VARIAX 657316Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327086874), received between Dec 6, 2018 and May 16, 2023 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A VARIAX CLAVICULA PLATE REMOVAL, WHILST REMOVING THE SCREWS AND PLATE THE SURGEON NOTICED SOME METAL PARTICLES IN THE WOUND. ADDITIONAL INFORMATION: THE REASON FOR THE REMOVAL OF THE PLATE WAS THE DISCOMFORT IT CAUSED. THERE WAS NO DEBRIS LEFT IN THE PATIENT.

  Patient problems: Discomfort

  MAUDE report 16937703 ↗
• MalfunctionNov 15, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS METAL DEBRIS AFTER REMOVING THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796156 ↗
• MalfunctionNov 15, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS METAL DEBRIS AFTER REMOVING THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796154 ↗
• MalfunctionNov 15, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS METAL DEBRIS AFTER REMOVING THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796116 ↗
• MalfunctionMay 10, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "VARIAX 2 T10 LOCKING SCREWS WERE NOT ENGAGING WITH THE DISTAL CLUSTER HOLES IN THE ANATOMIC FIBULA PLATES. 4 SCREWS IN A ROW. IT HAPPENED WHILE TRYING TO LOCK THE SCREWS TO THE PLATE. PROLONGATION OF THE CASE DUE TO INSERTING, NOT ENGAGING, REMOVING, DRILLING AGAIN, MEASURING AGAIN AND IMPLANTING A SHORTER LOCKING SCREW TO ONLY HAVE IT NOT ENGAGE AGAIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803693 ↗
• MalfunctionApr 14, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "VARIAX 2 T10 LOCKING SCREWS WERE NOT ENGAGING WITH THE DISTAL CLUSTER HOLES IN THE ANATOMIC FIBULA PLATES. 4 SCREWS IN A ROW. IT HAPPENED WHILE TRYING TO LOCK THE SCREWS TO THE PLATE. PROLONGATION OF THE CASE DUE TO INSERTING, NOT ENGAGING, REMOVING, DRILLING AGAIN, MEASURING AGAIN AND IMPLANTING A SHORTER LOCKING SCREW TO ONLY HAVE IT NOT ENGAGE AGAIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668553 ↗
• MalfunctionAug 31, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  INTRAOPERATIVE DETECTION OF INADEQUATE SCREW RETENTION WITH CONSIDERABLE FORMATION OF METAL SPLINTERS.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 10474737 ↗
• MalfunctionDec 18, 2019Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY A CUSTOMER "DURING THE INTERVENTION, A METAL PART SEPARATED FROM THE THREAD OF THE VARIAX SCREW. THE METAL PART AND THE SCREW WERE KEPT BUT NOT DECONTAMINATED. THE SURGEON WAS ABLE TO RETRIEVE THE METAL PART THAT HAD DISENGAGED FROM THE SCREW. METAL PART AND SCREWS PUT IN A POT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9490932 ↗
• InjuryNov 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "TREATED REVISION SURGERY DUE TO BACK OUT OF SCREWS. REPLACES PLATE THE SCREW."

  Patient problems: Injury

  MAUDE report 9351165 ↗
• MalfunctionOct 14, 2019Difficult to Insert; Device Slipped; Difficult to Insert

  IT COULDN'T LOCK ON THE PLATE. ANOTHER SCREW WAS USED AND COULD LOCK. NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9188155 ↗
• InjuryJul 29, 2019Detachment of Device or Device Component

  CLAVICLE REVISION CASE; REVISION WAS DUE TO PREVIOUS PLATE AND SCREWS PULLING OUT FROM BONE. SURGEON BELIEVES THIS WAS DUE TO THE PATIENT 'LIFTING WEIGHTS' IN THE GYM EARLIER THAN ADVISED AFTER SURGERY. REVISION CASE WENT ACCORDING TO PLAN WITH NO ISSUES ENCOUNTERED. PATIENT WAS COMPLIANT AND IN A SLING FOR 2 MONTHS. PATIENT IS ALSO A HEAVY SMOKER AND WENT BACK TO WORK AS A CONCRETER AFTER 2 MONTHS POST CASE.

  Patient problems: No Code Available

  MAUDE report 8839483 ↗
• InjuryJul 29, 2019Detachment of Device or Device Component

  CLAVICLE REVISION CASE; REVISION WAS DUE TO PREVIOUS PLATE AND SCREWS PULLING OUT FROM BONE. SURGEON BELIEVES THIS WAS DUE TO THE PATIENT 'LIFTING WEIGHTS' IN THE GYM EARLIER THAN ADVISED AFTER SURGERY. REVISION CASE WENT ACCORDING TO PLAN WITH NO ISSUES ENCOUNTERED. PATIENT WAS COMPLIANT AND IN A SLING FOR 2 MONTHS. PATIENT IS ALSO A HEAVY SMOKER AND WENT BACK TO WORK AS A CONCRETER AFTER 2 MONTHS POST CASE.

  Patient problems: No Code Available

  MAUDE report 8839395 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem

  COMPLAINANT CALLED ON BEHALF OF PATIENT, STATING PATIENT HAD STRYKER SCREWS AND NAILS USED IN THEIR BROKEN ANKLE IN (B)(6) 2018. SINCE THIS DATE, PATIENT HAS BEEN HAVING ALLERGIC REACTIONS AND IT HAS NOT YET BEEN CONFIRMED WHAT IS THE CAUSE.

  Patient problems: Reaction

  MAUDE report 8605980 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem

  COMPLAINANT CALLED ON BEHALF OF PATIENT, STATING PATIENT HAD STRYKER SCREWS AND NAILS USED IN THEIR BROKEN ANKLE IN (B)(6) 2018. SINCE THIS DATE, PATIENT HAS BEEN HAVING ALLERGIC REACTIONS AND IT HAS NOT YET BEEN CONFIRMED WHAT IS THE CAUSE.

  Patient problems: Reaction

  MAUDE report 8605926 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem

  COMPLAINANT CALLED ON BEHALF OF PATIENT, STATING PATIENT HAD STRYKER SCREWS AND NAILS USED IN THEIR BROKEN ANKLE IN (B)(6) 2018. SINCE THIS DATE, PATIENT HAS BEEN HAVING ALLERGIC REACTIONS AND IT HAS NOT YET BEEN CONFIRMED WHAT IS THE CAUSE.

  Patient problems: Reaction

  MAUDE report 8605921 ↗
• MalfunctionDec 6, 2018Appropriate Device Problem Term/Code Not Available

  AS REPORTED: "I WAS THE REP FOR [SURGEON] WHILE USING OUR FIBULA PLATE. THERE WERE TWO LOCKING SCREWS ON THE DISTAL END OF THE FIBULA PLATE THAT WOULDN'T LOCK DOWN IN THE PLATE CORRECTLY...THE TECHNIQUES THAT WERE USED TO IMPLANT THE SCREWS WERE CORRECT. WE USED THE CORRECT DRILL BIT WITH ITS CORRESPONDING DRILL GUIDE AS WELL. [SURGEON] EXPLANTED THESE TWO SCREWS AND REPLACED THEM WITH TWO OTHER LOCKING SCREWS. THE TWO REPLACEMENT SCREWS WENT IN CORRECTLY UNDER THE SAME TECHNIQUE...[SURGEON] WOULD LIKE TO HAVE THIS SITUATION REPORTED SO THAT WE CAN INVESTIGATE ANY REASONS OF WHY THE LOCKING SCREWS WEREN'T FIXATING PROPERLY".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8139812 ↗