CARBIDE BUR FG 665760 USA 700XXL
Report
- Report Number
- 2515379-2025-00022
- Event Type
- Injury
- Date Received
- September 30, 2025
- Date of Event
- September 29, 2025
- Report Date
- December 17, 2025
- Manufacturer
- DENTSPLY LLC
- Product Code
- EJL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
INVESTIGATION RESULTS: DHR - ONLY TWO UNUSED BURS WERE RETURNED, STILL FACTORY SEALED IN BLISTERS. INVOLVED INSTRUMENTS USED BY THE CUSTOMER AND THAT DIDN'T GIVE SATISFACTION WERE NOT RETURNED. PER DRAWING (B)(4), THE ISSUE IS WITH THE SHANK DIAMETER D4 - Ø1.6 [0; -0.01] MM. THE SHANK PORTION OF THE UNUSED BURS WAS TESTED WITH A RING GAUGE NO GO Ø1.59MM (#4282). RESULT IS PASS, THE TWO SHANKS DON'T FIT THROUGH NO GO GAUGE. SHANKS ARE NOT UNDERSIZED. NO FAULT WAS FOUND WITH THESE INSTRUMENTS. FOR INFORMATION, THE BURS WERE CONNECTED TO THE CUSTOMER'S HANDPIECE. THE INSTRUMENTS FIT IN THE CARTRIDGE WITHOUT DIFFICULTY, AND FIRMLY HOLD INSIDE ONCE THEIR SHANK IS FULLY INSERTED. FUNCTIONAL TEST IS PASS. THE ROOT CAUSES OF LATCHING ISSUES EXPERIENCED BY THE CUSTOMER ARE NOT IDENTIFIED, NOTABLY BECAUSE THE BURS USED BY THE CUSTOMER ARE NOT AVAILABLE FOR FUNCTIONAL TEST AND MEASUREMENTS. FOR INFORMATION, PLEASE NOTE THAT: THE BATCH NUMBER IS KNOWN, DHR IS AVAILABLE. 297 BLISTER PACKS WERE PREPARED THROUGH THIS BATCH RELEASED ON (B)(6) 2023, AND WHICH WAS SENT IN FOUR PARCELS TO DENTSPLY NORTH AMERICA LLC ON (B)(6) 2023. NO MORE PART FROM THIS BATCH IS IN INVENTORY TO DATE. THE BURS WHICH WERE USED FOR THE NEEDS OF THE PACKAGING BATCH #1813829 CAME FROM THE TWO DIFFERENT WIP LOTS #1783191 (17 INSTRUMENTS) AND #1802517 (2983 INSTRUMENTS). WE FOUND DURING DHR REVIEW THE FOLLOWING NONCONFORMING MATERIAL REPORTS: -QH #(B)(4) (WIP LOT #1783191), ISSUED DURING BRAZED SST SHANK TURNING OPERATION FOR COUNTING DIFFERENCE (DEFECT CODE D3). THE PRODUCTION WAS SORTED. NO RELATION WITH THE SUBJECT OF THE COMPLAINT. -QH #(B)(4) (WIP LOT #1802517), ISSUED DURING BRAZED SST SHANK TURNING OPERATION FOR COUNTING DIFFERENCE. THE PRODUCTION WAS SORTED. NO RELATION WITH THE SUBJECT OF THE COMPLAINT. D4 DIMENSION IS GET BY INTERNAL GRINDING. MANUFACTURING RECORDS ARE AVAILABLE AND SHOW THAT THE DIMENSION WAS REGULARLY CHECKED DURING GRINDING OPERATIONS AND REPORTED: -PRODUCTION WIP LOT #1783191: 6X 3 PARTS WERE TAKEN AND MEASURED, FINDINGS WERE BETWEEN 1.952 AND 1.954MM (WITHIN SPECIFICATIONS). MOREOVER, D4 DIMENSION WAS STATISTICALLY CHECKED BY GAUGING BY DIMENSIONAL INSPECTION TEAM BEFORE PRODUCTION RELEASE. THREE PARTS WERE TESTED AND FOUND IN COMPLIANCE. -PRODUCTION WIP LOT #1802517: 4X 3 PARTS WERE TAKEN AND MEASURED, FINDINGS WERE BETWEEN 1.952 AND 1.954MM (WITHIN SPECIFICATIONS). MOREOVER, D4 DIMENSION WAS STATISTICALLY CHECKED BY GAUGING BY DIMENSIONAL INSPECTION TEAM BEFORE PRODUCTION RELEASE. THREE PARTS WERE TESTED AND FOUND IN COMPLIANCE. THIS IS THE FIRST COMPLAINT RECEIVED INVOLVING THIS BATCH NUMBER FOR THIS ISSUE. THIS PRODUCTION WAS MADE UNDER THE FOLLOWING PROCESS DEVIATIONS: -SI 965, ISSUED TO STATE THE IMPLEMENTATION OF NEW PRINTING MACHINES SATO IDENTICAL TO THE ONES ALREADY IN USE. NO RELATION WITH THE SUBJECT OF THE COMPLAINT. -SI 