CONFIDENCE HYDRAULIC PUMP
Received Jan 24, 2020
Report 1526439-2020-00446 · MDR key 9628077
Device
Generic name
Hook,surgical,gen & Plastic Surgery
Manufacturer
Depuy Spine IncCatalog number
283906100
Lot number
260309
Product problems
- Migration or Expulsion of Device
- Migration or Expulsion of Device
Patient
Not reported
- No Consequences Or Impact To Patient
- No Patient Involvement
- No Consequences Or Impact To Patient
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative
COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT AN UNKNOWN SURGERY TO STOP THE CEMENT FLOW THE PRESSURE IN THE HYDRAULIC PUMP IS REDUCED BY UNSCREWING THE HOLDER. WHILE UNSCREWING THE HOLDER THE INNER THREAD GOT JAMMED. THE INNER PISTON GOT LIFTED OUT WHICH RESULTED IN THE LIQUID TO FLOW OUT. THE INNER PISTON WAS PUT BACK IN PLACE AND COMPLETE THE CEMENT AUGMENTATION SUCCESSFULLY. THERE WERE NO FRAGMENTS CREATED. THE SURGERY WAS DELAYED TWO MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 2 FOR (B)(4).