FDA Adverse Event Malfunction Summary report: N

THD SLIDE ONE

MDR report key: 9824264 · Received March 12, 2020

Report

Report Number: 3006680097-2020-00002
Event Type: Malfunction
Date Received: March 12, 2020
Date of Event: February 2, 2020
Report Date: March 12, 2020
Manufacturer: THD SPA
Product Code: JAF
PMA / PMN Number: K081429
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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 · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291161	THD SLIDE ONE	THD SLIDE ONE	JAF	THD SPA	710004	034019

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other