Catalog Number PHD03N |
Device Problem
Fracture (1260)
|
Patient Problem
No Information (3190)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Patient identifier: not provided (b)(4).Age at time of the event, date of birth not provided.Gender not provided.Patient weight not provided.Lot number not provided.
|
|
Event Description
|
Doctor reported that the phd03n tip (hex) that engages the screw snapped off during a laboratory procedure.
|
|
Manufacturer Narrative
|
No product was returned for inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed and the following information was identified: p-iis086gi rev.F 11/2015 and instsm rev d 02/16.Information identified: pick-up and delivery of implant: care must be taken when inserting the implant placement driver tip into the implant.A very low rpm must be used as you approach the internal connection of the implant with the driver tip to properly align the internal hex of the implant with the external hex of the driver.Press down firmly to engage the implant securely.Complaint alleges the screw driver was fractured during use.Complaint is non-verifiable without return of the product.A root cause for this complaint could not be determined.
|
|
Search Alerts/Recalls
|