FDA Adverse Event Malfunction Summary report: N

CURVTEK CARTRIDGE 7MM MEDIUM

MDR report key: 1905049 · Received November 22, 2010

Report

Report Number: 1825034-2010-00618
Event Type: Malfunction
Date Received: November 22, 2010
Date of Event: October 20, 2010
Report Date: October 28, 2010
Manufacturer: BIOMET SPORTS MEDICINE
Product Code: HSZ
PMA / PMN Number: K972860
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: WARNING #1 - DO NOT APPLY EXCESSIVE PRESSURE ON THE TRIGGER MECHANISM WHILE DRILLING. FRACTURE OF THE GUIDE ARM OR DRILL ASSEMBLY IS POSSIBLE. EVALUATION OF THE RETURNED DEVICE FOUND A GROOVE IN THE EDGE AND FRACTURED STRANDS OF THE FLEXIBLE SHAFT WIRE ENDS TO BE TWISTED BACKWARD. THAT TYPE OF TWISTING SUGGESTS THE CUTTING TIP MAY HAVE BEEN SUDDENLY RESTRAINED IN SOME WAY. THE GROOVE MAY INDICATE A NONLINEAR INTERACTION OF THE ARM WITH A HARD SURFACE SUCH AS BONE CONSISTENT WITH UNSTABLE POSITIONING OF THE INSTRUMENT. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2010. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT FILED NOVEMBER 22, 2010.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A BONE TUNNELING DEVICE ON (B)(6) 2010. DURING THE PROCEDURE, THE TIP OF THE DEVICE FRACTURED AS IT WAS BEING USED. IT IS NOT KNOWN IF THE PATIENT RETAINED THE FRACTURED TIP. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CURVTEK CARTRIDGE 7MM MEDIUM	INSTRUMENT, SURGICAL	HSZ	BIOMET SPORTS MEDICINE	N/A	785970

Patients

Seq	Age	Sex	Outcome	Treatment
1