NA 202.872Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982145055), received between Apr 16, 2019 and Jun 13, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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.

• 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) 2.7 CORTEX SCREW SLF-TPNG T8 SD REC 12. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17119562 ↗
• 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 5 OF 11 FOR (B)(4). THIS REPORT IS FOR A CORTEX SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259944 ↗
• 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 CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10536578 ↗
• 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 CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10536473 ↗
• 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 CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10536278 ↗
• MalfunctionApr 16, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) CORTEX SCREW SELF-TAPING WITH T8 STARDRIVE RECESS WAS MISSING FROM THE RECEIVED ORDER OF EIGHT (8) CORTEX SCREWS. ONLY ONE (1) DEVICE OUT OF EIGHT (8) DEVICES WAS MISSING. IT WAS SHIPPED IN A FEDEX EXPRESS ENVELOPE AND WAS NOT SEALED ON THE SIDE. IT WAS SUPPOSED TO BE SEALED ON THE SIDE AS PART OF THE MANUFACTURING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8520503 ↗

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