PATH(R) DRIVE SHAFT

MDR report key: 4126716 · Received September 29, 2014

Report

Report Number: 3010536692-2014-01443
Event Type: Death
Date Received: September 29, 2014
Date of Event: September 23, 2014
Report Date: September 24, 2014
Manufacturer: MICROPORT ORTHOPEDICS INC.
Product Code: HTW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS IS THE SAME EVENT AS 3010536692-2014-01435, -01436, -01437, -01438, -01439, -01440, -01441, -01442.

Description of Event or Problem · 1

PER SALES REP, "SURGICAL PROCEDURE WAS SUPERPATH ON 350+ LB 5'3" (B)(6) FEMALE WITH OA. SUPERPATH DRILL PIN WAS USED TO PREPARE FOR ONE 25MM SCREW THROUGH VERY HARD BONE. AFTER DIFFICULT DRILL PENETRATION THE DRILL FINALLY DRILLED PILOT HOLE AND WENT THROUGH CORTEX AND SCREW WAS PLACED WITH GOOD PURCHASE. PROCEDURE WAS COMPLETED AND PATIENT WAS CLOSED WITHOUT INCIDENT. WHEN PATIENT WAS ROLLED ON TO BACK AND PUT ON GURNEY , BLOOD PRESSURE DROPPED SIGNIFICANTLY. AFTER SOME TIME BY STAFF TO INFUSE AND ATTEMPT TO STABILIZE, PATIENT WAS MOVED TO CATH LAB FOR CV SURGEON TO LOOK FOR BLEEDER. TOO SICK TO OPEN ABDOMEN TO EXPLORE. PATIENT EXPIRED FROM SIGNIFICANT BLOOD LOSS AFTER MULTIPLE ATTEMPTS AND MULTIPLE UNITS OF BLOOD PRODUCTS INFUSED. AN APPARENT BLEED FROM ILIAC VEIN THAT DID NOT PRESENT A PROBLEM DURING SURGICAL PROCEDURE."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
604358	PATH(R) DRIVE SHAFT	HIP INSTRUMENT	HTW	MICROPORT ORTHOPEDICS INC.		1529746

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Death