FDA Adverse Event Malfunction Summary report: N

CAD II

MDR report key: 6367823 · Received March 1, 2017

Report

Report Number: 8030965-2017-11001
Event Type: Malfunction
Date Received: March 1, 2017
Report Date: February 6, 2017
Manufacturer: DEPUY SYNTHES POWER TOOLS
Product Code: HWE
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: (B)(4). (B)(6). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER HANDLING, WHICH IS USER ERROR/MISUSE/ABUSE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

Description of Event or Problem · 1

IT WAS REPORTED FROM (B)(6) THAT THE COMPACT AIR DRIVE DEVICE COUPLING POWER SUPPLY WAS DEFORMED AND BENT. DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE DEVICE FAILED PRE-TEST FOR STATUS OF DEVELOPMENT, GENERAL CONDITION, AIR HOSE COUPLING, AIR LEAK AND FUNCTION OF SOFT MODE SWITCH (SAFETY SYSTEM). IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SCHEDULED SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
152361	CAD II	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT	HWE	DEPUY SYNTHES POWER TOOLS		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1