NA 402.880Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982206749), received between Dec 20, 2017 and Jan 22, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 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.

• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN ORIF FOR DISTAL CLAVICLE FRACTURE WITH THE SCREW. DURING THE SURGERY, AFTER REDUCTION, THE PLATE WAS TEMPORARILY FIXED WITH FORCEPS AND THE SCREW WAS INSERTED, BUT THE SURGEON SAID THAT THE BONE HAD BROKEN AT THE SCREW INSERTION POINT. THE SCREW WAS THEN REMOVED, THE BONE WAS REDUCED AGAIN, AND INTERNAL FIXATION WAS PERFORMED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 24146835 ↗
• MalfunctionAug 8, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON JULY 15, 2024, THE SCREW HEADS WERE STRIPPED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT INVOLVES ONE 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939455 ↗
• MalfunctionJul 16, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS WITH A PLATE FOR A FRACTURE OF LEFT CLAVICLE DIAPHYSIS. THE SURGEON INSERTED THE SCREW IN QUESTION TO THE VARIABLE ANGLE (VA) LOCKING HOLE FOR REDUCTION. THE SCREW HEAD BROKE OFF DUE TO OVER-TIGHTENING. THE SHAFT PART OF THE SCREW WAS LEFT IN THE BODY AT THE SURGEON¿S DISCRETION. FIXATION WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT WAS STABLE; THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750750 ↗
• MalfunctionJun 27, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2024, THE PATIENT UNDERWENT AN INITIAL OPEN REDUCTION INTERNAL FIXATION (ORIF SURGERY) FOR THE FIBULA FRACTURE (AO CLASSIFICATION: 44-C). THE SURGEON INSERTED THE SINGLE SCREW FOR FIXATION TO THE FRACTURE, BUT IT BROKE OFF UNDER THE SCREW HEAD DURING INSERTION. THE SURGEON JUDGED THAT THE REMOVING THE BROKEN SCREW WAS IMPOSSIBLE, AND THE BROKEN SCREW WAS REMAINED IN THE BODY AT THE SURGEON¿S DISCRETION. ONLY THE SCREW HEAD WAS REMOVED FROM THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON COMMENTED THAT THE PATIENT WAS YOUNG AND HAD GOOD BONE QUALITY. PATIENT IS LISTED AS STABLE. THIS REPORT IS FOR 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623855 ↗
• InjuryOct 3, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF DISTAL CLAVICLE WITH 5 SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON AUGUST 22, IT WAS CONFIRMED THAT 5 DISTAL SCREWS WERE BROKEN. IT IS UNKNOWN WHEN THE SCREWS BROKE. THE SURGEON COMMENTED THAT THE CAUSE WAS UNKNOWN. THE PATIENT HAD DEMENTIA. CONCOMITANT DEVICE REPORTED: 2.7 TI VA LCP CLAV PL LAT/ CS1/ LFT/ -S (04.112.610S, 640P853) THIS IS REPORT 5 OF 9 FOR (B)(4). THIS REPORT IS 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM.

  Patient problems: Failure of Implant

  MAUDE report 15531406 ↗
• InjuryApr 9, 2018Break; Break

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) WRIST FUSTION SHORT BEND PLATE AND EIGHT (8) SCREWS IN (B)(6) 2014. THE AREA HAD FUSED AND HEALED COMPLETELY. IT WAS SUBSEQUENTLY DETERMINED THAT THE PLATE AND TWO (2) SCREWS HAD BROKEN. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 FOR REMOVAL OF ALL HARDWARE. ALL HARDWARE, WITH THE EXCEPTION OF THE TIPS OF THE TWO (2) BROKEN SCREWS, WERE REMOVED SUCCESSFULLY. THE BROKEN TIPS REMAIN EMBEDDED IN THE PATIENT¿S BONE. NO PATIENT CONSEQUENCE WAS REPORTED. PRODUCT WAS IDENTIFIED UPON RECEIPT AT MANUFACTURER LOCATION, DEVICE ADDED TO THIS REPORT. CONCOMITANT DEVICES REPORTED: 2.7MM CORTEX SCREW 14MM (402.874, LOT 9096654, QUANTITY 1), 3.5MM LOCKING SCREW 20MM (412.106, LOT 9054496, QUANTITY 1), 3.5MM LOCKING SCREW 28MM (412.110, LOT 8634026, QUANTITY 1), 3.5MM STARDRIVE CORTEX SCREW 20MM (04.200.020, LOT 8844355, QUANTITY 1), 3.5MM STARDRIVE CORTEX SCREW 18MM (04.200.018, LOT NUMBER UNKNOWN, QUANTITY 1), SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM CORTEX SCREW 20MM THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7408165 ↗
• MalfunctionDec 20, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017 PATIENT PRESENTED WITH FAILURE OF THE TALONAVICULAR JOINT FUSION. DATE OF THE ORIGINAL SURGERY IS UNKNOWN. IT WAS IDENTIFIED THAT FOUR (4) CANNULATED SCREWS THAT WERE IMPLANTED WITHIN THE PATIENT WERE BROKEN. SURGEON PERFORMED A REVISION SURGERY ON (B)(6) 2017 TO EXTRACT THE BROKEN SCREWS AND IMPLANT NEW DEVICES. PATIENT WAS REVISED TO NEW IMPLANTS WHICH INCLUDED ONE (1) X-PLATE AND FOUR (4) TITANIUM CORTEX SCREWS. AS THE SURGEON WAS TIGHTENING THE LAST TITANIUM SCREW, THE HEAD OFF THE TITANIUM CORTEX SCREW BROKE OFF. THE THREADED PORTION OF THE SCREW WAS LEFT EMBEDDED IN THE PATIENT WHILE THE HEAD OF THE BROKEN SCREW WAS REMOVED. THERE WERE NO ISSUES NOTED WITH THE SCREW DRIVER. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THIS REPORT ADDRESSES THE INTRAOPERATIVE ISSUE OF A BROKEN SCREW. THE POSTOPERATIVE BROKEN SCREWS HAS BEEN CAPTURED UNDER LINKED (B)(4). CONCOMITANT PARTS REPORTED: UNKNOWN SCREW DRIVER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7 MM TI CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20 MM . THIS IS REPORT 1 OF 1 FO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7135541 ↗

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