Model Number 5450-50-501 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2022 |
Event Type
malfunction
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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.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 outside packaging of depuy mv cement with gent.Was not damaged.When the surgeon opened the box, the product was damaged.The liquid component had crystallized within its packaging and there was loose glass.When the surgeon saw this, he removed the product from the operating room before it reached the sterile field.The product did not harm the patient nor did it reach the sterile field.Doe: (b)(6) 2022.
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Manufacturer Narrative
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Product complaint # = > pc-(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.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3 and h4.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the product was returned to depuy synthes and sent to depuy uk r&d/mfg manufacturing site for evaluation.The depuy uk r&d/mfg team conducted a visual inspection of the returned device.Examination of the device confirmed the reported allegation, the device was received damaged inside the unopened inner package.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: retained blistered ampoule samples for this lot number were examined with no further examples of this failure mode discovered.Corrected: h3.
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Search Alerts/Recalls
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