OSTEOTOME 3714338 NEIVERT 4MM SGL GUARD
Received Nov 20, 2024 · Event occurred Oct 23, 2024
Report 3003249645-2024-00056 · MDR key 20742019
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT DURING RHINOPLASTY, THE TIP/END OF THE CHISEL/NEIVERT OSTEOTOME, 4MM SINGLE GUARDED (B)(6) BROKE OFF INSIDE THE BONE OF THE PATIENT. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. IT IS UNKNOWN WHETHER THE PART WAS REMOVED OR WHETHER A SURGICAL DELAY OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
THE OSTEOTOME NEIVERT 4MM SGL GUARD (3714338) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS: THE RETURNED 3714338 OSTEOTOME WAS IN USED CONDITION WITH THE BLADE CHIPPED. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. DAMAGE TO THE TIP MAY BE THE RESULT OF ROUGH HANDLING OR ENVIRONMENTAL DAMAGE. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.
Description of Event or Problem
N/A.