Device product
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.
Z-0615-2014
Product summary
- Event
- Event 65007
- Status
- Terminated
- Classification
- Class II
- Quantity
- 290
- Official record key
device-enforcement:Z-0615-2014
Official wording
Reason: Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.
Code information: Part Number 05.001.012, lot number AV18166
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .
Derived failure modes
-
Unknown
Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.