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Catalog Number 224035 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that during the acl surgery, in a 4.0mm dia nail 4.0mmx35cm, the clamp broke while suturing the cuff.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Manufacturer Narrative
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The device was not returned for evaluation; therefore, a device analysis could not be performed.As the part and batch number information provided did not match into the system, a device history record review could not be performed.A review of complaint history did not reveal similar events for the listed device over the previous 12 months.The part and batch number information provided did not match into the system, however the review was performed and did not reveal similar events for the batch.This failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with the inspection procedure, it includes the verification of part configuration to print.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique and/or excessive forces.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Search Alerts/Recalls
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