PAPAVERO-CASPAR SPEC SLIM-PROF 90X13MM

Additional Manufacturer Narrative

EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: THE DECONTAMINATED INSTRUMENTS ARE AVAILABLE FOR INVESTIGATION. A FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO BROKEN THREADS ON THE DEVICE. THE OUTER THREADS OF THE SCREW HAVE BEEN EXAMINED AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS AS WELL AS THE INNER THREADS OF THE LEGS OF THE INSTRUMENT. THE INSTRUMENT IS ACCORDING TO SPECIFICATIONS. THE SCREW HAD TO BE REMOVED BY FORCE. THE THREAD OF THE SCREW IS DAMAGED. A GAUGE TEST WAS PERFORMED AND IT WAS DETERMINED THAT THE INNER THREAD OF THE LEG IS DAMAGED, THE THREAD ON THE OTHER LEG OF THE DEVICE WAS WITHIN SPECIFICATION. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR VALID SPECIFICATION AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF THE INGESTION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT MAINTENANCE OF THE DEVICE. THE INSTRUMENT OF THIS COMPLAINT IS MOST LIKELY BROKEN DUE TO AN INSUFFICIENT LUBRICATION DURING THE REPROCESSING.

Description of Event or Problem

COUNTRY OF COMPLAINT: (B)(6). DURING THE PROCEDURE, THERE WAS A TEMPORARY IMPAIRMENT OF THE NASAL MUCOSA. THE INSTRUMENT COULD NOT BE TURNED BACK TOGETHER INTRAOPERATIVELY. THE SCREW APPEARED TO BE DAMAGED AND WOULD NOT ALLOW THE INSTRUMENT TO OPEN AND CLOSE. THERE APPEARED TO BE TEMPORARY DAMAGE OF THE PATIENT'S NASAL MUCOSA THAT WILL HEAL FULLY AND WILL MOST LIKELY NOT NEGATIVELY INFLUENCE THE PATIENT IN THE FUTURE. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2018-00350; 9610612-2018-00351; 9610612-2018-00353.