Catalog Number 2107-1014 |
Device Problems
Break (1069); Fracture (1260); Material Integrity Problem (2978)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/14/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of the investigation.
|
|
Event Description
|
When the surgeon would place the dome screw in the trident cup with screwdriver (500-11-48d), the tip of the screwdriver fractured in the dome screw thread(torx).The patient was not affected.The first cup was discarded and a new cup was opened and implanted in the patient with another screwdriver.Surgical delay of approximately 5-10 minutes.
|
|
Manufacturer Narrative
|
An event regarding a fractured hexalobular screwdriver tip from a trident driver shaft was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection of the returned device shows hexalobular tip of screwdriver was fractured.The fractured piece was not included with the returned driver shaft.The deformation to the driver indicates the tip was deformed while the device was being used to tighten a screw.Examination of the returned device with material analysis engineer indicated fracture consistent with a torsional overload condition.-medical records received and evaluation: a review of medical records was not performed as none were provided.No further information was requested as there is no indication the failure was related to patient factors.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed as per visual inspection of the returned device which shows that the hexalobular tip of screwdriver was fractured.The fractured piece was not included with the returned driver shaft.The deformation to the driver indicates the tip was deformed while the device was being used to tighten a screw.Examination of the returned device with material analysis engineer indicated fracture consistent with a torsional overload condition.
|
|
Event Description
|
When the surgeon would place the dome screw in the trident cup with screwdriver (500-11-48d ), the tip of the screwdriver fractured in the dome screw thread(torx).The patient was not affected.The first cup was discarded and a new cup was opened and implanted in the patient with another screwdriver.Surgical delay of approximately 5-10 minutes.
|
|
Search Alerts/Recalls
|