MAUDE Adverse Event Report: JJGC S.A. MANUAL SCREWDRIVER (MEDIUM) STST 0.9; SURGICAL SCREWDRIVER, REUSABLE

Model Number	104.041
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	09/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the surgery the dentist did not follow the ifu instruction: "before using this product, it is recommended to tie a safety thread in the hole to avoid any movement or the risk of it being swallowed or inhaled by the patient." this way, the screwdriver has dislocated and was swallowed by the patient.The patient was submitted to a colonoscopy to remove the screwdriver of their intestine.The patient did not present any symptom and is doing well and stable, there are no furthers information about the case.The event did not brought damages to the patient¿s health, but if recurs there is potential to cause injuries.

• Brand Name: MANUAL SCREWDRIVER (MEDIUM) STST 0.9
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• 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: 16384278
• Report Number: 3008261720-2022-14828
• Device Sequence Number: 20238575
• Product Code: LRZ
• UDI-Device Identifier: 07898237563619
• UDI-Public: 07898237563619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

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 Model Number: 104.041
• Device Catalogue Number: 104.041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/16/2023
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2023
• 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