INTRAMEDULLARY NAIL EXTRACTION STEINMANN PIN
Received Jan 19, 2017 · Event occurred Dec 6, 2016
Report 0001822565-2017-00240 · MDR key 6264951
Device
Generic name
Trauma Instrument
Manufacturer
Zimmer, Inc.Model number
NACatalog number
00040902100
Lot number
63248526
Product problems
- Bent
- Bent
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. THE EVENT DID NOT LEAD TO A SERIOUS INJURY, AND IS NOT LIKELY TO LEAD TO A SERIOUS INJURY IF IT WERE TO REOCCUR. THE INITIAL REPORT WAS SENT IN ERROR AND SHOULD BE VOIDED.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.(B)(4). THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED.
Description of Event or Problem
IT IS REPORTED THAT WHEN THE PACKAGING WAS OPENED FOR THE PIN, IT WAS NOTICED TO BE BENT PRIOR TO USE. ANOTHER DEVICE WAS USED FOR SURGERY.