Catalog Number 3095040 |
Device Problem
Chemical Problem (2893)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).No 510k as device is not marketed in the united states under this product code, but the same/similar product is marketed in the us under a different product code.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
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Event Description
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Smartset ghv was highlighted to have a different consistency after mixture.Surgeon described the cement to be lumpy and powdery despite following the cement mixing instructions.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, "smartset ghv was highlighted to have a different consistency after mixture.Surgeon described the cement to be lumpy and powdery despite following the cement mixing instructions." lot: 3986438; manufacturing date: 09 nov 23; expiry date: 31 oct 24; quantity: (b)(4).There were two product non-conformances on this lot, neither of which had an adverse effect on the performance of the cement.The retained samples were tested in a temperature and humidity-controlled laboratory.Dough time: 55 sec.Mix characteristics: as expected.Setting time: 10 min 10 sec.The cement mixed and behaved as expected for the product type and met the appropriate control specification (ref ms-010 smartset ghv gentamicin bone cement master specification).Setting time was tested using tm-t150.The recorded setting met the control specification of 8.5 ¿ 12.5 (8 min 30s to 12 min 30s).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.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation was performed for the finished device 3095040, lot 3986438, and no non-conformances / manufacturing irregularities were identified.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.According to the information received, "smartset ghv was highlighted to have a different consistency after mixture.Surgeon described the cement to be lumpy and powdery despite following the cement mixing instructions." lot: 3986438 manufacturing date: 09 nov 22 expiry date: 31 oct 24 quantity: (b)(4).There were two product non-conformances on this lot, neither of which had an adverse effect on the performance of the cement.The retained samples were tested in a temperature and humidity-controlled laboratory.Dough time: 55 sec mix characteristics: as expected.Setting time: 10 min 10 sec.The cement mixed and behaved as expected for the product type and met the appropriate control specification (ref ms-010 smartset ghv gentamicin bone cement master specification).Setting time was tested using tm-t150.The recorded setting met the control specification of 8.5 ¿ 12.5 (8 min 30s to 12 min 30s).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.If additional information is made available, the investigation will be updated as applicable.Device history lot : a manufacturing record evaluation was performed for the finished device 3095040, lot 3986438, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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