NA 202.876Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982145079), received between Sep 15, 2020 and Jun 1, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K010321, K050110, K063049, K102694, K112583, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREW IN QUESTION SPLIT, SEPARATING THE HEAD OF THE SCREW FROM THE SHAFT. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037943 ↗
• MalfunctionAug 19, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE DRILL BIT BROKE IN THE MIDDLE OF THE DRILL. SEVERAL SCREW HEADS APPEARED TO HAVE A BAD HEAD AND WERE NOT USED IN SURGERY. SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS NOTED AS OK. THIS IS REPORT 7 OF 11 FOR (B)(4). THIS REPORT IS FOR A CORTEX SCREW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260399 ↗
• InjuryNov 3, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) RIGHT LATERAL MALLEOLUS PROCEDURE OF AN ANKLE, THE SCREW HEAD SHEARED OFF THE SHAFT OF THE SCREW AS THE SURGEON WAS TIGHTENING IT MANUALLY. THE SURGEON APPLIED A 5H 2.7MM VA-LCP LATERAL DISTAL FIBULA LOCKING PLATE TO THE PATIENT USING TWO (2) 1.6MM K-WIRES TO TEMPORARILY HOLD THE PLATE IN PLACE. THEN DRILLED THE 2ND MOST PROXIMAL 2.7MM CORTEX SCREW HOLE USING A 2.0 DRILL BIT. THE SURGEON THEN MEASURED FOR THE SCREW AND BEGAN IMPLANTING A 16MM X 2.7MM (202.876) T8 STARDRIVE RECESS CORTEX SCREW. THE SCREWS WERE IMPLANTED USING POWER, THEN FINALLY TIGHTENED SCREW WITH A MANUAL SCREWDRIVER. AS HE WAS TIGHTENING MANUALLY, THE SCREW HEAD SHEARED OFF THE SHAFT OF THE SCREW. A BROKEN HARDWARE REMOVAL SET WAS ASKED. FRAGMENTS WERE GENERATED BUT WERE NOT REMOVED. IT WAS DECIDED TO LEAVE THE SHAFT OF THE SCREW IN THE FIBULA RATHER THAN TREPHINING IT PUT AND CAUSING MORE TRAUMA TO THE BONE. THERE WERE A 2 MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 1 O

  Patient problems: Foreign Body In Patient

  MAUDE report 12747943 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO PAIN. PATIENT WAS ORIGINALLY IMPLANTED WITH ONE (1) VARIABLE LOCKING COMPRESSION PLATE, TWO (2) CORTEX SCREWS, AND FIVE (5) LOCKING SCREWS ON UNKNOWN DATE. THE SURGEON REMOVED THE PLATE AND SCREWS SUCCESSFULLY AND NOTHING WAS BROKEN. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/2H SHAFT/RIGHT (PART # 02.111.720, LOT # UNKNOWN, QUANTITY 1); 2.4MM VA LOCKING SCREW STARDRIVE 20MM (PART # 02.210.120, LOT # UNKNOWN, QUANTITY 4); 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART # 202.876; LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10667184 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO PAIN. PATIENT WAS ORIGINALLY IMPLANTED WITH ONE (1) VARIABLE LOCKING COMPRESSION PLATE, TWO (2) CORTEX SCREWS, AND FIVE (5) LOCKING SCREWS ON UNKNOWN DATE. THE SURGEON REMOVED THE PLATE AND SCREWS SUCCESSFULLY AND NOTHING WAS BROKEN. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/2H SHAFT/RIGHT (PART # 02.111.720, LOT # UNKNOWN, QUANTITY 1); 2.4MM VA LOCKING SCREW STARDRIVE 20MM (PART # 02.210.120, LOT # UNKNOWN, QUANTITY 4); 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART # 202.876; LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10667156 ↗
• 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 4 OF 7 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10536352 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010321, K050110, K063049, K102694, K112583, 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-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor