SYNTHES MONUMENT 10MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY
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Catalog Number 04.037.028S |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problems
Failure of Implant (1924); Non-union Bone Fracture (2369); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(b)(4).The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record (dhr) review was performed for the reported subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: jul 23, 2015.Expiration date: jul 31, 2025.The review showed that there were no issues during the manufacture of the product lot that would contribute to this complaint condition.No non-conformance reports (ncrs) were generated during the production of the subject device.Component part reviewed included: component parts reviewed: 04.037.912.2 - lock prong 125 degree, tfna bp-55 lot - 9423211; 04.037.912.4 - wave spring, shim ended bp-55 lot - 7722139; 04.037.912.3 - tfna lock drive bp-58 lot - 9831604; 21127 - raw material lot bp-80 lot - 7820273.Raw material provided by supplier.Certificate of test for titanium ingot was provided met specification.Inspection sheet for in-process/inspect dimensional/final and inspection sheet - tfna assembly inspection met inspection acceptance criteria.(b)(4).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 reported an event in (b)(6) as follows: it was reported that revision surgery was performed on (b)(6) 2017 due to a broken trochanteric fixation nail ¿ advanced (tfna), two (2) broken distal cross bolts and nonunion (right femur).The patient was initially implanted on (b)(6) 2016.It is unknown when the broken hardware and nonunion were discovered by x-ray.The nail broke at the proximal aperture.Both distal cross bolts broke with the most distal bolt breaking in two (2) places, leaving a piece of the bolt wedged in the nail.The tfna [lag] screw was intact.During the (b)(6) 2017 revision surgery, the broken nail was extracted with difficulty as the threads below the aperture were not engaging with the extraction instrument.The tfna devices were explanted.A reaming/irrigation/aspiration (ria) procedure was performed.The patient was revised with an unknown device (12 x 380 x 130mm).The surgery was delayed by 120 minutes due to the difficulty removing the tfna nail.The surgeon reported that the patient¿s postoperative assessment is good.Concomitant medical products: 2x 5.0mm locking screw, part unk, lot unk; unk quantity of tfna screws, part unk, lot unk; 1x unk new nail, part unk, lot unk; 1x 04.038.195s lot unk.This report is 1 of 2 for (b)(4).
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Manufacturer Narrative
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The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.The provided x-rays were reviewed and it was noted a bolt is broken, based to this the complaint is confirmed.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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Update to concomitant device: tfna fenestrated screw 95 mm - sterile (part 04.038.195s, lot 7872225, quantity 1).
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Manufacturer Narrative
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Additional narrative: a manufacturing investigation action was conducted/performed.The report indicates that: the following products was received on jun 22, 2017: qty (1) nail 04.037.028s (2 broken pieces), qty (1) large screw 04.038.095, qty (1) small screw p/n unknown, qty (1) small screw (broken) p/n unknown.Furthermore, we have also received a tfna screw (04.038.195 / 7872225): as this part is not responsible for the breakage of the nail, no further investigation will be done.Based to the received x-ray, we are able to say that a bolt is broken, based to this the complaint is confirmed.Raw material lot bp-80 lot - 7820273.Raw material provided by supplier (b)(4) company.Certificate of test for titanium ingot was provided by howmet castings meet specification upon visual inspection, the article received is in used condition, based to the damage at the head of the screw, the article and lot no.Are not readable any more.After reviewing the complaint and also reviewing the physical parts that were provided, it was determined that this complaint is confirmed.This assessment is obvious because the nail received has been broken into two pieces.The length of the nail was measured using a scale.It was confirmed that the measured length of 380 mm confirms that this is a 380 mm nail (nails are manufactured in 20 mm increments ¿ 320 mm, 340 mm, 360 mm, etc.) there is no way to measure the oblique hole, as it is broken and the oblique hole appears partially in one piece and partially in the other piece.The two pieces do not fit clearly together, therefore not allowing any kind of valid measurement of the oblique hole.The large screw is p/n 04.038.195, lot #7872225.Lot was manufactured on 5-jan-2015.Its length was measured to be 95 mm, which is the specified length.The screw is intact and unbroken.There is normal wear and tear on the part.There are some scratches noticed.This could happen during the removal of part.Based on examining the nail, and reviewing the complaint, the cause of the break is undetermined.Based to the mentioned findings, no further investigation will be done.No product fault could be detected.No corrective action required.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.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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