SYNTHES USA 5.0MM CANNULATED VA LOCKING SCREW/80MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
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Catalog Number 02.231.680 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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The investigation could not be completed; no conclusion could be drawn.The lot number provided could not be verified; therefore, further investigation cannot be performed.One of the following device(s) was received: 4.5mm va-lcp curved condylar plate (part # 02.124.411 | lot # 9237095); 5.0mm cannulated va locking screw (part # 02.231.690| lot # unknown); 5.0mm cannulated va locking screw (part # 02.231.685| lot # unknown); 5.0mm cannulated va locking screw (part # 02.231.680| lot # unknown) - qty.2 ; 5.0mm cannulated va locking screw (part # 02.231.675| lot # unknown); 5.0mm va locking screw (part # 02.231.244| lot # unknown); 5.0mm va locking screw (part # 02.231.238| lot # unknown); 4.5mm cortex screw (part # 214.842 | lot # unknown) ; 4.5mm cortex screw (part # 214.836 | lot # unknown).A total of (b)(4) implants were received.All devices show signs of being implanted.The plate is intact with cosmetic scratches along its surface.All (b)(4) screws had damage to the stardrive recess consistent with insertion and removal.The threads on 42mm cortex screw were rolled.The exact cause for the screw loosening could not be determined.A visual inspection, functional test, complaint history review, and a drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Since no x-rays were received, the complaint condition was unable to be confirmed.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 a patient underwent an orif (open reduction internal fixation) of a supracondylar femoral fracture on (b)(6) 2015.Hardware failure occurred sometime after the initial procedure.X-rays showed that the five 5.0 cannulated screws were backing out at the head of the plate.On (b)(6) 2015, the surgeon removed all hardware (plate and 9 screws).The patient will have further surgery on a date to be determined.Also reported, the patient underwent an orif (open reduction internal fixation) of a supracondylar femoral fracture on (b)(6) 2015.Hardware failure occurred sometime after the initial procedure.X-rays showed that the distal 5.0 cannulated va locking screws were backing out of the head of the plate.On (b)(6) 2015 the screws that were backing out were replaced with new 5.0 va cannulated locking screws.On (b)(6) 2015, the surgeon removed all hardware (plate and 9 screws) secondary to failure again.The sales consultant stated that the 5.0 va cannulated locking screws (5) that were previously replaced on (b)(6), were backing out at the head of the plate once again.The patient status is unknown at this time.The patient will have further surgery on a date to be determined for definitive treatment.This report is 2 of 5 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Additional information: patient medical record number is (b)(4).Additional and corrected information was received on august 26, 2015.A product development investigation was performed for the subject device (part number 02.231.680, 5.0mm cannulated va locking screw/80mm, lot number unknown).The subject device was received showing signs of having been implanted.The screw has damage to the stardrive recess consistent with insertion and removal.The exact cause for the screw loosening could not be determined.A visual inspection, functional test and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The returned device was determined to be suitable for the intended use when employed and maintained as recommended.Since no x-rays were received, the complaint condition was unable to be confirmed.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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Additional information was received on (b)(4) 2015.It was reported that a patient underwent an orif (open reduction internal fixation) of a supracondylar femoral fracture on (b)(6) 2015.On an unknown date after the initial procedure, x-rays showed that the distal 5.0 cannulated va locking screws were backing out of the head of the plate.On (b)(6) 2015 the screws that were backing out were replaced with new 5.0 va cannulated locking screws.On (b)(6) 2015, the surgeon removed all the hardware (plate and nine screws) due to secondary failure.It was further reported that the five, 5.0 va cannulated locking screws that were previously replaced on (b)(6) 2015 were backing out at the head of the plate once again.The patient status is unknown at this time.The patient will have further surgery on a date to be determined for definitive treatment.The first revision surgery performed on (b)(6) 2015 is addressed under a separate complaint, (b)(4).This complaint and associated medwatch reports address the second revision surgery performed on (b)(6) 2015.This report is 3 of 6 for (b)(4).
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