STANDARD NEEDLES 27GA LONG

Additional Manufacturer Narrative

REPROCESSED: UNK.

Description of Event or Problem

MFR REPORT#: US-SEPTODONT: (B)(4). #1: DEVICE FRAGMENT EMBEDDED V29.0 (WHEN THEY WERE UNABLE TO FIND THE BROKEN TIP): FROM ON (B)(6) 2026 10:15 - SERIOUS - UNKNOWN. #2: NEEDLE BROKEN V29.0 (BROKEN TIP): FROM ON (B)(6) 2026 10:15 - NOT SERIOUS - UNKNOWN. SPONTANEOUS REPORT FROM THE UNITED STATES. LOCAL REFERENCE: US-SEPTODONT - (B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES#: (B)(4). THIS INITIAL NON-SERIOUS CASE REPORT WAS RECEIVED ON 10-JUL-2026 FROM THE DENTIST VIA DISTRIBUTOR BY EMAIL. FOLLOW-UP #1 WAS RECEIVED ON 14-JUL-2026 FROM THE DENTIST VIA DISTRIBUTOR BY EMAIL. FOLLOW-UP #2 WAS RECEIVED ON 15-JUL-2026 FROM THE DENTAL CLINIC BY PHONE. ALL THE INFORMATION WAS PROCESSED TOGETHER. INCIDENT DESCRIPTION NARRATIVE: THE REPORT DESCRIBED A NEEDLE BROKEN AND DEVICE FRAGMENT EMBEDDED WITH THE SUSPECTED MEDICAL DEVICE HENRY SCHEIN STANDARD NEEDLES 27GA LONG PRIOR TO MULTIPLE FILLINGS ON #4, 5, 29, 30, 31 UPPER RIGHT (UR) AND LOWER RIGHT (LR). THIS CASE OCCURRED ON A 24-YEAR-OLD FEMALE PATIENT. THE PATIENT WAS NOT ANXIOUS. NO ADDITIONAL INFORMATION WAS AVAILABLE ON THE PATIENT. ON (B)(6) 2026 AT APPROXIMATELY 10:15, IT WAS REPORTED THAT THE DOCTOR WAS USING THE NEEDLE TO INJECT ANESTHETIC DURING AN UPPER MIDDLE SUPERIOR ALVEOLAR (MSA) INJECTION PRIOR TO THE INFERIOR ALVEOLAR (IA) INJECTION. DURING THE IA INJECTION, THE DOCTOR HAD TO REPOSITION THE NEEDLE BUT NOTHING THAT CAUSED THE SEPARATION. THE NEEDLE BROKE AT THE HUB, AT RIGHT CHEEK DURING IA BLOCK AND GOT LODGED IN THE PATIENT'S SOFT TISSUE. THE DENTIST HAD SCREWED IN THE NEEDLE PROPERLY IN THE SYRINGE. THERE WAS NO SUDDEN MOVEMENT BY PATIENT, NO RESISTANCE, NO EXTREME PRESSURE AND THE NEEDLE WAS NOT BENT BEFORE INJECTION. CORRECTIVE TREATMENT: WHEN THEY WERE UNABLE TO FIND THE BROKEN TIP, THE PATIENT WAS THEN SENT TO THE EMERGENCY ROOM (ER). THERE WAS NOTHING OUT OF THE ORDINARY DURING THE INJECTION. ACCORDING TO THE OFFICE, SURGERY WAS FINE. THE PATIENT GOT OUT OF THE SURGERY AFTER 1 HOUR, WHICH WOULD HAVE USUALLY TAKEN 20 MINUTES. THE PATIENT WAS DISCHARGED FROM ER APPROXIMATELY 08:30 ON (B)(6) 2026. AS PER ON (B)(6) 2026 FOLLOW-UP BY THE CLINIC, THE PATIENT WAS ABLE TO GO BACK TO WORK ON (B)(6) 2026, MONDAY. OTHER INFORMATION OF PRODUCT: HENRY SCHEIN STANDARD NEEDLES 27GA LONG, BATCH NUMBER: #F14324AA, EXPIRY DATE: 05-FEB-2030. CONCOMITANT MEDICATION: SEPTOCAINE 1:100K (ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTARATE) (BATCH: UNKNOWN, EXPIRY: UNKNOWN) 2 CARTRIDGES. OUTCOME: AT THE TIME OF THE REPORT, THE PATIENT'S OUTCOME WAS UNKNOWN. NO OTHER INFORMATION AVAILABLE. THIS CASE WAS CONSIDERED AS SERIOUS DUE TO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). MANUFACTURER'S PRELIMINARY COMMENTS: FOR INITIAL AND FOLLOW-UP REPORTS: PRELIMINARY RESULTS AND CONCLUSIONS OF MANUFACTURER'S INVESTIGATION: BASED ON FIRST AVAILABLE INFORMATION, THIS REPORT DESCRIBED A NEEDLE BROKEN AND DEVICE FRAGMENT EMBEDDED WITH THE SUSPECTED MEDICAL DEVICE HENRY SCHEIN STANDARD NEEDLES 27GA LONG PRIOR TO MULTIPLE FILLINGS. DURING THE INFERIOR ALVEOLAR INJECTION, THE DOCTOR HAD TO REPOSITION THE NEEDLE BUT NOTHING THAT CAUSED THE SEPARATION. THE NEEDLE BROKE AT THE HUB, AT RIGHT CHEEK DURING IA BLOCK AND GOT LODGED IN THE PATIENT'S SOFT TISSUE. CAUSES OF NEEDLE BREAKAGE MAY INCLUDE BENDING OF NEEDLE PRIOR USE, INSERTION UP TO THE HUB, EXCESSIVE PRESSURE OR MOVEMENT OF THE NEEDLE DURING INJECTION, A SUDDEN MOVEMENT OF THE PATIENT DURING INJECTION AND/OR THE USE OF A NEEDLE SIZE INAPPROPRIATE TO THE TYPE OF PROCEDURE, OR THE USE OF THE NEEDLE IN SPITE OF AN OBSTACLE (E.G BONE). HOWEVER, IT WAS REPORTED THAT THE DENTIST HAD SCREWED IN THE NEEDLE PROPERLY IN THE SYRINGE. THERE WAS NO SUDDEN MOVEMENT BY PATIENT, NO RESISTANCE, NO EXTREME PRESSURE AND THE NEEDLE WAS NOT BENT BEFORE INJECTION. ACCORDING TO THE INFORMATION REPORTED, QUALITY DEFECT CANNOT BE EXCLUDED AND PENDING QIR, NO PROPER ASSESSMENT CAN BE DONE. USE ERROR/ABNORMAL USE NOT EXCLUDED. INITIAL ACTIONS (CORRECTIVE AND/OR PREVENTIVE) IMPLEMENTED BY THE MANUFACTURER: BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED.