VariAx 52-27014SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154699834), received between Feb 26, 2021 and Feb 26, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED: "HOSPITAL NAME: (B)(6). THE PATIENT WAS ADMITTED TO OUR HOSPITAL BECAUSE "ABOUT 2 YEARS AFTER THE REPLANTATION OF THE RIGHT HAND 2-5 FINGERS, INTERNAL FIXATION WAS REQUIRED TO BE REMOVED". 8 MONTHS AGO, HE WAS ADMITTED TO OUR HOSPITAL FOR "JOINT LYSIS" BECAUSE OF "JOINT STIFFNESS AFTER REPLANTATION OF RIGHT HAND 2-5 FINGERS". POSTOPERATIVE IMPROVEMENT AND DISCHARGE, OUTPATIENT FOLLOW-UP, LIMITED RIGHT 2-5 FINGER FLEXOR ACTIVITY, OUTPATIENT VISIT IN OUR HOSPITAL ON (B)(6) 2020, REEXAMINATION X-RAY FILM SHOWED "POSTOPERATIVE REVIEW OF RIGHT HAND TRAUMA, FIXATION OF THE SECOND METACARPAL PLATE AND SCREW, GOOD POSITION OF THE BROKEN END; THE THIRD AND FOURTH METACARPAL CARPAL JOINTS AND PART OF THE CARPAL BONES CAN BE FIXED WITH MULTIPLE KIRSCHNER PINS IN A GOOD POSITION. NOW FOR FURTHER OPERATION, THE TENDON IS RELEASED AND INTERNAL FIXATION IS REMOVED. (B)(6) 2020: "INTERNAL FIXATION WAS PERFORMED WITH BRACHIAL PLEXUS BLOCK PLUS VEIN OCCLUSION, AND RIGHT EXTENSOR TENDON 2-5 WAS RELEASED." DURING THE OPERATION, 1 STEEL PLATE +5 SCREWS WERE REMOVED, AND TWO SCREWS WERE REMOVED WITH SPECIAL TOOLS, WHICH WOULD NOT ROTATE AND SLIP. THE THREAD ON THE SCREW BECOMES SHALLOW. BUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11387073 ↗
• MalfunctionFeb 26, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED: "HOSPITAL NAME: (B)(6). THE PATIENT WAS ADMITTED TO OUR HOSPITAL BECAUSE "ABOUT 2 YEARS AFTER THE REPLANTATION OF THE RIGHT HAND 2-5 FINGERS, INTERNAL FIXATION WAS REQUIRED TO BE REMOVED". 8 MONTHS AGO, HE WAS ADMITTED TO OUR HOSPITAL FOR "JOINT LYSIS" BECAUSE OF "JOINT STIFFNESS AFTER REPLANTATION OF RIGHT HAND 2-5 FINGERS". POSTOPERATIVE IMPROVEMENT AND DISCHARGE, OUTPATIENT FOLLOW-UP, LIMITED RIGHT 2-5 FINGER FLEXOR ACTIVITY, OUTPATIENT VISIT IN OUR HOSPITAL ON (B)(6) 2020, REEXAMINATION X-RAY FILM SHOWED "POSTOPERATIVE REVIEW OF RIGHT HAND TRAUMA, FIXATION OF THE SECOND METACARPAL PLATE AND SCREW, GOOD POSITION OF THE BROKEN END; THE THIRD AND FOURTH METACARPAL CARPAL JOINTS AND PART OF THE CARPAL BONES CAN BE FIXED WITH MULTIPLE KIRSCHNER PINS IN A GOOD POSITION. NOW FOR FURTHER OPERATION, THE TENDON IS RELEASED AND INTERNAL FIXATION IS REMOVED. (B)(6) 2020 "INTERNAL FIXATION WAS PERFORMED WITH BRACHIAL PLEXUS BLOCK PLUS VEIN OCCLUSION, AND RIGHT EXTENSOR TENDON 2-5 WAS RELEASED". DURING THE OPERATION, 1 STEEL PLATE +5 SCREWS WERE REMOVED, AND TWO SCREWS WERE REMOVED WITH SPECIAL TOOLS, WHICH WOULD NOT ROTATE AND SLIP. THE THREAD ON THE SCREW BECOMES SHALLOW. BUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386980 ↗