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NA 04.211.038Recalls & reported problems

Synthes GmbH · 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 38MM · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982119117), received between Jun 12, 2025 and Jan 16, 2026 — classified as 2 malfunctions.

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

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2
  • Device Slipped1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 16, 2026Break; Device Slipped

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY WITH VA-LCP DHP RIGHT. DURING THE FINAL CHECK AFTER FIXING THE PLATE, IT WAS DISCOVERED THAT ONE SCREW WAS LOOSE. THE SURGEON ATTEMPTED TO REMOVE THE 2.7 VA LOCKING SCREW 38MM, BUT IT BROKE OFF AT THE SCREW HEAD, MAKING IT IMPOSSIBLE TO REMOVE THE SCREW WITH A SCREWDRIVER. THE SURGEON WAS ABLE TO REMOVE THE BROKEN SCREW BY GRASPING AND ROTATING THE THREADED PORTION WITH FINE-TIPPED FORCEPS FROM THE GAP BETWEEN THE PLATE AND THE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24093598 ↗
  • MalfunctionJun 12, 2025Break; Break

    IT WAS REPORTED THE SURGEON NOTED THAT SOME METAL MATERIAL SHAVINGS CAME OUT WHEN HE INSERTED THE SCREWS INTRAOPERATIVELY. SURGERY DATE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO KNOWN PATIENT CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22194255 ↗

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

Sources and updates

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