984, ISSUED TO STATE THE IMPLEMENTATION OF NEW PRINTING MACHINES SATO IDENTICAL TO THE ONES ALREADY IN USE. NO RELATION WITH THE SUBJECT OF THE COMPLAINT. -SI 989, ISSUED TO STATE THE IMPLEMENTATION OF NEW PRINTING MACHINES SATO IDENTICAL TO THE ONES ALREADY IN USE. NO RELATION WITH THE SUBJECT OF THE COMPLAINT. PRODUCTION BATCH #1858616. PRODUCTS WERE RECEIVED ON (B)(6) 2025. UNUSED BURS BATCH #1813829 (2 ITEMS), BATCH #1858616 (2 ITEMS) AND BATCH #1891885 (5 ITEMS) WERE RETURNED. A HANDPIECE BELONGING TO THE CUSTOMER WAS ALSO PROVIDED (BEYES MAXSO 200-45/M4 HANDPIECE). THIS INVESTIGATION IS FOR PRODUCTION BATCH #1858616. ONLY TWO UNUSED BURS WERE RETURNED, STILL FACTORY SEALED IN BLISTERS. INVOLVED INSTRUMENTS WHICH WERE USED BY THE CUSTOMER AND THAT DIDN'T GIVE SATISFACTION WERE NOT RETURNED. PER DRAWING (B)(4), THE ISSUE IS WITH THE SHANK DIAMETER D4 - Ø1. 6[0; -0.01] MM. THE SHANK PORTION OF THE UNUSED BURS WAS TESTED WITH A RING GAUGE NO GO Ø1.59MM (#4282). RESULT IS PASS, THE TWO SHANKS DON'T FIT THROUGH NO GO GAUGE. SHANKS ARE NOT UNDERSIZED. NO FAULT WAS FOUND WITH THESE INSTRUMENTS. FOR INFORMATION, THE BURS WERE CONNECTED TO THE CUSTOMER'S HANDPIECE. THE INSTRUMENTS FIT IN THE CARTRIDGE WITHOUT DIFFICULTY, AND FIRMLY HOLD INSIDE ONCE THEIR SHANK IS FULLY INSERTED. FUNCTIONAL TEST IS PASS. THE ROOT CAUSES OF LATCHING ISSUES EXPERIENCED BY THE CUSTOMER ARE NOT IDENTIFIED, NOTABLY BECAUSE THE BURS USED BY THE CUSTOMER ARE NOT AVAILABLE FOR FUNCTIONAL TEST AND MEASUREMENTS. FOR INFORMATION, PLEASE NOT THAT: THE BATCH NUMBER IS KNOWN, DHR IS AVAILABLE. 307 BLISTER PACKS WERE PREPARED THROUGH THIS BATCH RELEASED ON (B)(6) 2024, AND WHICH WAS SENT IN TWO PARCELS TO DENTSPLY NORTH AMERICA LLC ON (B)(6) 2024. NO MORE PART FROM THIS BATCH IS IN INVENTORY TO DATE. THE BURS WHICH WERE USED FOR THE NEEDS OF THE PACKAGING BATCH #1858616 CAME FROM THE WIP LOT #1846424 (3100 INSTRUMENTS). NO RELEVANT INFORMATION WAS FOUND DURING DHR REVIEW (NO NONCONFORMING MATERIAL REPORT WAS ISSUED DURING MANUFACTURING OR PACKAGING PROCESSES). D4 DIMENSION IS GET BY INTERNAL GRINDING. MANUFACTURING RECORDS ARE AVAILABLE AND SHOW THAT THE DIMENSION WAS REGULARLY CHECKED DURING GRINDING OPERATIONS AND REPORTED. 4X 3 PARTS WERE TAKEN AND MEASURED, FINDINGS WERE BETWEEN 1.951 AND 1.955MM (WITHIN SPECIFICATIONS). MOREOVER, D4 DIMENSION WAS STATISTICALLY CHECKED BY GAUGING BY DIMENSIONAL INSPECTION TEAM BEFORE PRODUCTION RELEASE. THREE PARTS WERE TESTED AND FOUND IN COMPLIANCE. THIS IS THE FIRST COMPLAINT RECEIVED INVOLVING THIS BATCH NUMBER FOR THIS ISSUE. PRODUCTION BATCH #1891885 PRODUCTS WERE RECEIVED ON (B)(6) 2025. UNUSED BURS BATCH #1813829 (2 ITEMS), BATCH #1858616 (2 ITEMS) AND BATCH #1891885 (5 ITEMS) WERE RETURNED. A HANDPIECE BELONGING TO THE CUSTOMER WAS ALSO PROVIDED (BEYES MAXSO 200-45/M4 HANDPIECE). THIS INVESTIGATION IS FOR PRODUCTION BATCH #1891885. ONLY FIVE UNUSED BURS WERE RETURNED, STILL FACTORY SEALED IN BLISTERS. INVOLVED INSTRUMENTS USED BY THE CUSTOMER AND THAT DIDN'T GIVE SATISFACTION WERE NOT RETURNED. PER DRAWING 2234_0008_00 REV.02, THE ISSUE IS WITH THE SHANK DIAMETER D4 - Ø1.6[0;-0.01]MM. THE SHANK PORTION OF THE UNUSED