MAUDE Adverse Event Report: MEDTECH SAS SEEG DRILL ADAPTOR 2.45MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer has indicated the product will be returned to zimmer biomet for investigation.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the screw driver (not zimmer biomet's) was getting stuck on three (3) different adaptors.The resident had to push harder for bolt to pass through adaptor and then bolt plunged.The case had to be canceled.Three (3) electrodes had been placed and got removed before craniotomy that needed to occur as the bolt was very deep inside the brain.The bolt was retrieved.No additional procedure has been scheduled or performed to date.Attempts have been made and there is no further information at this time.
Event or Problem Description
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 updated/corrected updated: b1; d4; d9; g1-2; h2; h3; h6.The subject devices were not returned to the post market surveillance team for evaluation, and no pictures were provided to support claim.The bolt was removed, and the patient condition was fine.The program development associate confirmed the reported event.There was no deviation from the workflow.The patient had a previous craniotomy performed so the patient condition may have contributed to the bolt plunging, but this cannot be determined to be the definitive cause for the reported event.Device history records were reviewed and no discrepancies related to the reported event were found.Based on the investigation, the reported event was verified only by the program development associate.However product was not returned for evaluation, no pictures or additional information was provided.A definitive root cause could not be identified with the information available.There is no evidence confirming that the rosa devices malfunctioned or contributed to the adverse event.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
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.

• Brand Name: SEEG DRILL ADAPTOR 2.45MM
• 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21037640
• Report Number: 3009185973-2024-00019
• Device Sequence Number: 7656495
• Product Code: HAW
• UDI-Device Identifier: 03760244031600
• UDI-Public: (01)03760244031600(11)180716
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 07/23/2025

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: ROSAS00082
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 05/07/2025; 07/23/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 05/29/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown