NA 202.214Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982143983), received between Feb 5, 2018 and Oct 18, 2022 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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 8 most recent of 8 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 14MM. THIS IS REPORT 4 OF 14 FOR (B)(4).

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 15628513 ↗
• 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 14MM. THIS IS REPORT 3 OF 14 FOR (B)(4).

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 15628349 ↗
• 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 14 THIS REPORT IS 13 OF 14 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11873647 ↗
• 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 14. THIS REPORT IS 8 OF 14 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11873597 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT HAD UNDERGONE AN ORTHOPEDIC REMOVAL PROCEDURE DUE TO PAIN. ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2012 FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ELBOW. IT WAS NOTED THAT FRACTURE HAD ALREADY HEALED. DEVICES INVOLVED WERE ONE (1) 3.5 MM CORTEX SCREW 16MM, ONE (1) 3.5MM CORTEX SCREW 20MM, ONE (1) 3.5 MM CORTEX SCREW 24MM, ONE (1) 3.5MM CORTEX SCREW 26MM, ONE (1) VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, ONE (1) METAPHYSEAL SCREW, ONE (1) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM, TWO (2) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM, ONE (1) LCP POSTEROLATERAL DISTAL HEMERUS PLATE WITH LATERAL SUPPORT, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, TWO (2) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, AND ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM. ALL IMPLANTS WERE REMOVED EXCEPT FOR FOUR (4) SCREWS AS THE HEADS OF THE SCREWS WERE BROKEN OFF. IT WAS NOT DETERMINED WHICH AMONG THE SCREWS WERE

  Patient problems: Pain

  MAUDE report 8245393 ↗
• MalfunctionOct 29, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2018 DURING THE CLAVICLE FRACTURE SURGERY, THE SURGEON WAS HAVING A HARD TIME WHEN INSERTING TWO (2) CORTEX SCREWS, TWO (2) 14MM LOCKING SCREWS AND ONE (1) 12MM LOCKING SCREW INTO SUPERIOR/ANTERIOR PLATE WITH EXTENSION. FIVE (5) TOTAL SCREWS WERE DIFFICULT TO ENGAGE INTO THE BONE THROUGH THE PLATE. SURGEON WAS COMPLAINING THAT THE SCREWS WERE NOT ENGAGING WITH EASE. SALES CONSULTANT WAS UNABLE TO SEE EXACTLY WHAT WAS GOING ON DUE TO THE DISTANCE OF THE SALES CONSULTANT FROM THE PATIENT. IT WAS SUSPECTED THAT THE STARDRIVE SCREWDRIVER SHAFT T8 WAS WORN. SALES CONSULTANT STATED THAT THERE WAS NO OTHER STARDRIVE SCREWDRIVER SHAFT ON THE TRAY AND WASN'T ABLE TO EXAMINE THE SCREWDRIVER SHAFT BECAUSE THERE WAS ANOTHER PROCEDURE RIGHT AFTER THE FRACTURE REPAIR. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW STARDRIVE RECESS 14MM. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015935 ↗
• MalfunctionOct 29, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2018 DURING THE CLAVICLE FRACTURE SURGERY, THE SURGEON WAS HAVING A HARD TIME WHEN INSERTING TWO (2) CORTEX SCREWS, TWO (2) 14MM LOCKING SCREWS AND ONE (1) 12MM LOCKING SCREW INTO SUPERIOR/ANTERIOR PLATE WITH EXTENSION. FIVE (5) TOTAL SCREWS WERE DIFFICULT TO ENGAGE INTO THE BONE THROUGH THE PLATE. SURGEON WAS COMPLAINING THAT THE SCREWS WERE NOT ENGAGING WITH EASE. SALES CONSULTANT WAS UNABLE TO SEE EXACTLY WHAT WAS GOING ON DUE TO THE DISTANCE OF THE SALES CONSULTANT FROM THE PATIENT. IT WAS SUSPECTED THAT THE STARDRIVE SCREWDRIVER SHAFT T8 WAS WORN. SALES CONSULTANT STATED THAT THERE WAS NO OTHER STARDRIVE SCREWDRIVER SHAFT ON THE TRAY AND WASN'T ABLE TO EXAMINE THE SCREWDRIVER SHAFT BECAUSE THERE WAS ANOTHER PROCEDURE RIGHT AFTER THE FRACTURE REPAIR. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW STARDRIVE RECESS 14MM. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015907 ↗
• InjuryFeb 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2016, PATIENT UNDERWENT SURGERY TO TREAT A LEFT ANKLE FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 2.7MM/3.5MM LCP LATERAL DISTAL PLATE AND TEN (10) SCREWS. IT WAS UNKNOWN TO THE SURGEON IF THE PATIENT WAS ALLERGIC TO METAL AT THE TIME OF THE INITIAL SURGERY. SUBSEQUENTLY THE PATIENT FELT SOME SOFT TISSUE IRRITATION AND THIS WAS DISCOVERED TO BE A REACTION TO METAL ALLERGY. THE SURGEON THEN DECIDED TO REMOVE ALL IMPLANTED DEVICES AND THE CONSTRUCT WITH ALL DEVICES INTACT WAS REMOVED ON (B)(6) 2018. INTRA-OPERATIVE X-RAYS TAKEN SUGGESTED THAT THE FRACTURE HAD COMPLETELY HEALED. THE REMOVAL OF PLATE AND SCREWS CONSTRUCT WAS COMPLETED SUCCESSFULLY AND WITHOUT ANY COMPLICATIONS. NO ADDITIONAL INTERVENTIONS WERE REQUIRED AND THERE WAS NO SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 8 OF 11 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7242088 ↗

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