LAG SCREW DRILL
Received Jun 30, 2025 · Event occurred Jun 7, 2025
Report 0001825034-2025-01910 · MDR key 22357116
Device
Generic name
Fluted Surgical Drill Bit, Reusable
Manufacturer
Zimmer Biomet, Inc.Model number
NICatalog number
211201303
Lot number
SO2000511
Product problems
- Fracture
- Difficult to Insert
- Fracture
- Difficult to Insert
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE LAG SCREW DRILL GOT CAUGHT ON THE AFFIXUS ROD AND THE TIP OF THE LAG DRILL BROKE OFF DURING DRILLING FOR THE LAG SCREW. THE BROKEN PIECE WAS IMMEDIATELY REMOVED WITH THE GUIDE WIRE AND DISPOSED OF IN THE SHARPS CONTAINER. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). D10: ITEM# UNK AFFIXUS ROD; LOT# UNKNOWN. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - DRILL. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6 D10: ITEM# UNK NAIL; LOT# UNKNOWN. ITEM# UNK TARGETING GUIDE; LOT# UNKNOWN. ITEM# UNK AFFIXUS ROD; LOT# UNKNOWN. VISUAL EXAMINATION OF THE RETURNED DRILL PRODUCT IDENTIFIED SIGNS OF USE WITH SOME WEAR AND TEAR ON THE PROXIMAL END OF THE REAMER AS WELL AS SOME DAMAGE TO THE CONNECTING FEATURE. THERE IS ALSO SOME GALLING ON THE SHAFT OF THE REAMER AND DAMAGE TO THE CUTTING FLUTES. THE REAMER HAS FRACTURED AT THE DISTAL END, AND THE BROKEN PIECE WAS NOT RETURNED WITH THE REST OF THE DEVICE. SHAFT DIAMETER WAS MEASURED AND CONFORMING TO SPECIFICATIONS. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT WAS CONFIRMED. IF ANY FURTHER INFORMATION 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.