FAST-FIX DEV
Received Sep 30, 2020 · Event occurred Aug 9, 2020
Report 1219602-2020-01493 · MDR key 10610205
Device
Generic name
Suture, Nonabsorbable, Synthetic, Polyester
Manufacturer
Smith & Nephew, Inc.Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Injury
- Injury
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER A SURGERY WITH FAST FIX 360, THE PATIENT COMMENTED THAT HE BECAME A CRIPPLE BECAUSE OF THE DEVICE. NO OTHER COMPLICATION WERE REPORTED.
Additional Manufacturer Narrative
THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. NO PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY REVIEW, INSTRUCTIONS FOR USE REVIEW, AND RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. A REVIEW OF THE COMPLAINT REVEALED THERE WERE NO PATIENT INJURIES REPORTED AND NO APPARENT PATIENT IMPACT BASED ON THE DETAILS PROVIDED. THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION.