MDR event
Received Sep 16, 2013 · Event occurred Jan 4, 2013
Report 2520274-2013-01184 · MDR key 3349141
Device
Manufacturer
Synthes UsaProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
24 YR
- Pain
Narrative
Description of Event or Problem
THE RISK MANAGEMENT COORDINATOR REPORTED AN EXPLANT ON (B)(6) 2013. THE PATIENT REPORTED PAIN IN THE LEFT ANKLE. THE SURGEON PERFORMED AN LEFT ANKLE ARTHROSCOPY DEBRIDEMENT AND HARDWARE REMOVAL. DURING THE PROCEDURE THE HOLLOW REAMER BROKE IN HALF DURING REMOVAL. THE HOLLOW REAMER WAS RETRIEVED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS NO HARM CAUSED TO THE PATIENT. ALONG WITH THE REAMER TWO SCREWS ONE SYNDESMOTIC AND ONE UNIDENTIFIED WASHER WAS ALSO REMOVED DURING THE PROCEDURE. THIS REPORT IS FOR AN UNKNOWN WASHER. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.