OXINIUM FEM HD 12/14 32MM +4
Received Jan 10, 2019 · Event occurred Dec 10, 2018
Report 1020279-2019-00102 · MDR key 8233305
Device
Generic name
Absorber, Carbon-dioxide
Manufacturer
Smith & Nephew, Inc.Catalog number
71343204
Lot number
18HM00686
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Injury
- Injury
Narrative
Description of Event or Problem
REVISION SURGERY WAS PERFORMED DUE TO POSTOPERATIVE BONE FRACTURE.
Additional Manufacturer Narrative
THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. A CLINICAL EVALUATION WAS CONDUCTED AND NO CLINICAL RELEVANT DOCUMENTS WERE PROVIDED TO CONDUCT A THOROUGH MEDICAL ASSESSMENT. NO MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. THIS COMPLAINT WILL BE RE-EVALUATED IF MORE INFORMATION BECOMES AVAILABLE. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCHES WITH THE SAME FAILURE MODE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. WITHOUT THE ACTUAL PRODUCT INVOLVED AND/OR DEVICE INFORMATION, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED.