NA 04.211.030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982119070), received between Jul 28, 2023 and May 8, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL HUMERUS FRACTURE WITH PLATES AND SCREWS. DURING SURGERY, AFTER USING TWO PLATES TO FIX THE FRACTURE, THE IMAGE SHOWED THAT THE INNER PLATE WAS MISALIGNED. AFTER REMOVING THE PROXIMAL SCREWS, THE PLATE POSITION WAS FINELY ADJUSTED AND THEN REINSTALLED WITH CORTEX SCREWS. DURING THAT PROCESS, THE TWO DISTAL SCREWS IN QUESTION THAT HAD NOT BEEN REMOVED BROKE OFF BELOW THE SCREW HEADS. THE SURGEON REMOVED THE PLATE, PULLED OUT THOSE TWO SCREWS WITH HERCULES PLIERS, AND THEN REINSTALLED THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. THE SURGEON COMMENTED THAT THIS EVENT WAS CAUSED BY EXCESSIVE STRESS TO THE SCREWS BY FORCING THE PLATE INTO PLACE DURING REINSTALLATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25123573 ↗
• MalfunctionApr 10, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A TRANSCONDYLAR FRACTURE OF THE DISTAL HUMERUS. AFTER IMPLANTING A POSTERIOR LATERAL PLATE, THE SURGEON BEGAN IMPLANTING THE MEDIAL PLATE, BUT THREE SCREWS IDLED AND NO TORQUE COULD BE APPLIED. THE FIRST SCREW WAS INSERTED AFTER DRILLING USING A 2.7 VA DRILL GUIDE, BUT THE SCREW IDLED WHEN THE HEAD CAME NEAR TO THE PLATE. THIS SCREW WAS REMOVED BECAUSE A METAL FRAGMENT WAS GENERATED. THE SECOND SCREW WAS INSERTED INTO THE SAME HOLE AS THE FIRST, BUT IT ALSO IDLED. TORQUE COULD BE LIGHTLY APPLIED TO THIS SCREW SO IT WAS LEFT IN THE HOLE. THE THIRD SCREW WAS INSERTED INTO ANOTHER HOLE AFTER DRILLING WITH THE VA DRILL GUIDE, BUT NO TORQUE COULD BE APPLIED. THIS SCREW WAS ALSO LEFT IN THE HOLE. ANOTHER DRILL GUIDE WAS USED AND THE ISSUES WITH SCREW IDLING AND LACK OF TORQUE WERE RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT, IT WAS CONFIRMED VIA X-RAY THAT NO FRAGMENTS REMAINED WITHIN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080481 ↗
• MalfunctionApr 10, 2024Off-Label Use; Device-Device Incompatibility; Material Twisted/Bent; Off-Label Use; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A TRANSCONDYLAR FRACTURE OF THE DISTAL HUMERUS. AFTER IMPLANTING A POSTERIOR LATERAL PLATE, THE SURGEON BEGAN IMPLANTING THE MEDIAL PLATE, BUT THREE SCREWS IDLED AND NO TORQUE COULD BE APPLIED. THE FIRST SCREW WAS INSERTED AFTER DRILLING USING A 2.7 VA DRILL GUIDE, BUT THE SCREW IDLED WHEN THE HEAD CAME NEAR TO THE PLATE. THIS SCREW WAS REMOVED BECAUSE A METAL FRAGMENT WAS GENERATED. THE SECOND SCREW WAS INSERTED INTO THE SAME HOLE AS THE FIRST, BUT IT ALSO IDLED. TORQUE COULD BE LIGHTLY APPLIED TO THIS SCREW SO IT WAS LEFT IN THE HOLE. THE THIRD SCREW WAS INSERTED INTO ANOTHER HOLE AFTER DRILLING WITH THE VA DRILL GUIDE, BUT NO TORQUE COULD BE APPLIED. THIS SCREW WAS ALSO LEFT IN THE HOLE. ANOTHER DRILL GUIDE WAS USED AND THE ISSUES WITH SCREW IDLING AND LACK OF TORQUE WERE RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT, IT WAS CONFIRMED VIA X-RAY THAT NO FRAGMENTS REMAINED WITHIN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080479 ↗
• MalfunctionJul 28, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR DISTAL HUMERUS FRACTURE. THE AFFECTED AREA WAS FIXED IN THE ORDER OF THE MEDIAL PLATE, THEN THE LATERAL PLATE. INITIALLY, THE SCREW WAS INSERTED AT A FIXED ANGLE, BUT WHEN IT WAS CHECKED WITH AN IMAGE INTENSIFIER, IT WAS FOUND THAT THE TIP OF THE SCREW PENETRATED FORWARD. THE SCREW WAS REMOVED AND REINSERTED SEVERAL TIMES, BUT THE ANGLE DID NOT CHANGE SO THE SURGEON REDRILLED WITH A VARIABLE ANGLE AND INSERTED THE SCREW. NEAR THE END OF THE LATERAL PLATE FIXATION, THE SURGEON SAID THAT THE 2ND SCREW FROM THE DISTAL SIDE COULD NOT BE LOCKED AND WAS COMING OUT. THE SCREW CAME OUT, SO NO SCREW WAS INSERTED IN THAT SCREW HOLE. ONLY ONE SCREW COULD BE INSERTED DISTALLY, SO AN ADDITIONAL SCREW WAS INSERTED FROM THE DISTAL LATERAL DIRECTION TO THE PROXIMAL LATERAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 30MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415929 ↗