|
Model Number 5018-5-150 |
Device Problem
Shipping Damage or Problem (1570)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/14/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown, it was not shipped to the hospital.
|
|
Event Description
|
As reported: "in a case where the apexpin sharp end should have been shipped, the blunt end was shipped in error.Finally, another company's product was used, but there was a 30-minute delay.".
|
|
Event Description
|
As reported: "in a case where the apexpin sharp end should have been shipped, the blunt end was shipped in error.Finally, another company's product was used, but there was a 30-minute delay.".
|
|
Manufacturer Narrative
|
***correction - please refer to h6 results & conclusion codes.The reported event wrong part delivered to customer (surgeon ordered a sharp end apex pin by sales rep.But the sales rep.Ordered a blunt end apex pin for the surgeon by distribution) could be confirmed, since distribution confirmed the issue and launched a nc for further investigation of the event.
|
|
Search Alerts/Recalls
|
|
|