NA 202.218Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982144003), received between Mar 8, 2018 and Oct 18, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Dull, Blunt” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K033995, K050110, K063049, K111540, K113364); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON PERFORMED A REMOVAL OF HARDWARE DUE TO PAIN AND IRRITATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM. THIS IS REPORT 6 OF 14 FOR (B)(4).

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 15628426 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR THE FIBULA PLATE AND SCREWS AND 2 ASSOCIATED LAG SCREWS. THE SURGEON PERFORMED I&D AND NOTED THAT THE BONE IS MOSTLY HEALED AND APPEARED TO HAVE NO SIGN OF INFECTION. INITIALLY THE PATIENT HAD SURGERY TO REPAIR A FIBULA FRACTURE 4 OR 5 MONTHS AGO. AFTER 3 MONTHS POST OP THERE WAS A SIGN OF INFECTION AND TRIED TO TREAT WITH ANTIBIOTICS WITHOUT SUCCESS. THIS COMPLAINT INVOLVES 11 DEVICES. THIS REPORT IS FOR (1) 2.7 LOCKING SCREW SLF-TPNG SD REC 18. THIS REPORT IS 14 OF 14 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11873652 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR THE FIBULA PLATE AND SCREWS AND 2 ASSOCIATED LAG SCREWS. THE SURGEON PERFORMED I&D AND NOTED THAT THE BONE IS MOSTLY HEALED AND APPEARED TO HAVE NO SIGN OF INFECTION. INITIALLY THE PATIENT HAD SURGERY TO REPAIR A FIBULA FRACTURE 4 OR 5 MONTHS AGO. AFTER 3 MONTHS POST OP THERE WAS A SIGN OF INFECTION AND TRIED TO TREAT WITH ANTIBIOTICS WITHOUT SUCCESS. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 2.7 LOCKING SCREW SLF-TPNG T8 SD REC 18. THIS REPORT IS 10 OF 14 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11873613 ↗
• InjuryMar 8, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A 3.5MM LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL HUMERUS PLATE, 3.5MM CORTEX SCREWS (QUANTITY OF 3), 2.7MM LOCKING SCREWS (QUANTITY OF 2) AND 3.5MM LOCKING SCREWS (QUANTITY OF 4) FOR AN ORIF (OPEN REDUCTION INTERNAL FIXATION) OF A HUMERUS IN (B)(6) 2017. A NONUNION WAS NOTED ON AN UNKNOWN DATE. X-RAYS WERE TAKEN ON AN UNKNOWN DATE AND SHOWED THAT THE (TWO) 2.7MM LOCKING SCREWS WERE NOT CONNECTED TO THE PLATE. BOTH SCREWS WERE STUCK IN THE BONE FULLY INTACT, CAUSING MINIMAL FIXATION. THE X-RAYS ALSO SHOWED THAT THE THREADS ON ONE OF THE 2.7MM LOCKING SCREW HEADS STRIPPED. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018. ALL HARDWARE WAS EASILY REMOVED. PATIENT WAS REVISED TO A VARIABLE ANGLE (VA) PLATE, SCREWS AND VIVIGEN FORMABLE BONE GRAFTS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW, SELF-TAPPING 20MM (PART 204.820, LOT NUMBER UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW, SELF-TAPPING 24MM (PART 204.824 LOT NUMBER UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW, SELF-TAPPING 28MM (PART 204.828 LOT NUMBER UNKNOWN,

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7325498 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033995, K050110, K063049, K111540, K113364. 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-1274-2014 · Jan 7, 2014 · Terminated
  Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bon
• 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
• Z-2278-2013 · Mar 8, 2013 · Terminated
  Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults