ATLAS CABLE SYSTEM
Received May 14, 2020 · Event occurred Apr 16, 2020
Report 1030489-2020-00527 · MDR key 10058305
Device
Generic name
Cable
Manufacturer
Warsaw OrthopedicsModel number
NACatalog number
826-213
Lot number
0640587W
Product problems
- Break
- Break
Patient
84 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PATELLA FRACTURE; AND UNDERWENT ARTHRODESIS OF KNEE. INTRA-OP, THE REPORTED CABLE BROKE. THE BROKEN CABLE WAS EXPLANTED WITH NO FRAGMENT OF THE BROKEN PRODUCT REMAINING INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.