FIXT SUTURING DEVICE SINGLE
Received Mar 12, 2020
Report 1018233-2020-01773 · MDR key 9824319
Device
Product problems
- Biocompatibility
- Adverse Event Without Identified Device or Use Problem
- Biocompatibility
Patient
Not reported
- Foreign Body In Patient
- No Known Impact Or Consequence To Patient
- Foreign Body In Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THE USER POSSIBLY EXPERIENCED AN ISSUE WITH THE FIX SUTURE DEVICE. A SMALL BULLET END OF SUTURE EMBEDDED IN SACROSPINOUS LIGAMENT AND WAS LEFT IN-SITU.
Description of Event or Problem
IT WAS REPORTED THAT THE USER POSSIBLY EXPERIENCED AN ISSUE WITH THE FIXT SUTURE DEVICE. A SMALL BULLET END OF THE SUTURE WAS EMBEDDED IN THE SACROSPINOUS LIGAMENT AND WAS LEFT IN-SITU.
Additional Manufacturer Narrative
THE REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE OF THE REPORTED EVENT COULD BE "INADEQUATE DESIGN SELECTION (SHEAR FAILURE DUE TO TRANSVERSE LOADING)". THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. SINCE THE PRODUCT CATALOG NUMBER IS UNKNOWN, A LABELING REVIEW COULD NOT BE PERFORMED. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
Additional Manufacturer Narrative
THE REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE OF THE REPORTED EVENT COULD BE "INADEQUATE DESIGN SELECTION (SHEAR FAILURE DUE TO TRANSVERSE LOADING)". THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. SINCE THE PRODUCT CATALOG NUMBER IS UNKNOWN, A LABELING REVIEW COULD NOT BE PERFORMED. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THE USER POSSIBLY EXPERIENCED AN ISSUE WITH THE FIXT SUTURE DEVICE. A SMALL BULLET END OF THE SUTURE WAS EMBEDDED IN THE SACROSPINOUS LIGAMENT AND WAS LEFT IN-SITU.