UNKNOWN JARIT
Received Jan 27, 2025 · Event occurred Dec 4, 2023
Report 3014334038-2025-00007 · MDR key 21242767
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
19 YR · Male
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
UPDATED FIELDS: G3, G6, H2, H3, H6, H11. THE UNKNOWN JARIT OSTEOTOME WAS NOT RETURNED FOR EVALUATION AS THE CUSTOMER INDICATED THAT THE DEVICE INVOLVED COULD NOT BE IDENTIFIED AND NO DEVICES WITH A MISSING TIP WERE FOUND. THUS, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE ISSUE OF AN OSTEOTOME BREAKING MAY BE THE RESULT OF ROUGH HANDLING OR ENVIRONMENTAL DAMAGE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE FULL NAME OF THE REPORTING FACILITY SUBSEQUENTLY PROVIDED BY THE CUSTOMER IS (B)(6) (SITE DIFFERS FROM ADDRESS POPULATED ON RELATED MEDSUN REPORT).
Description of Event or Problem
THE FOLLOWING WAS REPORTED VIA MEDSUN, UF/IMPORTER REPORT# (B)(4): "IT IS SUSPECTED THAT TIP OF CURVED OSTEOTOME BROKE OFF DURING SURGERY AND WAS RETAINED IN PATIENT'S NASAL CAVITY". IT WAS SUBSEQUENTLY REPORTED THAT AN UNSPECIFIED JARIT OSTEOTOME WAS USED DURING SEPTOPLASTY. "THE DEVICE WAS NOT WITNESSED TO BREAK INTRA-OPERATIVELY AND NO BROKEN INSTRUMENTS WERE NOTED IN THE SURGERY DEPARTMENT. THE METALLIC OBJECT WAS SHOWN IN POST-OPERATIVE IMAGING." "UNRELATED TO THE SURGERY, A COMPUTED TOMOGRAPHY (CT) OF SINUSES WAS TAKEN 6 MONTHS LATER ((B)(6)2023) WHICH SHOWED A NEW 5 MM RIGHT NASAL BONE METALLIC OPACITY." IT HAS NOT BEEN DETERMINED WHETHER THE PATIENT INCURRED ANY INJURY. THERE IS "STILL UNDERGOING EVALUATION TO DETERMINE WHAT THE RETAINED OBJECT IS." IT WAS REPORTED THAT THE PATIENT'S CONDITION IS STABLE. THE REPORTER WAS UNABLE TO PROVIDE A SPECIFIC PRODUCT ID OF THE SUSPECTED JARIT OSTEOTOME USED DURING THIS CASE, "SINCE NO BROKEN OSTEOTOMES WERE NOTED IN THE SURGERY CENTER"; THUS, THE SUSPECTED PRODUCT WILL NOT BE RETURNED FOR EVALUATION.