Catalog Number 273.125 |
Device Problem
Break (1069)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Additional product code ¿ hwc.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received (b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 eu reports an event in (b)(6) as follows: it was reported that a fracture of a proximal femoral nail (pfn) and femoral neck screw occurred postoperatively.Revision surgery was required and both devices were reportedly explanted.The implant and explant dates are currently unknown.There is no additional information available at this time.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) ¿ manufacturing date: november 9, 2012.The review of the dhr showed no deficiencies.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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Event Description
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Update: it was further reported that all of the parts were not removed during the revision.The broken devices may have been the only items explanted.
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Manufacturer Narrative
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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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The provided x-rays were reviewed by the manufacturer and it was noted that a broken nail and screw could be observed.It was reported that an explant procedure was performed on (b)(6) 2016.During the procedure, the pfn was extracted proximally using the impactor.It was apparent that the distal section of the nail had fractured at the site of the locking bolt and remained in the femur.Since the remains of the nail and the antirotation screw were completely enclosed in the bone marrow/femoral neck, it was decided to leave the residual implants in situ.
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Manufacturer Narrative
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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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Manufacturing investigation evaluation: the returned nail is broken and deformed.A review of the device history records has been completed with no reported irregularities.The diameter of the returned device was inspected and found to be within tolerance and according specifications.The complaint is confirmed, but not valid from a manufacturing standpoint.Product investigation summary: this complaint condition is likely the result of complications during the healing process (i.E.Non-union, delayed union) or an overloading situation of different factors.The complaint is determined not to be a result of a detected manufacturer or material deficiency.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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