CARPAL TUNNEL ECTR BLADE ASSEMBLY
Received Jul 5, 2022 · Event occurred Jun 1, 2022
Report 2134070-2022-00012 · MDR key 14920258
Device
Generic name
Orthopedic Manual Surgical Instrument
Manufacturer
Sterilmed, Inc.Model number
MIC81010Catalog number
MIC81010
Product problems
- Dull, Blunt
- Dull, Blunt
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH TWO REPROCESSED CARPAL TUNNEL ECTR BLADE ASSEMBLY AND THE BLADES WERE REPORTED TO BE DULL. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4). MANUFACTURE REPORT NUMBERS 2134070-2022-00011 ARE RELATED TO THE SAME EVENT.