CLASSIC PLUS NEEDLE HOLDER CRILE-WOOD, 6 IN
Received May 29, 2025
Report 3007208013-2025-00013 · MDR key 22107350
Device
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
COMPLAINANT ALLEGES "WE HAD AN ISSUE WITH ONE OF THE CRILEWOOD NEEDLE HOLDERS THAT WE JUST ORDERED. THE INSERT CHIPPED OFF WHILE THE SURGEON WAS USING IT."
Additional Manufacturer Narrative
THE ACTUAL DEVICE HAS BEEN RETURNED AND EVALUATED. THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative
THE ACTUAL DEVICES WERE RETURNED FOR EVALUATION. THEY WERE ONLY IN USE FOR A SHORT PERIOD OF TIME, AS THE CUSTOMER HAD THE PRODUCT LESS THAN A MONTH BEFORE THE INCIDENT OCCURRED. AT SOME POINT DURING EITHER TRANSIT, MATERIAL HANDLING, OR REPROCESSING, THE INSTRUMENTS MAY HAVE BEEN DROPPED WITH THE TIP-FIRST, LEADING TO STRUCTURAL DEFORMATION. THE IMPACT MAY HAVE COMPROMISED THE INTEGRITY OF THE PRODUCT, THEREBY CAUSING THE BREAKAGE OF THE TIP INSERTS. THE ROOT CAUSE IS TRANSIT DAMAGE. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.