SYNTHES BETTLACH PFNA-II BLADE L95 TAN; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
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Catalog Number 04.027.054S |
Device Problems
Migration or Expulsion of Device (1395); Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Date 09/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.He investigation could not be completed; no conclusion could be drawn, as no product was received.Device history record (dhr): manufacturing location: (b)(4).Manufacturing date: 03.Apr.2017.Expiry date: 01.Mar.2027.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.(b)(4).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 europe reports an event in (b)(6)as follows: the reported devices were used in the surgery for the femoral trochanteric fracture on (b)(6) 2017.At the third week after the surgery, the cut-out occurred; thus, the blade penetrated the femoral head.According the surgeon¿s opinion, the reduction was performed well during the surgery, and the postoperative x-ray images were fine.The surgeon also stated that the revision surgery (possible bipolar hip arthroplasty bha) must be considered if the blade penetration progresses.At this moment, natural bone healing is expected by the surgeon.Patient outcome ok.Concomitant devices: 1x 472.102s / 9820495 (pfna-ii ø11 xs 125° l170 tan), 1x 459.360vs / 5941663 (bolt ø4.9 self-tap l36 tav green), 1x 473.170s / l382493 (pfna-ii end cap extens.0 tan).This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Device 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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