KARLIN SYMMETRY
Received Jul 15, 2021 · Event occurred Apr 15, 2021
Report 3007208013-2021-00021 · MDR key 12178091
Device
Product problems
- Break
- Difficult to Remove
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE ADDITIONAL SURGERY WAS COMPLETED THREE DAYS AFTER THE INCIDENT. THE PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT WAS SENT HOME AND HAS SINCE RECOVERED. AFTER MULTIPLE ATTEMPTS, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED AND PICTURES WERE NOT PROVIDED. WITHOUT THE DEVICE OR LOT NUMBER, AN INVESTIGATION CANNOT BE COMPLETED. BASED ON THE ABOVE INFORMATION, THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
THE LOT NUMBER OF THE DEVICE IS UNKNOWN. THERE HAS BEEN A TOTAL OF (B)(4) SOLD OF ALL LOTS WITH 4 ADDITIONAL COMPLAINTS RECORDED FOR SIMILAR OCCURRENCES. ALL OTHER OCCURRENCES WERE SIGNIFICANTLY USED AND HAS SIGNIFICANT WEAR AND TEAR. THE EVALUATION OF THE PRODUCT IS STILL ANTICIPATED AND ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME IS STILL BEING REQUESTED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE WE HAVE RECEIVED ADDITIONAL INFORMATION OF THE PRODUCT IS RETURNED FOR EVALUATION.
Description of Event or Problem
THE CUSTOMER ALLEGED " DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION THE 0.7 MICRO NERVE HOOK TIP BROKE WHILE IN USE INSIDE THE PATIENT. THE INSTRUMENT WAS REMOVED FROM THE FIELD BY THE SCRUB AND REPLACED WITH A NEW INSTRUMENT. THE NEPTUNE FILTER WAS TAKEN APART TO SEARCH FOR THE TIP IN THE EVENT THAT IT HAD BEEN REMOVED FROM THE PATIENT THROUGH SUCTION. THE FILTER CONTENTS WERE SEARCHED, BTU THE INSTRUMENT TIP WAS NOT FOUND. AN AP X-RAY WAS TAKEN AT THE END OF THE PROCEDURE AND REVIEWED BY THE SURGEON. THERE WAS NO CLEAR DETERMINATION OF ANY METAL RETAINED INSIDE THE PATIENT. THE SURGEON ORDERED A CT SCAN TO LOOK FOR ANY RETAINED OBJECTS. THE CT SCAN FOUND THE REMAINING HOOK PIECE INSIDE THE PATIENT'S SURGICAL SITE. THE DR HAS MET WITH THE PATIENT AGAIN AND IS RECOMMENDING THE PIECE BE REMOVED IN THE OR DUE TO THE RISK OF SCAR TISSUE BUILD UP.