NA 04.033.067SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982272119), received between Jan 21, 2020 and Sep 2, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionSep 2, 2021Device-Device Incompatibility; Manufacturing, Packaging or Shipping Problem; Device-Device Incompatibility; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED ON THAT (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, IT WAS NOTICED THAT THE OUTER SLEEVES WERE MIXED UP WITH THE SLEEVES WHICH DID NOT FIT PROPERLY INTO THE AIMING ARM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1)10 / TI CANN FRN / GT 360 / LEFT - SILE. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12417857 ↗
• InjuryJan 21, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO SUBTROCHANTERIC NON-UNION AND A BROKEN FEMORAL RECON NAIL (FRN). THE PATIENT HAD BEEN IMPLANTED ON (B)(6) 2019 HOWEVER, AN IMPLANT FAILURE OF FRN AT AN UNKNOWN DISTAL RECON SCREW HOLE WAS OBSERVED. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICES: UNKNOWN END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), 6.5MM TI RECON SCREW WITH T25 STARDRIVE 80MM (PRODUCT CODE: 04.003.026 LOT #: 1L92918 QTY: 1), 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM (PRODUCT CODE: 04.003.029 LOT #: 1L92908 QTY: 1), 5.0MM TI LOCKING SCREW 40MM- FOR IM NAILS (PRODUCT CODE: 458.940 LOT #: 3L22191 QTY: 1), 5.0MM TI LOCKING SCREW 50MM- FOR IM NAILS (PRODUCT CODE: 458.950 LOT #: 7969804 QTY: 1). THIS REPORT IS FOR ONE 10MM / TI CANN FRN / GT 360MM / LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9611411 ↗