Model Number 1506-70-004 |
Device Problems
Off-Label Use (1494); Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922); 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 01/20/2022 |
Event Type
malfunction
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Event Description
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Customer found inner and outer plastic packaging stuck together.The packaging was malformed after sterilization.The products was not opened with sterile technique but the surgeon elected to utilize the implant.No reported surgical delay or patient harms.
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Manufacturer Narrative
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Product complaint # (b)(4).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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Manufacturer Narrative
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Product complaint (b)(4).This product is being reported based on the potential for compromised sterility, though not confirmed at this time.The package was (opened in a sterile field/has a double barrier of sterile protection in which the outer barrier remained sealed).If further information is received regarding the event, a follow-up report will be provided at that time.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.H10.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.Visual examination of the provided photographic evidence denoted that the inner and outer blister of the packaging was melted/deformed.On the provided evidence, the tyvek lid was no lo longer attached to the blister seal.Since it is not possible to determine whether the lid was removed before or after the product was received by the costumer, sterility cannot be definitively confirmed.Based on provided evidence, it cannot be observed any condition on blister's seal and/or tyvek lid which denoted any difficulty to open the package.Since damages on the blister were observed before implantation, indications were not followed as specified.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: product code 150670004, work order (b)(4) was manufactured on 15 oct 2021.Total of (b)(4) were manufactured to specification.There were no deviations associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.Device history review: a manufacturing record evaluation was performed for the finished device [lot/serial] number, and no non-conformances related to the reported complaint condition were identified.
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Search Alerts/Recalls
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