PRM STM INSRTR EXTRCT
Received Nov 30, 2022 · Event occurred Apr 4, 2022
Report 1038671-2022-01533 · MDR key 15885310
Device
Generic name
Orthopedic Manual Surgical Instrument
Manufacturer
Exactech, Inc.Model number
301-07-10Catalog number
301-07-10
Lot number
72726013
Product problems
- Break
- Break
Patient
Unknown
- 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 THIS INSTRUMENT COULD HAVE BROKEN DURING SURGERY. HOWEVER, THE BREAKAGE HAS BEEN NOTICED AT THE RECOVERY OF THE INSTRUMENTATION-SET BY OUR LOGISTICS DEPT., AFTER THE CLEANING REALIZED BY THE STERILIZATION TEAM OF THE HOSPITAL. NO INFORMATION HAS BEEN RECEIVED FROM THE HOSPITAL REGARDING THIS ISSUE AND XNOV IP DIDN'T RECEIVE ANY REQUEST FOR COMPLEMENTARY INFORMATION REGARDING THIS ISSUE AS WELL.
Additional Manufacturer Narrative
SECTION H10: (H3) THE MOSTLY LIKELY UNDERLYING CAUSE FOR THE BROKEN INSTRUMENT REPORTED CANNOT BE DETERMINED AS THE DEVICE APPEARS TO FUNCTION AS INTENDED. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 4755, PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE