MITEK RIGIDFIX PLA 3.3MM FEMORAL CROSS PIN KIT

Description of Event or Problem

ON (B)(6) 2014 DEPUY MITEK COMPLAINTS RECEIVED A CALL FROM A SALES REP WHO ITERATED THE FOLLOWING MESSAGE TO US. WHILE VISITING HIS CUSTOMER IN (B)(6) 2012, A SURGEON TOLD THE SALES REP ABOUT A REVISION SURGERY HE RECENTLY PERFORMED. THE ORIGINAL SURGERY WAS AN ACL REPAIR THAT WAS COMPLETED IN (B)(6) 2011 ON A (B)(6) FEMALE PATIENT. THE SURGEON REPORTED THE ORIGINAL PROCEDURE WAS DONE ANTEROMEDIALLY USING THE RIGIDFIX SOFT TISSUE 3.3MM CROSS PIN KIT. THE PATIENT COMPLAINED OF PAIN WHICH LED TO THE REVISION PROCEDURE NINE MONTHS LATER. THE SURGEON REMOVED FRAGMENTS OF THE RIGIDFIX CROSS PINS FROM THE PATIENT'S JOINT SPACE. THE SALE REP STATED THAT THE SURGEON SAID HE WAS NOT FILING A COMPLAINT. THE SALES REP WAS NOT PRESENT FOR EITHER THE ORIGINAL PROCEDURE OR THE REVISION. ON OR AFTER (B)(6) 2014, THE REP CONTACTED A PHYSICIAN¿S ASSISTANT FROM THAT FACILITY. AT THAT TIME, THE PA TOLD THE SALES REP THAT THIS PATIENT¿S KNEE WAS STABLE AND THAT A COMPLETE ACL REPAIR WAS NOT DONE DURING THE REVISION PROCEDURE, ONLY THAT FRAGMENTS WERE REMOVED. SEE ASSOCIATED MEDWATCH #'S 1221934-2014-00065, 1221934-2014-00066, 1221934-2014-00067, AND 1221934-2014-00068.

Additional Manufacturer Narrative

ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK. DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT. THIS REPORT HAS ENTERED DATES OF (B)(6) 2012, THE ACTUAL DATES OCCURRED SOMETIME IN (B)(6) 2012, BUT THE EXACT DAYS IN THE MONTH ARE UNKNOWN.

Additional Manufacturer Narrative

THE COMPLAINT DEVICE HAS NOT BEEN RETURNED. NO FURTHER INFORMATION REGARDING THE PATIENT OR THE EVENT WAS AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT ANY INCIDENT RELATED TO THE COMPLAINT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED ONE DISSIMILAR COMPLAINT WITH NO PATIENT CONSEQUENCES FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. FROM THE COMPLAINT HISTORY, IT SEEMS THAT THIS FAILURE IS AN ANOMALY AND AN ISOLATED INCIDENT. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

Description of Event or Problem

ON FEBRUARY 4, 2014 DEPUY MITEK COMPLAINTS RECEIVED A CALL FROM A SALES REP WHO ITERATED THE FOLLOWING MESSAGE TO US. WHILE VISITING HIS CUSTOMER IN (B)(6) 2012, A SURGEON TOLD THE SALES REP ABOUT A REVISION SURGERY HE RECENTLY PERFORMED. THE ORIGINAL SURGERY WAS AN ACL REPAIR THAT WAS COMPLETED IN JUNE OF 2011 ON A TEENAGE FEMALE PATIENT. THE SURGEON REPORTED THE ORIGINAL PROCEDURE WAS DONE ANTERIOMEDIALLY USING THE RIGIDFIX SOFT TISSUE 3.3MM CROSS PIN KIT. THE PATIENT COMPLAINED OF PAIN WHICH LED TO THE REVISION PROCEDURE NINE MONTHS LATER. THE SURGEON REMOVED FRAGMENTS OF THE RIGIDFIX CROSS PINS FROM THE PATIENT'S JOINT SPACE. THE SALE REP STATED THAT THE SURGEON SAID HE WAS NOT FILING A COMPLAINT. THE SALES REP WAS NOT PRESENT FOR EITHER THE ORIGINAL PROCEDURE OR THE REVISION. ON OR AFTER JANUARY 30, 2014, THE REP CONTACTED A PHYSICIAN'S ASSISTANT FROM THAT FACILITY. AT THAT TIME, THE PA TOLD THE SALES REP THAT THIS PATIENT'S KNEE WAS STABLE AND THAT A COMPLETE ACL REPAIR WAS NOT DONE DURING THE REVISION PROCEDURE, ONLY THAT FRAGMENTS WERE REMOVED. SEE ASSOCIATED MEDWATCH #'S 1221934-2014-00065, 1221934-2014-00066, 1221934-2014-00067, AND 1221934-2014-00068.