MalfunctionHTN
ACU-SINCH® KIT
Received Oct 15, 2025 · Event occurred Sep 17, 2025
Report 3025141-2025-00490 · MDR key 23281032
Device
Generic name
Washer, Bolt Nut
Manufacturer
Acumed, LlcModel number
46-0001-SCatalog number
46-0001-S
Lot number
646989
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SURGEON RELEASED THE SUTURES FROM THE HANDLE AND AT THAT MOMENT THE SUTURES CAME LOOSE OF THE SCREW. HE COULD NOT REATTACH THE SUTURES TO THE ANCHOR. THERE WAS A DELAY OF 30 MINUTES.
Additional Manufacturer Narrative
TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE.