OXFORD 4MM DRILL
Received Dec 18, 2025 · Event occurred Dec 1, 2025
Report 3002806535-2025-00648 · MDR key 23835994
Device
Product problems
- Fracture
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS. THE PRODUCT INVOLVED IN THE REPORTED EVENT WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, THE PROVIDED PHOTOGRAPHS SHOW THAT THE DRILL FRACTURED INTO TWO PIECES AT THE MIDPOINT. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem
IT WAS REPORTED THAT A DURING THE PROCEDURE, A DRILL BIT FRACTURED WHILE CREATING THE FEMORAL DRILL HOLES. THE BROKEN FRAGMENT WAS SUCCESSFULLY RETRIEVED USING A CHUCK AND KEY. THIS RESULTED IN A BRIEF EXTENSION OF ANESTHESIA TIME AND AN APPROXIMATE 5-MINUTE PROCEDURAL DELAY. NO FURTHER IMPACT OR COMPLICATIONS TO THE PATIENT OR OPERATING STAFF WERE REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4) D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024578456. D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT LOT NUMBER IS UNKNOWN. G2: FOREIGN - EVENT OCCURRED IN NEW ZEALAND. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS EXEMPT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.