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Catalog Number 3003940001 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This is a combination product.(b)(4).Report source, foreign - event occurred in (b)(6).Pictures have been received.The reported event was confirmed as it can be seen that the inner cement pouch sealing is damaged and that cement powder leaked outside the inner pouch.The product analysis can't be performed as the product was not returned.The complaint is related to a well-known event, previously evaluated and investigated.No further investigation is required as per 21 cfr part 820.198 complaint files ¿(b) and (c).Investigation results concluded that the reported event was due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that, during the surgery, the inner sterile packaging was found opened.In addition it was reported that the doctor used a new product to complete the surgery.As reported, the position of powder leakage is ad angle.As reported the product cannot be returned to (b)(6) as it does not comply customs regulations.No adverse event was reported as a result of the malfunction.
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Search Alerts/Recalls
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