FDA Adverse Event Malfunction Summary report: N

LEGEND FOOTED ATTACHMENT

MDR report key: 2914504 · Received January 14, 2013

Report

Report Number: 1625507-2013-00004
Event Type: Malfunction
Date Received: January 14, 2013
Report Date: December 13, 2012
Manufacturer: MDT POWERED SURGICAL SOLUTIONS
Product Code: HBB
PMA / PMN Number: K020069
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

REPORT CONFIRMED. EVALUATION DETERMINED THAT THE FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. A PORTION OF THE FOOT OF THE ATTACHMENT WAS DETACHED AND MISSING. (B)(4) WAS INITIATED TO INVESTIGATE THIS MALFUNCTION. THE USER MANUAL CONTAINS THE FOLLOWING WARNING "THE ATTACHMENT SHOULD NOT BE USED IF ANY PART OF THE ATTACHMENT APPEARS TO BE BENT, LOOSE, MISSING, OR DAMAGED. EXCESSIVE PRESSURE OR IMPROPER HANDLING, SUCH AS BENDING OR PRYING, OF THE ATTACHMENT OR DISSECTING TOOL MAY CAUSE INJURY TO THE PATIENT, OPERATOR AND/OR OPERATING ROOM STAFF." THE PREVENTIVE MAINTENANCE/SERVICE MANUAL FOR THE LEGEND SYSTEM SPECIFIES SERVICE INTERVALS FOR DEVICES BASED ON THE HOSPITAL USAGE LEVEL. THE MAXIMUM SPECIFIED SERVICE INTERVAL IS 24 MONTHS. DEVICE HAS BEEN IN USE FOR APPROXIMATELY 32 MONTHS WITH NO RECORD OF FACTORY SERVICE DURING THIS PERIOD. WE WILL CONTINUE TO MONITOR THIS COMPLAINT TYPE FOR TRENDS. (B)(4).

Description of Event or Problem · 1

DEVICE RETURNED FOR REPAIR WITH NON-SPECIFIED REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO COMPLAINT ON DECONTAMINATION DUE TO ATTACHMENT FOOT BEING DAMAGED BY TOOL CONTACT. NO ADDITIONAL INFORMATION WAS AVAILABLE ON FOLLOW-UP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
20781	LEGEND FOOTED ATTACHMENT	MOTOR, DRILL, PNEUMATIC	HBB	MDT POWERED SURGICAL SOLUTIONS	N/A	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1