Model Number 1822-0931S |
Device Problem
Difficult to Remove (1528)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 12/15/2021 |
Event Type
malfunction
|
Event Description
|
As reported: "the nail could not be removed and remained in the patient's body.A surgical delay of 30 minutes was reported.Update: the procedure was a planned removal due to bone healing.The event was not resolved.The nail could not be removed.At this time, the surgeon does not plan to make another attempt to extract the nail.".
|
|
Manufacturer Narrative
|
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.
|
|
Event Description
|
As reported: "the nail could not be removed and remained in the patient's body.A surgical delay of 30 minutes was reported.Update: the procedure was a planned removal due to bone healing.The event was not resolved.The nail could not be removed.At this time, the surgeon does not plan to make another attempt to extract the nail.".
|
|
Manufacturer Narrative
|
The alleged event was not confirmed.Although, the unit is allegedly still implanted; no evidence like medical records were provided.Review of dhr, labelling, capa databases and risk analysis did not identify any new discrepancies.There are no open actions in place related to the reported event for the subject product.It was reported: ¿the nail could not be removed and remained in the patient's body.¿.The procedure was a planned removal due to bone healing.The labelling points out ¿¿the x-ray ruler ¿ may be used to determine nail diameter and length¿.If the nail has been inserted too far, it has to be repositioned.¿ ¿ at a later stage it was confirmed that ¿the nail was too short and although it had been extended with end cap, the extractor could not be attached to the nail.¿ as the bone had healed the product had fulfilled its tasks as intended.With above information the cause of the event was regarded as not device related but rather user related.
|
|
Search Alerts/Recalls
|