Model Number 2217-50-041 |
Device Problems
Break (1069); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 the pinnacle cup inserter broke while impacting cup.It was unknown if there was any surgical delay.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: an analysis of the product could not be performed, since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed, as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
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Event Description
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Additional information received.A.Was there a surgical delay? if yes, what is the duration of the delay? no delay.B.Was there any adverse consequences that affected the patient, because of the reported event? no.C.Did it break into two or more pieces? were all the broken pieces retrieved from the patient.Broke into two pieces.D.Which part of the device was broken? the back of the cup impactor broke off, after we impacted out cup.E.Please provide the lot number of the reported device(s).Lot number was scratched and not visible.
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Search Alerts/Recalls
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