SYMMETRY SURGICAL INC.
Received Jun 28, 2024
Report 3007208013-2024-00031 · MDR key 19632995
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
RECEIVED VIA MEDWATCH REPORT# MW5154902. THE INFORMATION WAS RECEIVED THROUGH THE FDA WITH NO CUSTOMER INFORMATION PROVIDED. AS SUCH, NO INVESTIGATION CAN BE COMPLETED, CONFIRMATION OF THE COMPLAINT IS UNDETERMINABLE, AND A TRUE ROOT CAUSE CAN NOT BE ESTABLISHED. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.
Description of Event or Problem
THE COMPLAINANT ALLEGES, "DURING NEEDLE DRIVER INSPECTION TO ASSESS FOR INSTRUMENT INTEGRITY PRIOR TO USE, THE NEEDLE DRIVER TIP WAS DETECTED TO BE BENT WITH A SMALL PORTION OF IT THAT BROKE OFF. THE NEEDLE DRIVER WAS NEVER UTILIZED DURING THE CASE AND IT ALONG WITH THE BROKE TIP WERE SUBSEQUENTLY SEQUESTERED."