TRITON DTS PKG US STD
Received Mar 5, 2019 · Event occurred Feb 8, 2019
Report 9616086-2019-00010 · MDR key 8389946
Product problems
- Retraction Problem
- Retraction Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
ONE TRITON DTS PKG US STD (PART NUMBER 2841 / SERIAL NUMBER (B)(4)/ LOT NUMBER 1018) WAS RETURNED FOR EVALUATION. THE UNIT WAS TESTED AND FOUND TO BE WORKING PROPERLY. THE COMPLAINT REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THERE WAS NO INFORMATION IN THE DHR THAT WOULD INDICATE A PROBLEM THAT CONTRIBUTED TO THE REPORTED COMPLAINT. TRENDING DATA WAS REVIEWED AND NO TREND WAS IDENTIFIED THAT WOULD INDICATE A SYSTEMIC PROBLEM. NO FURTHER ACTION IS WARRANTED.
Additional Manufacturer Narrative
THERE IS NO INDICATION THAT THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. IF THE DEVICE IS RETURNED, THE DEVICE WILL BE EVALUATED AND A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE TRACTION DEVICE WAS EXPERIENCING INCONSISTENT ROPE RECOIL. THE ROPE STARTS MAKING A CLICKING SOUND AND STOPS WORKING. THERE IS NO INDICATION THAT THERE WAS ANY PATIENT INVOLVEMENT OR PATIENT HARM.