CROSSROADS EXTREMITY SYSTEMS CROSSTIE INTRAOSSEOUS FIXATION SYSTEM; SCREW, FIXATION, BONE
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Model Number 1443-2511 |
Device Problems
Fracture (1260); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The reporter states that the surgeon implanted a 2.5 crosstie, part number 1443-2511 lot number 105448.The surgeon implanted it and was going to begin suture and grabbed the toe and the implant broke in half.The surgeon pulled one out and the other end was drilled out.Removal and reimplant was about 4 minutes long.An alternate implant was placed with minimal surgical delay.No non-conformances were identified in the investigation.The root cause is that the crosstie implant is a small diameter implant with potential to fracture if over-stressed.
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Event Description
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The reporter states that the surgeon implanted a 2.5 crosstie, part number 1443-2511 lot number 105448.The surgeon implanted it and was going to begin suture and grabbed the toe and the implant broke in half.The surgeon pulled one out and the other end was drilled out.Removal and reimplant was about 4 minutes long.An alternate implant was placed with minimal surgical delay.
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