SYNTHES GMBH 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/80MM; PLATE, FIXATION, BONE
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Catalog Number 02.127.180 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Additional procode: hwc.Reporter is a synthes employee.Part: 02.127.180, lot: 45p6759, manufacturing site: (b)(4), release to warehouse date: march 26, 2020.A manufacturing record evaluation was performed for the finished device 02.127.180 lot: 45p6759 and no non-conformance's were identified.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that on an unknown date, the hospital received an empty package.The package was unbroken but had no screw inside it.This report is for a 3.5mm variable angle locking screw.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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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.H3, h6: the device was received, the investigation is in progress, 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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Manufacturer Narrative
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The received condition of the complaint bag is partially in accordance with the complaint description.The returned bag is empty, but the manufacturing investigation has detected a partial sealing of the bag itself.Even though it is stated, that the bag was ¿unbroken¿ in the complaint description.The partial sealing of the bag is considered the most likely cause of no part inside it.A manufacturing related issue is confirmed, at packaging step for the lot#: 45p6759.Therefore, this complaint is rated as confirmed.And valid.Further investigation will be carried out.Device history lot: part: 02.127.180, lot#: 45p6759, manufacturing site: grenchen, release to warehouse date: 26.Mar.2020.A manufacturing record evaluation was performed, for the finished device 02.127.180, lot#: 45p6759.And no non-conformances were identified.Device history batch: null; device history review: null.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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Search Alerts/Recalls
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