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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
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| Model Number 02.124.408 |
| Device Problem
Break (1069)
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| Patient Problem
Impaired Healing (2378)
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Event Type
Injury
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Manufacturer Narrative
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Date of event is unknown.Other procodes: hrs, hwc.Lot number is unknown.Date of implant is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.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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Event Description
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It was reported that the patient underwent surgery on an unknown date due to a polytrauma.After the surgery, the patient was reported to be noncompliant and walked earlier than instructed by the surgeon.A nonunion of the distal femur fracture occurred and x-rays were taken of the distal femur.The plate was found to be broken along the shaft and one locking screw was broken just below the head of the screw.No fragments were generated from the broken parts.All original hardware (the plate, an unknown number of locking screws and unknown number of cortex screws) was removed on (b)(6) 2018 and replaced with an autograph using ria (reamer irrigator/aspirator), a retrograde nail with a spiral blade, a distal interlocking screw and two proximal interlocking screws.Revision completed successfully with no delay.Patient status is unknown.Concomitant products: locking screws (part/lot unknown, quantity unknown), cortex screws (part/lot unknown, quantity unknown).This report is for a 4.5mm va-lcp curved condylar plate/8 hole/195mm/right.This is report 1 of 2 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.A device history record (dhr) review was conducted for part no.: 02.124.408, lot no.: l316119: manufacturing location: mezzovico, release to warehouse date: 24.Feb.2017: the plate was made from forging blank 60067383 lot no l304326 which was made from smb medical sa.Release to warehouse date: 02.Feb.2017: no non-conformance reports (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.A product investigation was conducted.The returned device is part of the 4.5mm va-lcp curved condylar plate system and is indicated for buttressing multi fragment distal femur fractures per relevant technique guide.Customer quality investigation: the following investigations were performed: broken: at customer quality, the returned 4.5 mm va-lcp curved condylar plate (part: 02.124.408, lot: l316119, mfg: 24-feb-2017) was visually inspected and the returned plate was observed to be broken at the 5th and 6th variable angle combi holes.Additionally, minor scratches were observed on the overall length of the plate.The received condition agree with the complaint description and the complaint was confirmed.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for va-lcp curved condylar plate and determined to be suitable for the intended design and application when used as recommended.Dimensional analysis performed at the portion proximal to broken region measured plate thickness and falls within the specification per relevant drawings.While no definitive root cause could be determined it is likely that any unintended forces encountered by the device during patient¿s post-op activities could have contributed to this complaint condition.Additionally, it was mentioned in the complaint description that the patient was reported to be noncompliant and walked earlier than instructed, therefore failure to provide sufficient healing time could have contributed to additional forces on the device which could have led to this broken complaint condition during the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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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Concomitant devices reported: 5.0mm va locking screw 85mm (02.231.085, lot l637298, quantity 1), 5.0mm va locking screw 90mm (02.231.290, lot l562483, quantity 1), 5.0mm va locking screw 90mm (02.231.290, lot l432647, quantity 1), 4.5mm cortex screw 36mm (214.836, lot number unknown, quantity 3), 4.5mm cortex screw 40mm (214.840 lot number unknown, quantity 1).
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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.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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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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.Part number of the concomitant device 5.0mm va locking screw 85mm corrected from 02.231.085 to 02.231.285.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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Concomitant devices reported: 5.0mm va locking screw 85mm (02.231.285, lot l637298, quantity 1), 5.0mm va locking screw 90mm (02.231.290, lot l562483, quantity 1), 5.0mm va locking screw 90mm (02.231.290, lot l432647, quantity 1), 4.5mm cortex screw 36mm (214.836, lot number unknown, quantity 3), 4.5mm cortex screw 40mm (214.840 lot number unknown, quantity 1).
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