The reported event is confirmed, cause unknown.The ureteral stent was returned without the original packaging.An evaluation was completed by futurematrix on 10may2022.The breakage occurred from the suture porthole to the end of the stent.This kind of separation is seen when the suture is forcefully in the opposite direction from the stent.The suture was not provided for evaluation.As a 100% inspection was completed and the portholes are checked under 15x magnification prior to being sent to the customer, the stent is not believed to have been sent to the customer broken.A potential root cause for this event could be, "inappropriate package design".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "improper handling technique can seriously weaken the stent." "suture may be cut off prior to stent placement.Remove suture prior to placement for pediatric patients." "exercise care.Tearing of the stent can be caused by sharp instruments." "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." the actual/suspected device was inspected.
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