UNK DEPUY ANKLE SCREW
Received Jun 16, 2009 · Event occurred May 27, 2009
Report 1818910-2009-03240 · MDR key 1403905
Device
Generic name
Total Ankle Prosthesis
Manufacturer
Depuy Orthopaedics, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
- Implant, removal of
Patient
38 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE PATIENT WAS REVISED BECAUSE THE SCREW WAS TOO LONG.
Additional Manufacturer Narrative
EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO REVIEW OF THE INFORMATION PROVIDED, AS THE PART AND LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. PROVIDED INFORMATION STATES THE PATIENT WAS REVISED BECAUSE A SCREW WAS TOO LONG. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
Remedial action
- Other