STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 1320-0111 |
Device Problem
Failure to Align (2522)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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During the locking of the gamma3 nail, misdrillings occurred.Surgical delay of 10min.Not longer.Medical procedure was completed successfully by performing free-hand-locking.
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Event Description
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During the locking of the gamma3 nail, misdrillings occurred.Surgical delay of 10min.Not longer.Medical procedure was completed successfully by performing free-hand-locking.
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Manufacturer Narrative
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The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.Although a real root cause could not be determined the alleged event is most likely caused due to a sub-optimal intraoperative procedure and has to be classified as user-customer-user error.Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check performed, which is required per ifu, it was concluded that the event was mainly based in the medical procedure.However, according to event description the procedure was completed successfully in freehand technique which is always an option.The reasons for misaligned drilling are various.Potential miss-targeting can also be caused by (but not limited to): loosening of the nail holding bolt during insertion of the nail.Repeated tightening of the nail holding screw prior to distal targeting / drilling is recommended.Not realized unintended loosening of the attachment knob (will lead to release of the drill sleeve).No use of drill with center tip / unfavorable bone contour.Drilling without drill guiding sleeve.Using blunt or damaged drill.High forces applied to the target device during drilling eventually leading to unintended distortion in the system of drill, sleeve, target device and nail.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.
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Search Alerts/Recalls
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