Product complaint # (b)(4).Additional product code: hwc.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.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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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.The product was returned to depuy synthes and sent to manufacturing site: jabil: grenchen for evaluation.The jabil: grenchen team conducted a visual inspection of the returned device.Visual analysis of the returned sample was performed on cortscr ø3.5 self-tap l18 ti.A manufacturing record evaluation was performed for the finished article lot and it was confirmed that above lot#96p9574 was part of the bounding of the jbl-nr-0009605.The underlying issue within the nr was defective sealing & contamination of product packages.An use-as-is disposition was executed for this lot within the corresponding jnj nr-0160760.The dimensional inspection was not performed since it was not applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the cortscr ø3.5 self-tap l18 ti.The root cause of the complaint condition can be confirmed due to the manufacturing issue.The received condition of the cortscr ø3.5 self-tap l18 ti confirmed that the package was empty.Jabil: grenchen initiated non-conformance (nc): jbl nr-0009605 to further evaluate and determine the manufacturing error in detail that led to the complaint condition.Any further actions will be determined under jbl nr-0009605 opened at jabil: grenchen.Jnj nr-0160760 is opened to track and document jbl nr-0009605.Any further corrective/preventive actions if required will be captured under nr-0160760.Device history lot - part: 404.818, lot: 96p9574, manufacturing site: grenchen, release to warehouse date: 16 march 2021.A manufacturing record evaluation was performed for the finished article lot and it was confirmed that above lot#96p9574 was part of the bounding of the jbl-nr-0009605.The underlying issue within the nr was defective sealing & contamination of product packages.An use-as-is disposition was executed for this lot within the corresponding jnj nr-0160760.Device was used for treatment, not diagnosis.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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