MAUDE Adverse Event Report: JJGC S.A. TWIST DRILL STST 2

Catalog Number	103.162
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following the incident, the patient was immediately referred for an endoscopic procedure.However, it was not possible to remove the drill from the patient's stomach during this procedure.Due to the positioning of the foreign object within the gastrointestinal tract, the multidisciplinary team opted to monitor its natural progression through the intestinal pathway via radiographic follow-up.Subsequently, the item was naturally expelled.The patient is in good general health.No medication administration or hospitalization was required to resolve the occurrence.Drills are rotary instruments indicated for the perforation of bone or dentin tissue during the preparation of the surgical site prior to implant placement.It is suggested that the swallowing of the item occurred due to improper handling by the student involved.As described in the product¿s ifu (instructions for use), inadequate surgical planning may compromise implant performance, resulting in system failure.During installation, the professional must ensure proper fit between the instrument and the contra-angle handpiece, and configure the surgical motor with appropriate drilling speed and torque for milling, as indicated for the selected implant.It is the professional¿s responsibility to verify the condition of the instruments, respect their usage time, and ensure that neodent products are used in accordance with the instructions provided for each application.Potential health risks to the patient arising from intraoperative swallowing of instruments may include, for example, injuries to the gastrointestinal tract.Such injuries may result in bleeding, perforations, and infiltration of specific microbiota into the interstitial space, which may require immediate medical intervention.It is concluded that the swallowing of the item resulted from improper handling by the user, as the drill was manually manipulated in disagreement with the guidelines established in the device¿s ifu.As also reported by the complainant, the patient was promptly referred for medical care following the incident, and therefore, the situation was resolved.There was no harm to the patient¿s health, no threat to public health, and no serious risk of injury to human health.The patient is well, and no surgical intervention was necessary.
Event or Problem Description
During a surgical implant placement procedure carried out in (b)(6) 2025, the item 103.162 ¿ twist drill was accidentally swallowed by the patient undergoing the procedure.While a student was manually checking the depth of the surgical site drilling, the drill fell into the patient's oral cavity and was quickly swallowed.

• Brand Name: TWIST DRILL STST 2
• Common Device Name: TWIST DRILL
• Manufacturer (Section D): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer (Section G): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; 9787472509
• MDR Report Key: 22905027
• Report Number: 3008261720-2025-003048
• Device Sequence Number: 8018489
• Product Code: DZA
• UDI-Device Identifier: 07898237561882
• UDI-Public: 07898237561882
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/25/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 103.162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/27/2025
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male