Catalog Number 0580-1-374 |
Device Problems
Product Quality Problem (1506); Out-Of-Box Failure (2311); Manufacturing, Packaging or Shipping Problem (2975); Mechanics Altered (2984)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The customer reported via the sales rep that when they were attempting to use the exeter stem, the trunion protector was mis-shapen and could not be used.The surgery continued without delay as a second device was available.
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Manufacturer Narrative
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An event regarding a damaged spigot protector involving an exeter stem was reported.The event was confirmed.Method & results: device evaluation and results: the 2 lugs of the spigot are bent: one lug is slightly bent whereas the second lug is more bent with a fracture initiation.There is a bulge of material of the top of this second lug.The angle of this second lug is bent, as if it had been crushed.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: a review of the complaint history database shows that there have been no similar events for the reported lot.Conclusions: the investigation concluded that the root cause of this event was due to a manufacturing issue with the spigot supplier to (b)(4).The supplier investigation concluded the device escaped inspection.
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Event Description
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The customer reported via the sales rep that when they were attempting to use the exeter stem, the trunnion protector was mis-shapen and could not be used.The surgery continued without delay as a second device was available.
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Search Alerts/Recalls
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