Catalog Number 2110-135-004 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Udi - (b)(4).Medical product - std brl lag scrw 12.5x115mm , item 236115 lot 2017010792.Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01082.
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Event Description
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The hiploc plate hole is too small for the screw to go through.
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Event Description
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Hiploc plate and screw could not be assembled.
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Manufacturer Narrative
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(b)(4).The product relating to the reported event has been returned to biomet (b)(4) for evaluation.A review of the manufacturing history records for the hiploc plate from this event has not reported any abnormalities or deviations.A review of the complaint database found 17 similar complaints reported for this item code.The returned hiploc plates have been confirmed as non-conforming.The internal barrel on the hiploc plate has been confirmed as undersized through dimensional checks.A supplier corrective action report, (b)(4), has been raised on sanatmetal to investigate their manufacturing processes in relation to the non-conformance.A (b)(4) has been raised to investigate receipt and release of product.Product hold has been initiated: (b)(4).A hhe has been completed: (b)(4).
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Search Alerts/Recalls
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