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Catalog Number 04.038.310S |
Device Problems
Migration or Expulsion of Device (1395); Unintended Movement (3026)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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Device used for treatment, not diagnosis.Patient age & weight not provided for reporting.(b)(4).Device malfunctioned post-operatively and was explanted (b)(6) 2017.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review (dhr) has been requested.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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It was reported that a trochanteric fixation nail advanced (tfna) hardware removal and revision is scheduled for (b)(6) 2017 due to helical blade back-out.The original procedure was performed on (b)(6) 2017.Subsequently, the helical blade backed out.The nail, helical blade and distal locking screw remain implanted.Revision surgery was performed on (b)(6) 2017.Surgery completed successfully.The nail was cut with a saw for removal, so it is marred.There is 1 device in this complaint concomitant devices reported: nail (part # 04.037.160s, lot # 7949025, quantity 1) distal locking screw (part # unknown, lot # unknown, quantity 1).This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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The returned implant was inspected at customer quality and the complaint was unconfirmed as no x-rays were provided.The helical blade was returned showing signs of post manufacture damage, consistent with removal.The concomitant nail also shows signs on post manufacture damage, consistent with being hit with a saw during removal.This complaint could be replicated as this event happened in situ and there are multiple potential variables that could have contributed to this event.A visual inspection, dimensional analysis, drawing and device history record review were performed as part of this investigation.Material and hardness testing is not applicable at this time as they were tested at the time of manufactured and confirmed to have no issues through the dhr review.A visual inspection of the helical blade showed signs of post manufacture damage, consistent with removal.The concomitant nail also shows signs on post manufacture damage, consistent with being hit with a saw during removal.The shaft, where engagement with the nail would occur, measured with in specifications, 9.235-9.240 mm, at 9.24 mm.Drawing was reviewed and was determined to be suitable for the intended design, application and dimensional conformity when used as recommended.A review of the device history record revealed no complaint related anomalies.The complaint is adequately addressed by the risk assessment.While a definitive root cause could not be determined, it is possible that while a definitive root cause could not be determined, it is possible that poor bone quality led to a collapse around the device.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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X-ray review by cq engineer: based on the first x-ray it can be seen the helical blade had indeed backed out which may contributed to the complaint condition.The second x-ray no issues 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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Manufacturer Narrative
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Udi: (b)(4).Returned to manufacturer,: subject device has been received and is currently in the evaluation process.Dhr review for part # 04.038.310s lot # h195887.Release to warehouse date: 24 october 2016.Expiration date: 30 september 2026.Manufacturing site: (b)(4).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 110mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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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