ORTHOSORB LS 1.3MM TPRD PN KIT
Received Dec 2, 2015 · Event occurred Oct 30, 2015
Report 0001825034-2015-04824 · MDR key 5261261
Device
Generic name
Pin, Fixation
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
110010745
Lot number
UNKNOWN
Product problems
- Material Integrity Problem
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A BUNIONECTOMY ON AN UNKNOWN DATE. DURING THE PROCEDURE, A SAW WAS USED TO FLUSH CUT THE PIN. IT WAS NOTED THAT THE PIN WILL BREAK IF IT IS PULLED TOO HARD. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
THIS FOLLOW UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A BUNIONECTOMY. DURING THE PROCEDURE, THE PIN FRACTURED, AND A SAW WAS USED TO FLUSH CUT THE PIN. IT WAS NOTED THAT THE PIN WILL BREAK IF IT IS PULLED TOO HARD. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A BUNIONECTOMY ON (B)(6) 2015. DURING THE PROCEDURE, A SAW WAS USED TO FLUSH CUT THE PIN. IT WAS NOTED THAT THE PIN WILL BREAK IF IT IS PULLED TOO HARD. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.