4).No device associated with this report was received for examination.Depuy synthes 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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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).Investigation summary: the received device was forwarded to raynham quality engineer for evaluation.Review of the received device revealed the device was disassembled, however, noted damage consistent with suspected use of excessive force was identified.The need for corrective action was not established.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.H10 additional narrative: corrected: h6 (patient,device).No code available (3191) is used to capture surgery prolonged.
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Search Alerts/Recalls
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