MITEK ACL IMPLANTS

Description of Event or Problem

THE PATIENT REPORTED THAT APPROXIMATELY 6 WEEKS POST OP SHE FELT THAT THE INTRAFIX SHEATH AND SCREW SHE HAD IMPLANTED WAS UNCOMFORTABLE , WAS HANGING OUT TOO MUCH AND SHE COULD FEEL IT UNDER THE SKIN. SHE REPORTED THAT IT WAS NOT PAINFUL AND SHE DID NOT RECEIVE ANY TREATMENT FOR THE CONDITION. THE PATIENT REPORTED THAT SHE HAD FULL MOTION OF THE KNEE BUT WHENEVER SHE WOULD KNEEL IT WAS BE MORE PROMINENT AND UNCOMFORTABLE. THE PATIENT REPORTED SHE HAD THE IMPLANTS REMOVED AND HAS SENT IN PICTURES OF THE DEVICES. THE PATIENT DID NOT HAVE LOT NUMBERS OR PRODUCT CODES FOR THE COMPLAINT DEVICES. THE PATIENT REPORTED THAT NO OTHER FIXATION DEVICE WAS UTILIZED. SEE ASSOCIATED MEDWATCH # 1221934-2014-00395.

Additional Manufacturer Narrative

THE COMPLAINT DEVICE WAS NOT RETURNED. HOWEVER THE PICTURE PROVIDED REVEALS THAT PARTIAL IMPLANT WAS REMOVED DURING RE-SURGERY. THE ORIGINAL SURGERY NOTES DO NOT INDICATE ANY ANOMALIES IN THE TECHNIQUE. THERE WAS NO INFORMATION PROVIDED REGARDING THE RE-SURGERY WHEN THE IMPLANTS WERE REMOVED. THERE WERE NO NEW SCREWS USED IMPLYING THE ACL FIXATION WAS SUCCESSFUL. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. A ROOT CAUSE FOR THIS ISSUE CANNOT BE DETERMINED. BASED ON THE COMPLAINT HISTORY, NO FURTHER ACTION IS WARRANTED. SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN FUTURE, THIS COMPLAINT WILL BE REOPENED AND RE-EVALUATED. HOWEVER, 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.