Tools - Screws DVTX-8 NPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842188126048), received between Oct 18, 2024 and Aug 1, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• MalfunctionAug 1, 2025Break; Fracture; Break; Fracture

  A SALES REP REPORTED ON (B)(6) 2025 THAT WHEN THE SURGEON WAS INSERTING THE SECOND TPEG INTO THE VOLAR DISTAL ROW, HE WAS INSTRUCTED TO JUST SNUG THE TPEG AND THE TIP OF THE DVTX-8 NP BROKE OFF. IT WAS REPORTED THAT THERE WAS NO DELAY IN SURGERY BECAUSE THE SURGEON WAS INSTRUCTED TO MOVE ON AND INSERT THE ADDITIONAL SCREWS NEEDED TO FIXATE THE FRACTURE. THE SURGEON THEN WENT BACK AFTER ALL SCREWS WERE IMPLANTED TO TRY TO REMOVE THE DRIVER TIP, WITH NO SUCCESS. THE TIP REMAINS INSITU AND THE SURGEON BELIEVES NO ADDITIONAL HARM IS EXPECTED BECAUSE THE TIP OF THE DRIVER IS FLUSH WITH THE SCREW HEAD. WHILE THE DEVICE IS NOT INTENDED TO COME IN CONTACT WITH THE PATIENT, THE TIP OF THE DEVICE REMAINS IMPLANTED INSIDE OF THE SCREW HEAD.

  Patient problems: Foreign Body In Patient

  MAUDE report 22688397 ↗
• MalfunctionJul 8, 2025Break; Fracture; Break; Fracture

  SALES REP REPORTED ON (B)(6) 2025 THAT A DVTX-8 NP BROKE DURING SURGERY. THE SURGEON STATED THAT DURING THE FINAL TIGHTENING OF THE DISTAL 2.4 MM LOCKING PEGS, THE TIP OF THE SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW. THE TIP OF THE DRIVER HAD COLD WELDED INTO THE SCREW AND THE SURGEON COULD NOT REMOVE IT SO IT REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS PROVIDED ON 08JUL2025 THAT THIS CAUSED A 2-MINUTE DELAY IN SURGERY AND THE SURGEON DOES NOT BELIEVE LEAVING THE BROKEN PIECE IN THE SCREW HEAD WILL CAUSE THE PATIENT ADDITIONAL HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22438755 ↗
• MalfunctionJun 12, 2025Break; Fracture; Break; Fracture

  A SALES REP REPORTED ON 22MAY2025, THAT THE TIP OF THE DVTX-8 NP WAS OVER TORQUED AND THE TIP TWISTED WITH THE NIPPLE COMING OFF AND REMAINING IN THE HEAD OF THE IMPLANTED SCREW. IT WAS REPORTED THAT A SECOND DRIVER WAS USED TO IMPLANT THE REMAINING SCREWS AND SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON REPORTED NO TIME DELAY, HOWEVER, BELIEVED THERE IS POTENTIAL PATIENT IMPACT IF THE MOST DISTAL SCREW WITH BROKEN SCREWDRIVER TIP MAY REQUIRE REVISION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22195908 ↗
• MalfunctionJun 4, 2025Break; Fracture; Break; Fracture

  A SALES REP REPORTED ON (B)(6) 2025 THAT WHEN A SURGEON WAS TIGHTENING THE 2ND MOST RADIAL 2.4 TPEG INTO THE VOLAR FIXED ANGLE PLATE THE TIP OF THE DVTX-8 NP BROKE FLUSH WITH THE SCREW HEAD. IT WAS REPORTED THAT THE BROKEN PIECE OF THE DRIVER TIP WAS UNABLE TO BE REMOVED FROM THE SCREW. NO CURRENT PATIENT IMPACT REPORTED OR TIME DELAY REPORTED BY THE SURGEON. POTENTIAL FOR PATIENT IMPACT IF PROSTHESIS REMOVAL IS REQUIRED IN THE FUTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22142150 ↗
• MalfunctionMay 22, 2025Break; Fracture; Break; Fracture

  A SALES REP REPORTED ON 28APR2025 THAT THE DVTX-8/110 AO NP AND DVTX-8 NP TIPS TWISTED DURING INSERTION OF TPEG SCREWS. ADDITIONAL PICTURES WERE PROVIDED ON 12MAY2025 SHOWING THE TIPS BROKE. THE REP CONFIRMED ON (B)(6) 2025 THAT THE BROKEN TIPS REMAIN IN THE IMPLANTED SCREWS AND THE SURGEON WAS NOT CONCERNED WITH ADVERSE EFFECT TO PATIENT. WHILE THEY TRIED SEVERAL WAYS TO REMOVE THE TIP, THE SURGEON COULDN'T SO FELT SAFE LEAVING THEM INSITU. A PICTURE WAS PROVIDED HOWEVER BOTH DRIVERS HAVE BEEN DISCARDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22073989 ↗
• MalfunctionOct 18, 2024Break; Break

  SALES REP REPORTED ON 30SEP2024 THAT ON (B)(6) 2024, A SURGEON PERFORMED A DISTAL RADIUS ORIF USING THE WS3 SYSTEM. WHEN THE SURGEON WAS IMPLANTING THE DISTAL 2.4MM SCREWS, THE DVTX-8 NP TIP SNAPPED OFF IN THE HEAD OF THE SCREW AND WAS NOT ABLE TO BE RETRIEVED. IT WAS STATED THAT THE DVTX-8 NP CAME IN CONTACT WITH THE SCREW BUT NOT THE PATIENT. IN ADDITION, THERE IS NOTHING TO BE SEEN ON THE X-RAY WITH REGARD TO THIS AS THE TIP OF THE SCREWDRIVER SNAPPED AND WAS RETAINED IN THE RECESS IN THE HEAD OF THE SCREW. THIS CAUSED ABOUT A 5-10 MINUTE DELAY IN SURGERY. THE SURGEON OPTED TO LEAVE THE SCREW IMPLANTED IN SITU BUT THE REMAINDER OF THE DRIVER IS AVAILABLE TO BE RETURNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20482538 ↗