MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. SUPERPATH(TM) SCREW DRILL; HIP INSTRUMENT

Catalog Number 2007-1007

Device Problem Difficult to Advance (2920)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 09/23/2014

Event Type  Death  

Event Description

Per sales rep, "surgical procedure was superpath on (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.".

Manufacturer Narrative

This is the same event as 3010536692-2014-01435, -01436, -01437, -01438, -01439, -01440, -01441, -01443.

• Brand Name: SUPERPATH(TM) SCREW DRILL
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 901867-441
• MDR Report Key: 4126434
• MDR Text Key: 4938098
• Report Number: 3010536692-2014-01442
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 2007-1007
• Device Lot Number: 1538787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/23/2014
• Event Location: Hospital
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Weight: 159