THD SLIDE ONE
Received Mar 12, 2020 · Event occurred Feb 2, 2020
Report 3006680097-2020-00002 · MDR key 9824264
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DISPOSABLE NEEDLE HOLDER, TO DATE, IS NOT AVAILABLE TO PERFORM A TECHNICAL INVESTIGATION SINCE IT IS NOT YET RETURNED TO THD SPA. BASING ON THE DESCRIPTION OF THE EVENT, THE BREAKAGE IS COMPATIBLE WITH A DEFORMATION BREAK DUE TO A NON-UNIFORMITY OF THE WELD (I.E. INCLUSIONS, VACUUM, CRACK, COLD WELD, ETC). THE INVESTIGATION OF THE COMPLAINT WITH REFERENCE TO THE MANUFACTURING RECORDS FOUND THAT THE SUBJECT DEVICE WAS RELEASED CONFORM FOR DISTRIBUTION AND NO ANOMALIES WERE FOUND. COMPLAINTS TREND ANALYSIS DID NOT FOUND ANY SIMILAR EVENTS ON THE SAME DEVICE ON OVER (B)(4) DEVICES SOLD OVER YEARS. WE THEREFORE CONSIDER THE EVENT AS A RARE AND ISOLATED PROBLEM COMPATIBLE WITH A MANUFACTURING DEFECT RELATED TO WELDING NOT DETECTABLE DURING INCOMING CONTROLS. THE MONITORING ACTIVITY ON NEW DEVICES IS CARRIED OUT ROUTINELY. SHOULD WE GET FURTHER INFORMATION, ADDITIONAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
DURING A T.H.D. INTERVENTION, THE DISPOSABLE NEEDLE HOLDER, PART OF THE THD SLIDE ONE KIT (REF. (B)(4)), BROKE. THE BROKEN PIECE HAS BEEN RETRIEVED BY THE SURGEON WITHOUT ANY CONSEQUENCE FOR THE PATIENT.