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Catalog Number 04.038.405S |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Failure of Implant (1924); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Additional product code: ktt.(b)(4).Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).Device history records review was conducted.The report indicates that the: dhr review for part # 04.038.405s lot # 7892515, release to warehouse date: 06 march 2015 , expiration date: 01 january 2025 , 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 10.5 ti tfna fenestrated helical blade 105mm 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.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 on an event in (b)(6) as follows: it was reported that the helical blade of the titanium femoral nail advanced (tfna) was placed in the patient.Three months post-operatively the blade protruded in the acetabular causing a cut-out effect even thought it had the proper indication of the implant.Patient status is satisfactory.Revision surgery was performed.The devices were implanted on (b)(6) 2017 by a (b)(6) patient with osteoporosis.After the surgery the patient presented pain and an x-ray was taken where the doctor noticed the displacement of the blade.The implants were revised on (b)(6) 2017.The patient is stable and presents a good process.This complaint involves 1 part.Concomitant reported part: 1x tfna femoral nail ø 10mm (part 04.037.045s lot 9969594).This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Internal review update: (b)(6) 2017 - medical examiner confirms the migration of the blade and its perforation through the for moral head cortex.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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A review of the returned device was completed.The returned fenestrated helical blade is part of the trochanteric fixation nail advanced (tfna) system and referenced in the tfn advance surgical technique.The fenestrated helical blade allows for augmentation with cement which is intended for fractures in the proximal femur with poor bone quality and/or increased risk of fixation failure at the implant/bone interface.Device and x-ray review: the helical blade was received intact with surface wear consistent with implant and explant.Concentrated areas of wear were noted on the superior and inferior surfaces of the proximal end of the blade.No cement was observed on the device.No sharp edges or discrepancies which may have impacted the cut-out condition were observed.Replication of the complaint condition is not applicable as the issue concerns helical blade cut out.The provided x-rays were evaluated.The migration of the blade and its perforation though the femoral head cortex were confirmed.Thus, the complaint condition is confirmed and consistent with the reported condition.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 10.5 ti tfna fenestrated helical blade 105mm 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.Drawing review: based on the date of manufacture the drawings reflecting the current and manufactured revision were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use.Risk assessment review: the trochanteric fixation nail - advanced (tfna) design and clinical risk management (dcrm), was reviewed and found to adequately address the complaint condition.A definitive root cause could not be determined as the loading parameters over the implant duration (approximately 3 months) are unknown.Various factors impact the forces encountered by the implants such as, but not limited to, fracture reduction, bone healing, surgical technique/placement, and patient factors (compliance, activity level, and comorbidities).However, many of these factors are unknown.It was reported that the procedure was for a (b)(6) year old patient with osteoporosis.During the investigation it was also noted that there is no evidence to suggest that cement was utilized with the blade.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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