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OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM TI BROAD LCP® PLATE 14 HOLES/260MM; APPLIANCE, FIXATION, NAIL
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| Catalog Number 426.641 |
| Device Problem
Break (1069)
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| Patient Problems
Failure of Implant (1924); Limited Mobility Of The Implanted Joint (2671)
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Event Type
Injury
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Manufacturer Narrative
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Patient¿s date of birth/ age and weight are unknown.Date of postoperative plate breakage is unknown.510k: this report is for one (1) unknown locking compression plate (lcp) large fragment plate.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is attorney.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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Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient was initially implanted with 14-hole locking compression plate (lcp) large fragment plate and stable-angle screws on an unknown date to treat a femoral shaft spiral fracture.Initial surgery was completed without complications.Post-operatively on (b)(6) 2015, the condition of the patient worsened with restriction of mobility and load-bearing capacity of the right leg.An x-ray taken detected that the lcp had broken between two cerclage cables.Revision surgery was performed on an unknown date.Concomitant devices reported: stable-angle screws (part # unknown, lot # unknown, quantity unknown), cable/ wire (part # unknown, lot # unknown, quantity unknown).This report is for one (1) unknown locking compression plate (lcp) large fragment plate.This is report 1 of 1 for complaint (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.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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Updated concomitant devices: cortex screw (part 414.834, lot 8194590, quantity 1); cortex screw (part 414.830, lot 8222074, quantity 1); locking screw (part 413.355, lot 8292447, quantity 1); locking screw (part 413.348, lot 8272785, quantity 1); locking screw (part 413.334, lot 8237764, quantity 1); locking screw (part 413.338, lot 8226121, quantity 1); locking screw (part 413.340, lot 9472178, quantity 1); locking screw (part 413.342, lot 9275376, quantity 1); locking screw (part 413.336, lot 8203682, quantity 1); locking screw (part 413.334, lot 8237764, quantity 1); screw (part/lot 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.Part and lot number were provided, but are not recognized in the synthes database 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.A device history record (dhr) review was conducted for part: 426.641, lot: 9003902: manufacturing site: grenchen, release to warehouse date: 02.June 2014: the device history record shows this lot of 9 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate 16258 was reviewed and the used material was according to iso-5832-2 specification for implants for surgery.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.The investigation result is a summary from the (b)(4) engineering examination.Sem examination: when examining the fracture surfaces (part a and b) of the fragment 1 using the scanning electron microscope (sem), the areas of fracture initiation and the direction of fracture propagation were identified.The crack started at the upper side of the plate and ran into the material.After breaking, the two fragments rubbed against each other causing some slight destruction of the fracture surfaces (abraded and shiny areas).At a higher magnification, fatigue striations were observed at the crack propagation zones.Each striation represents the successive positions of an advancing crack front, originating from cyclic loads (load and unload during walking).The presence of these striations is a clear indication of a fatigue process.The fracture surface predominantly showed a mixed fracture with parts of a structural fracture (crystallographically oriented fracture) and some parts of transcrystalline cleavage fracture.Structural fracture is typical for pure titanium and indicates a higher load.Ln the event of cleavage fractures, the material is separated perpendicular to the greatest tensile stress by overcoming the cohesion forces of the metal lattice, usually without plastic deformation.Sem observations and findings showed that the plate failure was caused by fatigue and overload.Conclusions: based on the topography of the fracture surface, we can conclude that the implant was subjected to moderate and high dynamic bending loads (one sided).Constantly alternating load cycles (during walking/movement) led to the fatigue of the material, then to a first crack and finally to the overload respectively to the fatigue fracture of the lcp.The plate could not resist the applied force which finally led to the material overload / fatigue failure.Postoperative activities of the patient and instability of the fracture situation (cerclage wire) may have played a certain role, too.We found no evidence of material or manufacturing defects.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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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