FDA Adverse Event Injury Summary report: N

SCREW, FIXATION, BONE

MDR report key: 3781645 · Received April 30, 2014

Report

Report Number: 2520274-2014-11118
Event Type: Injury
Date Received: April 30, 2014
Report Date: April 1, 2014
Manufacturer: SYNTHES (USA)
Product Code: HWC
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS DEVICE BELONGS TO PRODUCT FAMILY 04.005.5XX. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 3 LOCKING SCREWS WITH UNKNOWN PART AND LOT NUMBERS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A HARDWARE REMOVAL DUE TO A NONUNION/ MALUNION OF THE DISTAL FEMUR. THE PATIENT FRACTURED HER FEMUR ON (B)(6) 2013 AND ON (B)(6) 2013 THE FRACTURE WAS TREATED WITH A TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL. THE PATIENT RETURNED TO THE OPERATING ROOM FOR A HARDWARE REMOVAL AND CORRECTION OF ALIGNMENT WITH A 4.5 VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE. THERE WAS NO REPORTED DELAY IN THE PROCEDURE OR PATIENT HARM. THIS REPORT IS FOR 3 LOCKING SCREWS WITH UNKNOWN PART AND LOT NUMBERS THIS IS REPORT 2 OF 4 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
259785		SCREW, FIXATION, BONE	HWC	SYNTHES (USA)

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention