STEEL
Received May 27, 2026 · Event occurred Apr 28, 2026
Report 9612501-2026-01458 · MDR key 25297791
Device
Generic name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Manufacturer
Davis & Geck Caribe LtdModel number
88862392-49Catalog number
88862392-49
Lot number
D5C4694Y
Product problems
- Detachment of Device or Device Component
Patient
Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D10 CONCOMITANT PRODUCTS: 88862392-49, 88862392-49 STEEL 7 2X45CM KV40 X12 (LOT#:D5C4694Y) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE DETACHED WHILE SUTURING OR PREPARING SUTURE AFTER PATIENT INCISION. MORE THAN ONE DEVICE WAS INVOLVED IN THE EVENT, AND AN ADDITIONAL SUTURE FROM ANOTHER MANUFACTURER WAS USED WITHOUT ISSUE. IT WAS REPORTED THAT ONE PERSON WAS INJURED.