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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DIXI MEDICAL ANCHOR BOLT; ELECTRODE, DEPTH
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DIXI MEDICAL ANCHOR BOLT; ELECTRODE, DEPTH Back to Search Results
Model Number ANCHOR BOLT
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  malfunction  
Event Description
Event description: the anchor bolt was being inserted into the skull when the bolt threads didn't catch and advanced into the patients brain.Physician was able to retrieve the anchor bolt and an intra-operative ct was performed.Concern expressed that training and education was inadequate.Original intended procedure: stage 1 - bilateral twist drills and placement of stereotactic intracranial eeg electrodes with robotic stereotactic assistance rosa and airo portable ct scanner.
 
Manufacturer Narrative
The concerned procedure, realized on march 23rd, 2021, was the 3rd seeg procedure done by this center with dixi medical depth electrodes, and the 2nd procedure done by the neurosurgeon.A dixi medical representative was present during the procedure.This seeg procedure consisted to place 13 depth electrodes inside the brain of the patient, in order to locate the epileptogenic focus via the recording of the brain electrical activity.For each electrode, the implantation scheme is the same.During this procedure, the 12 first electrodes have been placed without difficulties.The problem appeared during the use of the last depth electrode, especially during the positioning of the last anchor bolt.It was observed during the procedure, the skull was pierced with a conmed drill (cordless) with dixi drill bit kip-acs-515 whose diameter is associated to the anchor bolt.The conmed drill appeared to have a lack of power, resulting in difficulty for the user to pierce the skull.The hole obtained had a diameter larger than expected, and then not adapted to the anchor bolt.When the neurosurgeon wanted to place the anchor bolt, it was not possible due to the diameter of the hole.The anchor bolt passed through the skull and advanced into brain tissue.The physician was able to recover the anchor bolt without any consequence for the patient.The corresponding depth electrode was not placed.A request has been made to return the device to the manufacturer, for technical investigation.These data will allow dixi medical to complete the analysis for this investigation.
 
Manufacturer Narrative
He concerned procedure, realized on (b)(6) 2021, was the 3rd seeg procedure done by this center with dixi medical depth electrodes, and the 2nd procedure done by the neurosurgeon.A dixi medical representative was present during the procedure.This seeg procedure consisted to place 13 depth electrodes inside the brain of the patient, in order to locate the epileptogenic focus via the recording of the brain electrical activity.For each electrode, the implantation scheme is the same.During this procedure, the 12 first electrodes have been placed without difficulties.The problem appeared during the use of the last depth electrode, especially during the positioning of the last anchor bolt.It was observed during the procedure, the skull was pierced with a conmed drill (cordless) with dixi drill bit kip-acs-515 whose diameter is associated to the anchor bolt.The conmed drill appeared to have a lack of power, resulting in difficulty for the user to pierce the skull.The hole obtained had a diameter larger than expected, and then not adapted to the anchor bolt.When the neurosurgeon wanted to place the anchor bolt, it was not possible due to the diameter of the hole.The anchor bolt passed through the skull and advanced into brain tissue.The physician was able to recover the anchor bolt without any consequence for the patient.The corresponding depth electrode was not placed.A request has been made to return the device to the manufacturer, for technical investigation.The device has not been sent to the manufacturer for investigation process.The analysis has been made on traceability information and information coming from the users about the event.The traceability analysis gives the following results: the part concerned comes from the dixi batch number 203868-26/20, and the component batch number 2002000783.All the incoming inspections (dimensional, visual, raw material certificate) were done and compliant with the acceptance criteria.All in-process controls were also done and compliant.Old customer complaints were analyzed and none of those involving this batch number.According to the traceability, all incoming and in-process inspections were done and acceptable.Moreover, among the 20 batch (i.E.200 anchor bolts) sold on the market no other customer complaint has been recorded up to now.Therefore, the expertise cannot conclude that the default is due to the manufacturing process or to the raw material.Unfortunately, the defected part could not be inspected so the reasons for such a failure is only based on the description of the event reported above.According to this, the drill used to made the skull hole receiving the anchor bolt didn't work properly.So, the user has applied to much effort on the drill bit and increasing the buckling phenomenon that might explain a not rounded or bigger hole.Therefore, the diameter of the hole was bigger than expected (bigger than the outer diameter of the anchor bolt) so this is a likely reason why the threads didn't catch the skull and the bolt passed through the skull and advanced into brain tissue.Basis on the expertise, the definition of the anchor bolt is not called into question, and no corrective action will be taken.
 
Event Description
Event description: the anchor bolt was being inserted into the skull when the bolt threads didn't catch and advanced into the patients brain.Physician was able to retrieve the anchor bolt and an intra-operative ct was performed.Concern expressed that training and education was inadequate.Original intended procedure: stage 1 - bilateral twist drills and placement of stereotactic intracranial eeg electrodes with robotic stereotactic assistance rosa and airo portable ct scanner.
 
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Brand Name
ANCHOR BOLT
Type of Device
ELECTRODE, DEPTH
Manufacturer (Section D)
DIXI MEDICAL
2a route de pouligney
marchaux-chaudefontaine, doubs 25640
FR  25640
MDR Report Key12391356
MDR Text Key283418222
Report Number3014527920-2021-00001
Device Sequence Number1
Product Code GZL
UDI-Device Identifier03664539000671
UDI-Public03664539000671
Combination Product (y/n)N
PMA/PMN Number
K170959
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberANCHOR BOLT
Device Catalogue NumberACS-025SMS-10
Device Lot Number203868-26/20
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/10/2021
Initial Date FDA Received08/31/2021
Supplement Dates Manufacturer Received05/10/2021
Supplement Dates FDA Received09/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age39 YR
Patient Weight78
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