NA 202.212Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982143969), received between Feb 6, 2018 and Oct 18, 2022 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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 12MM. THIS IS REPORT 2 OF 14 FOR (B)(4).

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 15628362 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020 THAT A PATIENT UNDERWENT ULNAR REDUCTION SURGERY OF THE RIGHT WRIST ON (B)(6) 2016. THE PATIENT HAS EXPERIENCED HYPERSENSITIVITY SOMETIMES WHERE HER ARM IS NEAR AN ELECTRICITY SOURCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10536595 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020 THAT A PATIENT UNDERWENT ULNAR REDUCTION SURGERY OF THE RIGHT WRIST ON (B)(6) 2016. THE PATIENT HAS EXPERIENCED HYPERSENSITIVITY SOMETIMES WHERE HER ARM IS NEAR AN ELECTRICITY SOURCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10536307 ↗
• 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 12MM. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015951 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2018 TO TREAT AN ANKLE FRACTURE. X-RAY TAKEN ON AN UNKNOWN POSTOPERATIVE DATE REVEALED MALREDUCTION. THE INITIAL PLATE PLACEMENT PUT THE FIBULA IN VALGUS. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 FOR A HARDWARE REMOVAL. THE PLATE WAS REMOVED, AND A 1/3 TUBULAR WAS USED FOR FINAL FIXATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 12MM. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7996685 ↗
• MalfunctionJun 18, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE ON (B)(6) 2018. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO INSERT A 2.7MM LOCKING SCREW INTO THE DISTAL FIBULAR PLATE, BUT THE LOCKING SCREW WOULD NOT GRIP THE THREADS OF THE PLATE. THE SCREW WAS EASILY REMOVED AND REPLACED WITH ANOTHER 2.7MM LOCKING SCREW. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 5 MINUTES. NO PATIENT CONSEQUENCE WAS REPORTED. CONCOMITANT DEVICES REPORTED: DISTAL FIBULAR PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7611764 ↗
• InjuryFeb 6, 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 12MM. THIS IS REPORT 3 OF 11 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7243583 ↗

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