GATES-ENLARGERS C.A.

Additional Manufacturer Narrative

NO PRODUCT OR LOT # HAS BEEN MADE AVAILABLE FOLLOWING TWO (2) DOCUMENTED REQUESTS FOR UPDATE. NO FURTHER INVESTIGATION POSSIBLE. THE COMPLAINT IS REGISTERED AND COULD BE RE-OPENED ONCE ADDITIONAL INFORMATION SHALL BE MADE AVAILABLE. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE. 2 (TWO) UNSUCCESSFUL REQUESTS TO RETRIEVE SUSPECT PRODUCT OR INVESTIGATION RESULT HAVE BEEN MADE AND DOCUMENTED. COMPLAINT WILL BE REOPENED IF SUSPECT PRODUCT OR INVESTIGATION RESULT ARRIVES PER 8000-SOP-038.

Additional Manufacturer Narrative

THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT GATES-ENLARGERS C.A. BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION HAS BEEN REQUESTED.