SYNTHES GMBH TI DHS/DCS LAG SCREW 12.7MM THREAD/105MM; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
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Catalog Number 480.050S |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The investigation could not be completed.No conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective, and/or 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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the customer received the incorrect product.The customer received a product that indicated a length of 105mm on the packaging, but there was a length of 125mm indicated on the delivery form.There is no further information available.This report is for one (1) ti dhs®/dcs® lag screw 12.7mm thread/105mm.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).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 subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device history lot sterile part: part: 480.050s, lot: 7l21422, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 25.Aug.2020, expiry date: 01.Aug.2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part: part: 480.050, lot: 57p1937, manufacturing site: balsthal, release to warehouse date: 28.Jul.2020.A manufacturing record evaluation was performed for the finished device lot number 57p1937 and no non-conformances were identified 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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