NA 402.894Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982206817), received between Sep 25, 2020 and Sep 25, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K050110, K063049, K112583, K962616); they may or may not involve this specific model.

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.

• InjurySep 25, 2020Off-Label Use; Off-Label Use

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN OPEN REDUCTION FIBULA AND TIBIA PROCEDURE, THE SURGEON IMPLANTED LATERAL DISTAL FIBULAR PLATES AND USED 2.7MM CORTICAL SCREWS IN THE BODY OF THE PLATE INSTEAD OF THE INDICATED 3.5MM SCREWS. AFTER A PREVIOUS PROCEDURE, THE SURGEON DIRECTED THE STAFF TO RETAIN 3.5MM SCREWS AND THEY WERE SENT TO BE STERILIZED. THE SURGEON BEGAN THE PATIENT'S PROCEDURE WITHOUT THE 3.5MM BEING AVAILABLE AS THEY WERE STILL BEING STERILIZED. AFTER BEING ADVISED THAT USING THE 2.7MM CORTICAL SCREWS COULD GENERATED COMPLICATIONS IN THE PATIENT, THE SURGEON PROCEEDED TO IMPLANT THE 2.7MM CORTICAL SCREWS. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 34MM. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10588511 ↗
• InjurySep 25, 2020Off-Label Use; Off-Label Use

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN OPEN REDUCTION FIBULA AND TIBIA PROCEDURE, THE SURGEON IMPLANTED LATERAL DISTAL FIBULAR PLATES AND USED 2.7MM CORTICAL SCREWS IN THE BODY OF THE PLATE INSTEAD OF THE INDICATED 3.5MM SCREWS. AFTER A PREVIOUS PROCEDURE, THE SURGEON DIRECTED THE STAFF TO RETAIN 3.5MM SCREWS AND THEY WERE SENT TO BE STERILIZED. THE SURGEON BEGAN THE PATIENT'S PROCEDURE WITHOUT THE 3.5MM BEING AVAILABLE AS THEY WERE STILL BEING STERILIZED. AFTER BEING ADVISED THAT USING THE 2.7MM CORTICAL SCREWS COULD GENERATED COMPLICATIONS IN THE PATIENT, THE SURGEON PROCEEDED TO IMPLANT THE 2.7MM CORTICAL SCREWS. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 34MM. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10587925 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050110, K063049, K112583, K962616. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen