Device product
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
Z-0438-2013
Product summary
- Event
- Event 62918
- Status
- Terminated
- Classification
- Class II
- Quantity
- 156 units
- Official record key
device-enforcement:Z-0438-2013
Official wording
Reason: Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Code information: Product coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07.
Distribution pattern: Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland.
Derived failure modes
-
Unknown
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.