MalfunctionGFG
LINVATEC DRILL
Received Aug 12, 2023
Report MW5140390 · MDR key 17533486
Device
Generic name
Bit, Surgical
Manufacturer
Linvatec CorporationProduct problems
- Component Missing
- Component Missing
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS NOTICED THAT WHILE THE SURGEON WAS REAMING THE FEMORAL HEAD THE TIP OF THE DRILL BIT WAS MISSING; IT WAS CAUGHT ON THE GUIDE WIRE AND EASILY RETRIEVED. A LINVATEC DRILL WAS BEING USED AT THE TIME OF THE EVENT. A TROCHANTERIC FIXATION NAIL ADVANCED SET WAS OPENED AND INSTRUMENTATION WAS REMOVED FROM THAT SET TO COMPLETE THE SURGERY. ROUTINE X-RAYS CONFIRMED THAT THERE WERE NO FRAGMENTS REMAINING IN THE PATIENT. THE FRACTURE WAS SUCCESSFULLY APPROXIMATED AND THE PATIENT'S STATUS WAS AS EXPECTED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).