Catalog Number 545050501 |
Device Problem
Chemical Problem (2893)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that the gmv cement hardened too quickly and was not able to shoot in a cement gun.
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Manufacturer Narrative
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Product complaint # : (b)(4).Dmf# - 13704.Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.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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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Added: a1, a3, b5, d10 concomitant 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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Additional information received.A.How was the cement prepared for use? it was mixed in a mixing tower for 1 minute.It was then mixed for 30 seconds in a mixing tower the next attempts & still hardened too quickly before putting into a cement gun.B.What equipment was used to prepare / mix the cement? hospital-owned stryker mixing tower.C.What was the timing to mix and the time between mixing and setting? mix was 1 minute and time between mixing and setting was 2-3 minutes.D.What equipment was used to deliver the cement? was going to be a cement gun.E.Can you provide the quantity used of the cement product? qty of 5 was used in the procedure.
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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.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 is received at a later date, the investigation will be updated as applicable.
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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, it was reported that the gmv cement hardened too quickly and was not able to shoot in a cement gun.This happened in 3 attempts mixing cement during the case.Afterwards a total mix was done with a batch of cement and the same thing happened.It's almost like the gmv cement is acting like the ghv cement.A manufacturing record evaluation was performed for the finished device product code:545050501 lot number:4047303, and no non-conformances / manufacturing irregularities were identified.Lot: 4047303.Manufacturing date: 23 jan 23.Expiry date: 31 dec 24.Quantity: (b)(4).Product checked: retained samples.Required testing: tm-t150 cement setting time.There are no non-conformances associated with this batch.Dough time: 02 min 48 secs.Mix characteristics: ok.Setting time: 10 min 29 sec.The cement mixed and behaved as expected for the product type and met the appropriate control specification (ref ms-008 smartset gmv gentamicin bone cement master specification).Setting time was tested using tm-t150.The recorded setting met the control specification of 9.0 ¿ 13.5 (9 min to 13 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 product code:545050501 lot number:4047303, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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