Catalog Number 130738203 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2023 |
Event Type
malfunction
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Event Description
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While setting up for a shoulder surgery, it was identified that the implant on the shelf humeral pe cup 38/+3 standard was damaged to the extent where the sterilization was deemed to no longer be protected.There was no delay or impact in anyway to the patient as new implant was available before incision commenced.
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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 (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).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device product code - 130738203, lot number - 5542949, and no non-conformances / manufacturing irregularities were identified.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 - 130738203, lot number - 5542949, and no non-conformances / manufacturing irregularities were identified.
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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.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.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.H3.
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Manufacturer Narrative
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Product complaint (b)(4) investigation summary were setting up in advance for a shoulder surgery scheduled for the day with product specialist when it was identified that the consignment implant on the shelf humeral pe cup 38/+3 standard (ref: (b)(4) , lot: 5542949, exp: 30/04/2028) was damaged to the extent where the sterilization was deemed to no longer protected.This part was set aside, theatre staff were advised and a replacement implant was sourced from a nearby hospital.There was no delay or impact in anyway to the patient as new implant was available before incision commenced.It is not known when the packaging for the product was damaged, whether this was before it was received by the hospital or whilst the product was on the hospital shelf.Have advised nz depuy synthes customer service of todays issue and will return the stock to them once pc number issued.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned dxtend stand pe cup d38 +3mm revealed that the cardboard packaging was damage and presents a hole at the bottom left.It is noteworthy to mention that the shrink wrap was not found ripped, therefore it can be concluded that there is no impact to the sterility of the device.A manufacturing record evaluation was performed for the finished device product code - 130738203, lot number - 5542949, and no non-conformances / manufacturing irregularities were identified.The root cause of the complaint condition cannot be traced to a manufacturing facility.However, once the product leaves depuy synthes control, it is unknown what environment conditions the packaged products are exposed to during that time.Therefore the suspected cause is traced to transport/storage outside of depuy synthes control.The overall complaint was confirmed as the observed condition of the dxtend stand pe cup d38 +3mm would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a manufacturing record evaluation was performed for the finished device product code - 130738203, lot number - 5542949, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: corrected: h3.
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Search Alerts/Recalls
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