FDA Adverse Event Malfunction Summary report: N

14 CM ANGLE ATTACHMENT

MDR report key: 4173579 · Received October 15, 2014

Report

Report Number: 1045834-2014-13911
Event Type: Malfunction
Date Received: October 15, 2014
Report Date: January 21, 2013
Manufacturer: DEPUY SYNTHES POWER TOOLS
Product Code: HBC
PMA / PMN Number: PK011444
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE DEVICE WAS DAMAGED. THIS WAS CONTRIBUTED TO IMPROPER MAINTENANCE OF THE DEVICE. VARIOUS PARTS WERE REPLACED. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

Description of Event or Problem · 1

DEVICE WAS SENT FOR REPAIR AS THE CUSTOMER FOUND IT WAS DIFFICULT TO ATTACH AND REMOVE THE CUTTING BURRS. IT OVERHEATED AND VIBRATES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
652965	14 CM ANGLE ATTACHMENT	MOTOR, DRILL, ELECTRIC	HBC	DEPUY SYNTHES POWER TOOLS

Patients

Seq	Age	Sex	Outcome	Treatment
1