STEEL
Received Mar 31, 2025 · Event occurred Mar 10, 2025
Report 9612501-2025-00899 · MDR key 21735909
Device
Generic name
Suture, Nonabsorbable, Steel, Monofilament And
Manufacturer
Davis & Geck Caribe LtdModel number
88862410-89Catalog number
88862410-89
Lot number
D4H1824Y
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D10 CONCOMITANT MEDICAL PRODUCT: 88862410-89, 88862410-89 STEEL5 4X45CM HOS14 ROTOGRIP (LOT# D4B3977Y) 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
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, DURING CHEST CLOSURE, WHILE THE SURGEON WAS PUTTING ON THE 3RD STERNAL WIRE OF A SET OF 4 PER PACK, THE NEEDLE CAME OFF FROM THE WIRE WHEN PULLED. A NEW SUTURE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.