FDA Adverse Event Malfunction Summary report: N

MICROAIRE ST TWIST DRILL, STANDARD, 2.4MM DIA. X 127MM

MDR report key: 11699771 · Received April 21, 2021

Report

Report Number
11699771
Event Type
Malfunction
Date Received
April 21, 2021
Date of Event
March 15, 2021
Report Date
April 8, 2021
Manufacturer
MICROAIRE SURGICAL INSTRUMENTS LLC
Product Code
HTW
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

ELDERLY FEMALE PATIENT PRESENTED WITH RIGHT HIP OSTEOARTHRITIS. THE OPERATIVE RECORD INDICATES THAT A 6 CM DISSECTION WAS TAKEN DOWN TO THE FASCIA. THE FASCIA WAS INCISED, AND A SHORT EXTERNAL ROTATION WERE RELEASED AND TAGGED WITH ETHIBOND SUTURE, AN L-SHAPED CAPSULOTOMY WAS PERFORMED AND DISLOCATION NECK CUT WAS MADE AT 10 MM PROXIMAL TO THE LESSER TROCHANTER, ANTERIOR POSTERIOR SUPERIOR RETRACTORS OF THE ACETABULUM WERE CREATED. A DRILL WAS USED TO OPEN THE CORTEX. PRIOR TO ASPIRATION OF THE BONE MARROW, THE DRILL BIT TIP PROXIMATELY 3 CM, BROKE OFF IN THE SUPERIOR ILIUM. IT WAS DECIDED BY THE SURGEON THAT IT WOULD HAVE CAUSED MORE HARM THAN GOOD TO RETRIEVE THE RETAINED DRILL BIT. THE DECISION WAS MADE TO LEAVE THE FOREIGN BODY AND PROCEED WITH THE CASE. A JAMSHIDI PIN WAS PLACED AND MALLETED INTO THE ANTERIOR INFERIOR ILIAC SPINE, APPROXIMATELY 60 CC OF BONE MARROW ASPIRATE WAS RETRIEVED IN THE SYRINGE AND PASSED TO THE BACK TABLE AND OFF THE TABLE FOR PROCESSING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
602259 MICROAIRE ST TWIST DRILL, STANDARD, 2.4MM DIA. X 127MM BIT, DRILL HTW MICROAIRE SURGICAL INSTRUMENTS LLC 8054-012NS 25557

Patients

Seq Age Sex Outcome Treatment
1 23360 DA Other