SYNTHES GMBH FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Catalog Number 04.168.000S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Limb Fracture (4518)
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Event Date 01/18/2021 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility name: (b)(6) hospital.Part: 04.168.000s, lot: 61p9870, manufacturing site: (b)(4), release to warehouse date: july 16, 2020, expiry date: july 1, 2030.A manufacturing record evaluation (mre) is not required, as based on evaluation findings the damage is not resulting from manufacturing issue.Complaint is confirmed as we are able to confirm complaint description, as the collapse is visible.Furthermore, the fns construct including the locking, screw show no issue or/and damage, based on the received pictures.Additionally, there is no allegation of a device malfunction reported.Furthermore, for a further examination it is necessary for us to receive the implant back.Product was not returned therefore no further investigation possible.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 (information or/and material), 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 patient experienced post-op pain due to a fracture of the subtrochanteric femur.On (b)(6) 2020, the patient underwent the osteosynthesis surgery with the fns.On approximately (b)(6) 2020 the patient fractured the subtrochanteric femur and felt pain.The surgeon followed up and it was determined to leave it was as it was because the patient had a callus and was walking.On (b)(6) 2021 the patient was climbing the stairs and felt pain.It was confirmed that the fracture had occurred at the distal screw.On (b)(6) the patient underwent the revision surgery and the fns implants were removed and tfna long was implanted.Concomitant devices reported: bolt f/fem neck syst f/construct length (part number 04.168.290s, lot 34p2944, quantity 1); antirotscr f/fem neck syst f/construct l (part number 04.168.490s, lot 46p9817, quantity 1); lockscr ø5 self-tap l36 tan (part number 412.212s, lot 5l90939, quantity 1).This report involves one (1) femoral neck system plate 1 hole - sterile.This is report 1 of 4 for (b)(4).This product complaint is related to (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 investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned for investigation.Therefore, no further investigation possible.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 (information or/and material), 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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Search Alerts/Recalls
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