MDLR RVS RMR 46MM CNLTD
Received Sep 13, 2022 · Event occurred Aug 17, 2022
Report 1038671-2022-01096 · MDR key 15409929
Device
Generic name
Orthopedic Manual Surgical Instrument
Manufacturer
Exactech, Inc.Model number
321-35-46Catalog number
321-35-46
Lot number
133341008
Product problems
- Break
- Break
Patient
80 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PENDING EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT WHILE REAMING THE GLENOID, IT FRACTURED OFF THE SQUARE PIECE THAT ATTACHES TO THE TRI DRIVE. REP BELIEVES THE TECH DID NOT FULLY SEAT THE REAMER ON THE TRI DRIVE AND WHEN HE STARTED REAMING. NOTHING WAS DAMAGED ON THE PATIENTS END. NO FRAGMENTS, PARTS OR PIECES FELL INTO THE PATIENT. IT FRACTURED OUTSIDE THE 81 Y/O MALE PATIENT AND FROM THE TRI DRIVE CONNECTION PIECE MOST DISTAL. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS RETURNING.
Additional Manufacturer Narrative
(H3) THE BROKEN CANNULATED REAMER REPORTED MAY HAVE BEEN DUE TO INCOMPLETE SEATING OF THE REAMER ON THE TRI-DRIVER PRIOR TO USE, WHICH LED TO FRACTURING OF THE REAMER POST DURING REAMING. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 912, POST.