TC TENOTOMY SCISSDELCVD1/SERR130MM
Received Aug 11, 2022 · Event occurred Jul 13, 2022
Report 2916714-2022-00087 · MDR key 15214566
Device
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED TO AESCULAP INC. THAT A TC TENOTOMY SCISSDELCVD1/SERR130MM (PART # DO250R) WAS USED DURING A TOTAL SHOULDER REPLACEMENT SURGERY PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SCISSOR BROKE WHILE CUTTING SOFT TISSUE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. AN X-RAY WAS TAKEN INTRAOPERATIVELY; THERE WAS A DELAY OF 10-15 MINUTES. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Description of Event or Problem
INVESTIGATION COMPLETE.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS NO LOT NUMBER WAS MADE AVAILABLE. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.