SWANSON REAMER BUR, MEDIUM, 4MM
Received May 28, 2008 · Event occurred May 5, 2008
Report 1017294-2008-00214 · MDR key 1054689
Device
Generic name
Reamer Burr
Manufacturer
Conmed LinvatecModel number
NACatalog number
00509114400
Lot number
NK
Product problems
- Device, or device fragments remain in patient
- Tip breakage
Patient
NK
- Nonresorbable materials, unretrieved in body
Narrative
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. ACCORDING TO THE REPORTER, THE DEVICE AND PACKAGING WAS DISPOSED OF AT THE USER FACILITY. A REVIEW OF COMPLAINT HISTORY FOR THE PREVIOUS TWO YEARS FOUND NO OTHER REPORTS OF THIS FAILURE FOR THIS DEVICE. A CYTOTOXICITY STUDY USING THE MEM ELUTION METHOD FOUND THIS BUR MATERIAL (17-4 STAINLESS STEEL) NON CYTOTOXIC. THIS BUR HOWEVER, IS NOT INTENDED FOR IMPLANT AND OVER TIME WILL CORRODE. IN ADDITION, THIS ALLOY IS MAGNETIC. THE SURGEON WILL BE PROVIDED ADDITIONAL INFO REGARDING THIS BUR.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THIS BUR TO PERFORM ARTHROPLASTY OF 4 FINGERS, THE BUR TIP BROKE OFF IN THE PT'S BONE. THIS OCCURRED DURING USE OF THE BUR ON THE LAST (FOURTH) FINGER. AT THIS TIME, THE SURGEON CHOSE NOT TO RETRIEVE THE TIP. TO DATE, THE STATUS OF THE PT IS UNK.