STEEL
Received Nov 8, 2024
Report 9612501-2024-02852 · MDR key 20646151
Device
Generic name
Suture, Nonabsorbable, Steel, Monofilament And
Manufacturer
Davis & Geck Caribe LtdModel number
88862424-89Catalog number
88862424-89
Lot number
D3H3320Y
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 PRODUCTS: 88862424-89 - 88862424-89 STEEL5 2X75CM HOS14 ROTOGRIP, LOT# D3H3320Y. 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, DURING A PROCEDURE, THE NEEDLE CAME OFF FROM THE STERNAL WIRE AS THE SURGEON WAS USING IT ON STERNUM AS A 2ND BITE. SAME HAPPENED WITH THE 2ND NEEDLE FROM SAME PACKET. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.