BURS WAS TESTED WITH A RING GAUGE NO GO Ø1.59MM (#4282). RESULT IS PASS, THE FIVE SHANKS DON'T FIT THROUGH NO GO GAUGE. SHANKS ARE NOT UNDERSIZED. NO FAULT WAS FOUND WITH THESE INSTRUMENTS. FOR INFORMATION, THE BURS WERE CONNECTED TO THE CUSTOMER'S HANDPIECE. THE INSTRUMENTS FIT IN THE CARTRIDGE WITHOUT DIFFICULTY, AND FIRMLY HOLD INSIDE ONCE THEIR SHANK IS FULLY INSERTED. FUNCTIONAL TEST IS PASS. THE ROOT CAUSES OF LATCHING ISSUES EXPERIENCED BY THE CUSTOMER ARE NOT IDENTIFIED, NOTABLY BECAUSE THE BURS USED BY THE CUSTOMER ARE NOT AVAILABLE FOR FUNCTIONAL TEST AND MEASUREMENTS. FOR INFORMATION, PLEASE NOT THAT: THE BATCH NUMBER IS KNOWN, DHR IS AVAILABLE. 447 BLISTER PACKS WERE PREPARED THROUGH THIS BATCH RELEASED ON (B)(6) 2024, AND WHICH WAS SENT IN TWO PARCELS TO DENTSPLY NORTH AMERICA LLC ON (B)(6) 2024. NO MORE PART FROM THIS BATCH IS IN INVENTORY TO DATE. THE BURS WHICH WERE USED FOR THE NEEDS OF THE PACKAGING BATCH #1891885 CAME FROM THE TWO DIFFERENT WIP LOTS #1862044 (369 INSTRUMENTS) AND #1874714 (4101 INSTRUMENTS). NO RELEVANT INFORMATION WAS FOUND DURING DHR REVIEW (NO NONCONFORMING MATERIAL REPORT WAS ISSUED DURING MANUFACTURING OR PACKAGING PROCESSES). D4 DIMENSION IS GET BY INTERNAL GRINDING. MANUFACTURING RECORDS ARE AVAILABLE AND SHOW THAT THE DIMENSION WAS REGULARLY CHECKED DURING GRINDING OPERATIONS AND REPORTED: -PRODUCTION WIP LOT #1862044: 5X 3 PARTS WERE TAKEN AND MEASURED, FINDINGS WERE ALL AT 1.952MM (WITHIN SPECIFICATIONS). MOREOVER, D4 DIMENSION WAS STATISTICALLY CHECKED BY GAUGING BY DIMENSIONAL INSPECTION TEAM BEFORE PRODUCTION RELEASE. THREE PARTS WERE TESTED AND FOUND IN COMPLIANCE. -PRODUCTION WIP LOT #1874714: 4X 3 PARTS WERE TAKEN AND MEASURED, FINDINGS WERE BETWEEN 1.953 AND 1.955MM (WITHIN SPECIFICATIONS). MOREOVER, D4 DIMENSION WAS STATISTICALLY CHECKED BY GAUGING BY DIMENSIONAL INSPECTION TEAM BEFORE PRODUCTION RELEASE. THREE PARTS WERE TESTED AND FOUND IN COMPLIANCE. THIS IS THE FIRST COMPLAINT RECEIVED INVOLVING THIS BATCH NUMBER FOR THIS ISSUE. THIS PRODUCTION WAS MADE UNDER THE FOLLOWING PROCESS DEVIATIONS: -SI 991, ISSUED TO STATE THE MOVING OF THE PACKING MACHINES RPOS AND RPC IN ZEC ROOM. NO RELATION WITH THE SUBJECT OF THE COMPLAINT. -SI 1012, ISSUED TO STATE AN ISSUE WHICH OCCURS DURING PRINTINGS OF THE LABELS. A TEMPORARY SOLUTION WAS BROUGHT BY IT SERVICE. NO RELATION WITH THE SUBJECT OF THE COMPLAINT. -SI 1030, ISSUED TO TRACE THE PRODUCTIONS DEGREASED WITH A SOLVENT TOO ACID, UNTIL THE SOLVENT HAS STABILIZED. NO RELATION WITH THE SUBJECT OF THE COMPLAINT. -SI 1041, ISSUED TO STATE THE USE OF THE NEW PRINTING MACHINE ZEBRA ZT411 STILL IN PENDING VALIDATION (TESTS ALREADY DONE SHOWED THAT PRINTING WAS CONFORMING). NO RELATION WITH THE SUBJECT OF THE COMPLAINT.
IN THIS EVENT IT IS REPORTED THAT A CARBIDE BUR FG 665760 USA 700XXL ALLEGEDLY UNLATCHED FROM THE HANDPIECE DURING USE AND RESULTED IN THE BUR LODGING IN THE PATIENT'S SINUS. PATIENT WAS SEEN BY AN ORAL SURGEON TO REMOVE THE BUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2153995 | CARBIDE BUR FG 665760 USA 700XXL | BUR, DENTAL | EJL | DENTSPLY LLC | 1813829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |