Device product
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Z-0202-2014
Product summary
- Event
- Event 66485
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2979
- Official record key
device-enforcement:Z-0202-2014
Official wording
Reason: Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Code information: Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257
Distribution pattern: Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
Derived failure modes
-
Unknown
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.