WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY
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Model Number 04.037.031S |
Device Problem
Disassembly (1168)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Due to intra-operative issues, the device was not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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It was reported that on (b)(6) 2018, a patient underwent a trochanteric fixation nail advanced (tfna) procedure.During the surgery, the surgeon tried to take off the percutaneous radiolucent insertion handle after having placed and locked down the tfna femoral nail, titanium alloy and lag screw.However, the connecting screw for insertion handle would not release from the nail.The patient¿s leg was abducted and the connecting screw could not be removed.The surgeon then removed the instrumentation and implants.A new second nail of the same part and different sized lag screw were inserted, and another new second connecting screw and insertion handle were used.The same issue occurred.The connecting screw became stuck to the nail while taking off the second insertion handle.The surgeon was able to disengage the connecting screw from the nail.The second nail and lag screw remained implanted in the patient.It was noted that the nail was not fitting on properly, and that the tips of both insertion handles had become bent or torqued.It was also noted that the screw inserter bent at the handle and the helical blade/screw coupling screw bent at the tip of the threads.There was an unknown surgical delay reported.Additional medical intervention was required.The patient outcome was also unknown.The procedure was successfully completed.Concomitant device reported: trochanteric fixation nail advanced (tfna) screw 100mm - sterile (part 04.038.100s, lot h406590, quantity 1); trochanteric fixation nail advanced (tfna) screw 110mm - sterile (part 04.038.110s, lot 7859799, quantity 1).This is report 8 of 8 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history record (dhr) review: item: 04.037.031s; lot: h473583; mfg qty: 6; mfg date: 18 oct 2017; mfg location: monument; exp date: 30 sep 2027; review of dhr found that all required inspections were performed and passed per inspection sheet.There were no nonconformances (ncs) or reworks generated during the production of this lot.The product was processed per gamma 25-40kgy at ethicon endo-surgery.Documentation indicates product was processed and passed per requirements.No nonconformance records (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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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