STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø12X420 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
|
Back to Search Results |
|
Catalog Number 18251242S |
Device Problem
Mechanics Altered (2984)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/07/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Once the investigation has been completed any additional information will be reported in a supplemental report.
|
|
Event Description
|
The pharmacist assistant at the hospital, reported that it was not possible to lock up the implant.When placing the implant, proximal locking was not possible.There was an increase in surgical time approximately by one hour and a half to two hours.
|
|
Manufacturer Narrative
|
The product inquiry had listed the nail as the primary product.The instruments, because allegedly fully functional, were considered to be concomitant items.Review of the dhr / inspection records for the device in question revealed no discrepancies.The device was documented as faultless prior to distribution.A (pre-operational) functional check revealed no deficiency of the nail¿s drill holes.All drill holes were passed without nail contact.The labelling include that every unit, interaction between implant and instrument(s), must be checked prior to every surgery ¿ paying attention to a firmly tightened nail holding screw.The operative technique describes in detail the functional check.Upon functional check of the returned nail it turned out that an, accidentally and not realized, cross threaded fixation screw may have led to the reported.It was possible to reproduce the found drill marks exactly in slight torsional displacement (a poorly tightened nail holding screw may have caused damages in more axial (proximal or distal) direction.In order to ease fixation of handle and target device a so called fixation screw clamp (catalogue #18060273) has been developed to further improve the product handling; oblique insertion of the fixation screw into the corresponding internal thread of the targeting arm will be avoided, as after clamping this device onto the metal part of the targeting arm a straight insertion is ensured.This fixation screw clamp is available since 2010.Based on the above facts and considering that confirmed pre-operative check had been performed it was concluded that the case was attributed to a suboptimal intraoperative procedure.Surgical delay was most double checking the targeting accuracy intra-operatively and by providing new equipment to finalize the surgery.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.With available information no deficiency of the nail was verified.
|
|
Event Description
|
The pharmacist assistant at the hospital, reported that it was not possible to lock up the implant.When placing the implant, proximal locking was not possible.There was an increase in surgical time approximately by one hour and a half to two hours.
|
|
Search Alerts/Recalls
|
|
|