NA 314.280Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982188748), received between Aug 24, 2022 and Nov 12, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 16, 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.

• MalfunctionNov 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT EXTRACTION OF A NON-SYNTHES NAIL ON (B)(6), 2025. SYNTHES EXTRACTION EQUIPMENT WAS USED. THE CONICAL NOZZLE, ALONG WITH THE RETAINING SHEATH AND SLIDING GUIDE, WERE ASSEMBLED TO THE NAIL AND COULD NOT BE DETACHED AFTERWARD. ALL THREE PIECES WERE SENT TOGETHER IN THE KIT. ADDITIONALLY, AN ATTEMPT WAS MADE TO DETACH THESE PIECES, BUT THE COMBINATION WRENCH, WHICH WAS ALSO SENT IN THE KIT, BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536471 ↗
• MalfunctionAug 6, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A DISTAL FEMUR WITH THE SURGEON, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS A SURGICAL DELAY BUT NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728531 ↗
• MalfunctionAug 6, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A DISTAL FEMUR WITH THE SURGEON, THE THREADED LOCKING TOWERS WERE STRIPPED ALONG WITH BOWLING PIN AND OTHER INSTRUMENTS. THE SURGEON WANTS ALL THE HAND DRIVERS REPLACED, LOCKING TOWERS, TROCARS, NEUTRAL SLEEVES, CORTICAL GUIDES BECAUSE THEY ARE EXTREMELY WORN AND DO NOT SNAP INTO THE AIMING ARM EFFECTIVELY. THERE WAS A SURGICAL DELAY BUT NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726647 ↗
• MalfunctionJan 11, 2024Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS, AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED, THAT THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED, DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED, AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) HOLD-SLEEVE LRG F/314.190 314.240 314.26. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18493936 ↗
• MalfunctionJan 9, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE LARGE FRAGMENT SCREW DRIVER HOLDING SLEEVE BROKE WHILE BEING USED FOR. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-LARGE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122317 ↗
• MalfunctionAug 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREW CAPTURE WAS UNABLE TO PICK UP SCREWS. THE SCREW MEASURE WAS MISSING OFF THE SET. THE SCREW CAPTURE WAS TAKEN OFF AND THE SCREWDRIVER WAS USED WITHOUT IT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THIS REPORT IS FOR A HOLDING SLEEVE-LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282121 ↗