PRELUDE PF IMPACTOR

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

Additional Manufacturer Narrative

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Description of Event or Problem

IT WAS REPORTED THAT DURING AN INITIAL LEFT KNEE PROCEDURE ON (B)(6) 2015, THE REAMER JAMMED INTO THE LEFT CUT GUIDE AND THE IMPACTOR FRACTURED. DUE TO THE REAMER JAMMING, THE GUIDE MOVED WHICH CAUSED ONE OF THE GUIDE PINS TO FRACTURE. THE FRACTURED PIECE OF THE PIN WAS RETAINED BY THE PATIENT. THE SURGERY WAS COMPLETED WITH A DIFFERENT GUIDE.

Additional Manufacturer Narrative

EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. PRODUCT WAS DETERMINED TO HAVE RECEIVED EXCESSIVE FORCE APPLIED DURING IMPLANTATION. THE FEATURES ASSOCIATED WITH THE FRACTURE POINT WERE WITHIN DESIGN SPECIFICATIONS.

Additional Manufacturer Narrative

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03749 / 03750).

Description of Event or Problem

IT WAS REPORTED THAT DURING AN INITIAL LEFT KNEE PROCEDURE ON (B)(6) 2015, THE IMPACTOR FRACTURED CAUSING IT TO JAM INTO THE 8W LEFT CUT GUIDE AND MOVING THE GUIDE. THIS CAUSED ONE OF THE PINS TO FRACTURE INSIDE OF THE PATIENT. THE FRACTURED PIECE COULD NOT BE REMOVED. THE SURGEON WAS ABLE TO REPLACE THE GUIDE AND CONTINUE THE SURGERY WITHOUT ISSUE.

Additional Manufacturer Narrative

UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.