CARPAL TUNNEL ECTR BLADE ASSEMBLY
Received Apr 12, 2021 · Event occurred Mar 18, 2021
Report 2134070-2021-00007 · MDR key 11649205
Device
Generic name
Orthopedic Manual Surgical Instrument
Manufacturer
Sterilmed, Inc.Model number
MIC81010Catalog number
MIC81010
Lot number
2093460
Product problems
- Break
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A REPROCESSED CARPAL TUNNEL ECTR BLADE ASSEMBLY AND THE ENDOSCOPIC BLADE BROKE INSIDE THE PATIENT. WE COULD NOT CONFIRM THE REPORTED ISSUE BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RECEIVED FOR EVALUATION AND COULD NOT BE VERIFIED AS BEING A STERILMED REPROCESSED DEVICE. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE VISUAL AND FUNCTIONAL INSPECTIONS COULD NOT BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED FOR THE FINISHED DEVICE LOT 2093460 AND NO NONCONFORMANCES WERE IDENTIFIED. MANUFACTURER'S REF. NO: (B)(4).
Additional Manufacturer Narrative
THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. MANUFACTURER'S REF. NO: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A REPROCESSED CARPAL TUNNEL ECTR BLADE ASSEMBLY AND THE ENDOSCOPIC BLADE BROKE INSIDE THE PATIENT. THERE WAS NO DIFFICULTY, PROCEDURAL OR PATIENT CIRCUMSTANCE IDENTIFIED BEFORE THE BREAK THAT CONTRIBUTED TO THE ISSUE REPORTED. THE FRAGMENTS WERE REMOVED FROM THE PATIENT. NO ADDITIONAL INTERVENTION WAS REQUIRED. HOWEVER, ADDITIONAL TIME WAS NEEDED AS THERE WAS SOME DIFFICULTY FINDING THE BROKEN PIECES INSIDE OF THE TISSUE.