STRYKER ORTHOPAEDICS-MAHWAH CUP IMPACTOR BOLT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
|
Back to Search Results |
|
Catalog Number 1440-2011 |
Device Problems
Bent (1059); Insufficient Information (3190)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/04/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of the investigation.
|
|
Event Description
|
Instruments failed during surgery, primary left hip.On (b)(6) 2015, sales rep reported that the flexible reamer is bent.It was being used for a total hip.Surgeon put the reamer in without a guide pin and when he pulled it up the reamer was bent.No adverse effect to patient related to reamer.On (b)(6) 2015, sales rep reported that the magnetic bolt is frozen to the impacting handle.
|
|
Manufacturer Narrative
|
An event regarding difficulty disassembling the cup impactor bolt from the da cup impactor handle (pr) was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as medical records were not received.Device history review: not performed as the lot details were not provided complaint history review: not performed as the lot details were not provided.Conclusions: it was not possible to determine the root cause of the event based on the information provided.Addtional information such as return of the device and operative notes are need to complete the investigation.No further investigation is possible at this time.If further information or device is received, this investigation will be reopened.
|
|
Event Description
|
Instruments failed during surgery, primary left hip on 11-nov-2015, sales rep reported that the flexible reamer is bent.It was being used for a total hip.Surgeon put the reamer in without a guide pin and when he pulled it up the reamer was bent.No adverse effect to patient related to reamer.On 9-nov-2015, sales rep reported that the magnetic bolt is frozen to the impacting handle.
|
|
Search Alerts/Recalls
|
|
|