Catalog Number 3003920001 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicate that (b)(4) products désignation refobacin bone cem r 20 ref.3003920001, batch b702aa2303 were manufactured on (21th july 2017).The device manufacturing quality record (of6108015) indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the complaint issue (complaint category inner cement pouch open sealing) event described in the complaint.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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Event Description
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It was reported that inner sterile packaging was found to be opened.This issue was detected during the surgery.This event involves 10 products.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The product has been received at the manufacturer.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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Event Description
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It was reported that inner sterile packaging was found to be opened.This issue was detected during the surgery.This event involves 10 products.No adverse events have been reported as a result of the malfunction.
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Event Description
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It was reported that inner sterile packaging was found to be opened.This issue was detected during the surgery.This event involves 10 products.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated: b4, g4, h2, h6, h10.The product analysis show that the product has been returned in original box with the outer pouch, labels and the monomer ampoule.The inner pouch hasn¿t been returned.The event is not confirmed.The review of the device manufacturing quality record indicates that 959 products designation refobacin bone cement r 20 ref.3003920001, batch b702aa2303 were manufactured on (21th july 2017).The device manufacturing quality record (of6108015) indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the complaint issue (complaint category inner cement pouch open sealing) event described in the complaint.1 complaint has been reported over the batch number b702aa2303.According to the available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.A customer letter will be sent to the complainant in order to explain the issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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Search Alerts/Recalls
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