NA 02.211.056Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982053794), received between Jul 11, 2022 and Apr 6, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE USED DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OLECRANON PROCEDURE ALONG WITH THE PRODUCT 2.7/3.5 VA-LCP PROXIMAL OLECRANON PLATE. ONE OF THE PROXIMAL HOLES WAS INITIALLY FILLED WITH A 2.7 METAPHYSEAL SCREW FOR INITIAL FIXATION AND REPLACED WITH THE 2.7 VA LOCKING SCREW AND AN ADDITIONAL SCREW INTO THE TWO MOST PROXIMAL HOLE IN THE PLATE. NEITHER OF THESE SCREWS WOULD LOCK INTO THE PLATE. THE SURGEON TRIED TWICE AND WAS FRUSTRATED BECAUSE THIS LOCKING TECHNOLOGY WAS CRUCIAL TO THE FRACTURE PATTERN AND PATIENT BONE QUALITY. THE SCREWS WERE REMOVED AND REPLACED WITH ALTERNATIVE SCREWS BUT THEY ALSO DID NOT LOCK AS THEY NORMALLY WOULD. THE SCREWS WERE RETRIEVED AND THE SCRUB TECHNICIAN ATTEMPTED TO LOCK THEM INTO A REMOVED PLATE AND THEY WOULD NOT FULLY SEAT OR LOCK. ALL SURGICAL TECHNIQUES WERE FOLLOWED. IT WAS UNKNOWN WHETHER THERE WAS ANY PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 56MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690123 ↗
• MalfunctionOct 10, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2022, THAT WHILE INSERTING A 2.7 VA LOCKING SCREW INTO A PLATE, SOME METAL SHAVINGS CAME OFF OF THE HEAD. IT IS POSSIBLE BECAUSE THE SCREW MAY HAVE NOT BEEN CENTERED IN THE SCREW HOLE WHEN THE SURGEON DRILLED. THE SHAVINGS WERE REMOVED AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1)2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 56 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15572238 ↗
• MalfunctionJul 11, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE DRILL BIT WAS DISCOVERED TO BE DULL. IT HAD NO IMPACT ON THE PATIENT. ADDITIONALLY, A SCREW WAS FOUND WITH ITS HEAD IN POOR CONDITION AND THE SURGEON DECIDED NOT TO USE IT IN THE SURGERY. THIS REPORT IS FOR A 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 56MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14975733 ↗