NA 202.874Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982145062), received between Dec 18, 2018 and Jan 24, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JANUARY 14, 2025, TWO SCREWS WERE NOT ENGAGING WITH THE SCREWDRIVER AND A DRILL BIT BROKE. IT WAS NOTED FRAGMENTS WERE GENERATED BUT WERE EASILY REMOVED WITH NO ADDITIONAL MEDICAL INTERVENTION NEEDED. THERE WAS NO SURGICAL DELAY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231372 ↗
• MalfunctionJan 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, TWO SCREWS WERE NOT ENGAGING WITH THE SCREWDRIVER AND A DRILL BIT BROKE. IT WAS NOTED FRAGMENTS WERE GENERATED BUT WERE EASILY REMOVED WITH NO ADDITIONAL MEDICAL INTERVENTION NEEDED. THERE WAS NO SURGICAL DELAY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231268 ↗
• MalfunctionJan 26, 2024Break; Entrapment of Device; Break; Entrapment of Device

  PATIENT STATUS/ OUTCOME: OPERATED. IMPLANT DATE: SINCE SURGERY, (B)(6) 2024 BROKEN IMPLANTS WERE RETAINED IN THE PATIENT. THERE WERE NO ADDITIONAL INTERVENTIONAL TO REMOVE THE RETAINED FRAGMENTS.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18587388 ↗
• MalfunctionNov 17, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PACKAGE WAS RECEIVED WITH PRODUCT MISSING FROM THE PACKAGING. THERE WAS NO SCREW IN THE PACKAGE. THE PERFORATED END HAD BEEN TORN OFF. THIS REPORT IS FOR ONE (1) 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165404 ↗
• MalfunctionNov 14, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PACKAGE WAS RECEIVED COMPLETELY EMPTY. THE PACKAGE DOES NOT LOOK AS IF IT WAS EVER SEALED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131407 ↗
• MalfunctionNov 14, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PACKAGE WAS RECEIVED COMPLETELY EMPTY. THE PACKAGE DOES NOT LOOK AS IF IT WAS EVER SEALED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131109 ↗
• InjuryJun 13, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING POST-OP PATIENT RETURNED TO CLINIC STATUS POST WRIST FUSION. 2 CORTICAL SCREWS AND 1 LOCKING SCREW WERE PULLING OUT OF THE 3RD PHALANX. SURGEON PLANS TO TAKE PATIENT BACK TO SURGERY. THE PATIENT EXPERIENCED AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THIS REPORT IS FOR ONE (1) 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17119564 ↗
• 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 6 OF 11 FOR (B)(4). THIS REPORT IS FOR A CORTEX SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260152 ↗
• InjuryMay 18, 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 SURGEON WAS REMOVING 2.4MM VA-LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE BECAUSE THE PATIENT HAD TENDON IRRITATION. EVERYTHING WAS REMOVED SUCCESSFULLY. THERE IS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.7 CORTEX SCREW SLF-TPNG T8 SD REC 14. THIS REPORT IS 2 OF 10 (B)(4).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11842151 ↗
• InjuryFeb 7, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING INSERTION THE TIP OF THE STARDRIVE SCREWDRIVER SHAFT BROKE OFF IN THE CORTEX SCREW HEAD. FRAGMENTS WERE GENERATED AND WERE LEFT IN THE CORTEX SCREW HEAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9681930 ↗
• MalfunctionDec 18, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A UNKNOWN BRAND NEW PACKAGE THAT WAS OPENED DOES NOT HAVE A CORTEX SCREW IN IT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8174225 ↗

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