Catalog Number UNK DRILL |
Device Problems
Break (1069); Entrapment of Device (1212)
|
Patient Problem
Limb Fracture (4518)
|
Event Date 07/07/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Investigation summary: the device associated with this report was not returned for evaluation, no confirmation of failure could occur.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
I have been advised that consultant surgeon, mr.(b)(6), had an issue seating a size 12 corail 12/14 amt collared stem implant, during a primary total hip replacement yesterday, (b)(6) 2021 at (b)(6) hospital.Following broaching with a size 12 broach and trialing satisfactorily, the definitive size 12 stem sat 3 cm proud from the calcar to the underside of the collar.K-wires were used to retrieve the stem as an extractor instrument was unavailable and surgery delayed by 2.5 hours.A c-stem amt 12/14 stem was implanted instead, once the corail was removed.
|
|
Manufacturer Narrative
|
Product complaint (b)(4).Investigation summary the device associated with this report was not returned for evaluation, no confirmation of failure could occur.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
|
|
Search Alerts/Recalls
|
|