STRYKER GMBH DRILL TIP FIXATION PIN STAR ANKLE 2.4MM X 80MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
|
Back to Search Results |
|
Catalog Number 9330018 |
Device Problems
Break (1069); Difficult to Advance (2920)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/14/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Once the investigation has been completed any additional information will be reported in a supplemental report.
|
|
Event Description
|
It was reported by stryker rep that during a ankle prothesis surgery, the surgeon encounter resistance while trying to pass the pins (933-0018) through the talar window trial (926-0062).The first pin enter with resistance.The second one broke and a part was blocked into the patient.The surgeon was able to remove the pins and used screws instead of the pins to complete the surgery.The surgery was completed successfully, the surgical delay was less the 15 minutes.He stated that the pins passed successfully in an other talar window trial of the kit but not in the 926-0062.
|
|
Event Description
|
It was reported by stryker rep that during a ankle prothesis surgery, the surgeon encounter restistance while trying to pass the pins (933-0018) through the talar window trial (926-0062).The first pin enter with resistance.The second one broke and a part was blocked into the patient.The surgeon was able to remove the pins and used screws instead of the pins to complete the surgery.The surgery was completed successfully, the surgical delay was less the 15 minutes.He stated that the pins passed successfully in an other talar window trial of the kit but not in the 926-0062.
|
|
Manufacturer Narrative
|
The reported event of non-mating instruments (drill / trial) and breakage was confirmed.No deviations were found during review of the manufacturing and inspection documents (dhr).The drills were documented as faultless prior to distribution.No deficiency found during dimensional inspection of the returned product.The shaft of the returned drill had become damaged by contact with the damaged drill holes in the trial ¿ ether by pre-damaged trial or during the procedure of mal-aligned drilling.The damage patterns indicate that the broken instrument was operated in counter-clockwise direction (unscrewing) under high torsional force application whilst the squares became broken.This was caused during operating in left direction after the drill had stuck and in order to remove the drill.Summarizing above findings the event was caused by unsuitable handling by the user.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 were no actions in place related to the reported event for the subject product.No similar complaint has been reporterd within the same lot # l36122.No non-conformity was identified.The event was not linked to a deficiency of the device.
|
|
Search Alerts/Recalls
|
|
|