MAUDE Adverse Event Report: MEDTECH SAS LEKSELL FRAME ADAPTOR; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3009185973 - 2023 - 00017.Log files were provided and reviewed by a subject matter expert (sme).No permanent electrodes were left implanted; therefore, the reported inaccuracy could not be verified through the logs alone.However, the registration and verification process were still analyzed.The registration analysis shows that registration was performed with markers positioned on the leksell frame pins instead of actual compatible bone fiducials.This registration method is an off-label use.Per section 2.4.1.2 bone fiducials registration: "this method requires the use of bone fiducials which are implanted into the patient¿s skull.Refer to the list of compatible devices for the available compatibility with bone fiducials models." additionally, review of the registration verification indicates that the points were either validated with important errors detected or skipped entirely.While the user was most likely unable to reach anatomical points due to the presence of the frame, section 2.4.2 accuracy verification procedure of the user brain manual states: ¿the user must position the pointer probe or the optical distance sensor on several relevant anatomic landmarks of the patient¿s head and verify the appropriate matching of the navigated position on the preoperative images.¿ ¿it is highly recommended to carry out the verification in order to obtain optimal performance.¿ since the recommendations for registration and verification were not followed there is no guarantee that the registration is accurate regarding the patient¿s head.No errors were found in the logs that would indicate that the rosa software caused or contributed to the inaccuracy.The reported issue was confirmed by a field service engineer (fse) who was present to assist the procedure.The leksell frame moved during registration and during the procedure, which affected the accuracy of the electrode placement.While the effects of the first shift were corrected by importing a new reference exam and reattempting registration, the effects of the second shift were not detected until the electrodes were placed for awake testing.The system successfully passed all tests during the next preventative maintenance visit.Device history records were reviewed and no discrepancies related to the reported event were found.During the investigation, the reported inaccuracy was confirmed.A shift in the leksell frame adaptor was identified by the fse and user error with the registration and verification process were identified in the log analysis.However, it cannot be determined which issue, or the extent, that caused or contributed to the inaccuracy.Therefore, the definitive root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that awake dbs procedure using the rosa robot was forced to be aborted due to inaccuracy of stereotactic guidance.During awake testing, surgical team was not able to find desired results of stimulation and came to the conclusion some variable forced the inaccuracy of the robotic arm.No permanent electrodes were left implanted in the patient and the patient was not harmed due to the inaccuracy.This caused a two (2) hour delay and the procedure will be rescheduled.No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were (update/corrected).Corrected: g4.Updated: g3; h2.
Event or Problem Description
No further information at the time of this report.

• Brand Name: LEKSELL FRAME ADAPTOR
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 18417989
• Report Number: 3009185973-2023-00026
• Device Sequence Number: 6808172
• Product Code: HAW
• UDI-Device Identifier: 03760244033598
• UDI-Public: (01)03760244033598
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K214065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ROSAS00348
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown