Tools - Screws DVTX-8/110 AO NPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842188126055), received between Dec 4, 2024 and Aug 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Break; Fracture; Break; Fracture

  SALES REP REPORTED ON (B)(6) 2025 THAT IN A DISTAL RADIUS CASE WITH A SURGEON, THEY HAD A DVTX-8/110 AO NP BREAK. IT WAS REPORTED THAT THIS OCCURRED AT THE END OF THE CASE SO IT DIDN'T CHANGE THE OUTCOME OF THE SURGERY. THE REP CONFIRMED THE REMAINING PIECE OF THE BROKEN TIP WAS LEFT IN THE HEAD OF THE SCREW AS IT COULD NOT BE REMOVED SO IT REMAINS IMPLANTED. THIS CAUSED LESS THAN A 5-MINUTE DELAY IN SURGERY AND POTENTIAL PATIENT HARM IS UNKNOWN. THE DEVICE WAS DISCARDED AT THE FACILITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22819471 ↗
• MalfunctionFeb 18, 2025Break; Fracture; Break; Fracture

  (B)(6) REPORTED ON (B)(6) 2025 THAT THE DVTX-8/110 AO NP TIP SNAPPED OFF INSIDE HEAD OF A TPEG. IT WAS REPORTED THAT THE DEVICE WAS NOT BEING USED UNDER POWER AS THE SURGEON WAS USING THE HNDL-QUICK BY HAND, THE BROKEN TIP WAS NOT ABLE TO BE REMOVED AND THE SURGEON REPORTED THE SCREW WAS ADEQUATELY LOCKED AND OPTED TO LEAVE IMPLANT WITH SCREWDRIVER TIP INSITU. THE SURGEON REPORTED NO TIME DELAY, HOWEVER, BELIEVED THERE IS POTENTIAL PATIENT IMPACT IF THE MOST DISTAL SCREW WITH BROKEN SCREWDRIVER TIP REQUIRES REVISION. A PICTURE WAS PROVIDED, NO X-RAYS WERE PROVIDED BUT THE REMAINDER OF THE DEVICE IS AVAILABLE TO BE RETURNED. (B)(6) STATED ON (B)(6) 2025 THAT THE DEVICE IS NO LONGER AVAILABLE TO BE RETURNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21405891 ↗
• MalfunctionFeb 13, 2025Break; Fracture; Break; Fracture

  SALES REP REPORTED ON (B)(6)2025 THAT THE DVTX-8/110 AO NP TIP SNAPPED OFF INSIDE HEAD OF DISTAL TPEG. IT WAS REPORTED THAT THE DEVICE WAS NOT BEING USED UNDER POWER AS THE SURGEON WAS USING THE HNDL-QUICK BY HAND, THE BROKEN TIP WAS NOT ABLE TO BE REMOVED AND THE SURGEON REPORTED THE SCREW WAS ADEQUATELY LOCKED AND OPTED TO LEAVE IMPLANT WITH SCREWDRIVER TIP INSITU. THE SURGEON REPORTED NO TIME DELAY, HOWEVER, BELIEVED THERE IS POTENTIAL PATIENT IMPACT IF THE MOST DISTAL SCREW WITH BROKEN SCREWDRIVER TIP REQUIRES REVISION. A PICTURE WAS PROVIDED, NO X-RAYS WERE PROVIDED BUT THE REMAINDER OF THE DEVICE IS AVAILABLE TO BE RETURNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21375889 ↗
• MalfunctionDec 4, 2024Break; Fracture; Break; Fracture

  SALES REP REPORTED ON 04NOV2024 TO TRIMED, INC. THAT WHEN THE SURGEON IN (B)(6) WAS TIGHTENING THE 2.4MM TPEGS INTO THE DISTAL MOST ULNA HOLE OF THE VOLAR PLATE ON (B)(6) 2024, THE TIP OF THE DVTX-8/110 AO NP SCREWDRIVER SNAPPED FLUSH IN THE HEAD OF THE SCREW. IT WAS REPORTED THAT THE DEVICE WAS NOT BEING USED UNDER POWER, THE BROKEN TIP WAS NOT ABLE TO BE REMOVED AND THE SURGEON REPORTED THE SCREW WAS ADEQUATELY LOCKED AND OPTED TO LEAVE IMPLANT WITH SCREWDRIVER TIP INSITU. THE SURGEON REPORTED NO TIME DELAY, HOWEVER, BELIEVED THERE IS POTENTIAL PATIENT IMPACT IF THE MOST ULNAR SCREW WITH BROKEN SCREWDRIVER TIP REQUIRES REVISION. NO PICTURES OR X-RAYS WERE PROVIDED BUT THE REMAINDER OF THE DEVICE IS AVAILABLE TO BE RETURNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20845878 ↗