Tools - ScrewsRecalls & reported problems across all models
Trimed, INC. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 7 models of Tools - Screws by Trimed, INC. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2017 and Aug 15, 2025 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Break” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Tools - Screws problems
Device problems
- Break10
- Fracture9
- Corroded4
- Material Integrity Problem3
- Residue After Decontamination2
- Device Inoperable1
- Difficult to Remove1
- Product Quality Problem1
Patient problems
- Foreign Body In Patient10
- No Known Impact Or Consequence To Patient6
- No Patient Involvement3
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Tools - Screws models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tools - Screws PEG-XTNDRORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- Tools - Screws DVTX-8 NPSCREWDRIVER6 reports
- Tools - Screws DVTX-8/110 AO NPSCREWDRIVER4 reports
- Tools - Screws HXDRIVR-2.5 AOSCREWDRIVER2 reports
- Tools - Screws DVHX-2.0/070C AOSCREWDRIVER1 report
- Tools - Screws XTNDRGUIDEORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Tools - Screws GUIDEQ-1.8Guide, surgical, instrument1 report
Recent Tools - Screws adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗MalfunctionSep 7, 2021Product Quality Problem; Product Quality Problem
A TRIMED SALES REPRESENTATIVE REPORTED ON (B)(6) 2021 THAT THE GUIDEQ-1.8 FROM A WRIST FIXATION SET HAD "NOT FOR HUMAN USE" LASER MARKED ON THE BOTTOM OF THE DRILL GUIDE. HE STATED THIS DEVICE WAS FOUND DURING A ROUTINE CHECK OF HIS TRAY AND THAT HE IS UNSURE IF THE DEVICE HAD COME IN CONTACT WITH A PATIENT BUT DOESN'T BELIEVE THIS ISSUE CAUSED ANY ADDITIONAL PATIENT HARM OR DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12433457 ↗MalfunctionMar 20, 2018Material Integrity Problem; Material Integrity Problem
ON (B)(6) 2018, TRIMED WAS NOTIFIED OF A PEG EXTENDER THAT WAS FOUND TO HAVE STARTED TO RUST. THE REP REPORTED THAT THIS FEEDBACK WAS NOT ASSOCIATED WITH A CLINICAL EVENT, AND THERE WAS NO PATIENT INVOLVEMENT. THIS IS THE SEVENTH COMPLAINT OF THIS KIND FOR THIS PART.
Patient problems: No Patient Involvement
MAUDE report 7355989 ↗MalfunctionFeb 9, 2018Material Integrity Problem; Material Integrity Problem
ON (B)(6) 2018, IT WAS REPORTED, BY A TRIMED SALES REP, THAT A PEG-XTNDR IN HIS SET WERE SHOWING RUST AROUND THE SPRING. THE REP REPORTED THAT THIS FEEDBACK WAS NOT ASSOCIATED WITH A CLINICAL EVENT, AND THERE WAS NO PATIENT INVOLVEMENT. THIS IS THE SIXTH COMPLAINT OF THIS KIND FOR THIS TYPE OF PART.
Patient problems: No Patient Involvement
MAUDE report 7261847 ↗MalfunctionFeb 9, 2018Material Integrity Problem; Material Integrity Problem
ON JANUARY 11, 2018, IT WAS REPORTED, BY A TRIMED SALES REP, THAT A PEG-XTNDR IN HIS SET WERE SHOWING RUST AROUND THE SPRING. THE REP REPORTED THAT THIS FEEDBACK WAS NOT ASSOCIATED WITH A CLINICAL EVENT, AND THERE WAS NO PATIENT INVOLVEMENT. THIS IS THE SIXTH COMPLAINT OF THIS KIND FOR THIS TYPE OF PART.
Patient problems: No Patient Involvement
MAUDE report 7261846 ↗MalfunctionDec 20, 2017Corroded; Device Inoperable
DURING VISUAL REVIEW OF MATERIAL BEING SENT TO HOSPITAL, IT WAS DISCOVERED THAT THE SPRING ON A PEG-XTNDR HAD CORRODED. THE NON-CONFORMING PART WAS RETURNED TO THE DISTRIBUTOR, AT WHICH POINT THE DISTRIBUTOR NOTIFIED TRIMED OF THE COMPLAINT ON (B)(6) 2017. THIS INCIDENT OCCURRED IN CHILE. THIS TYPE OF MALFUNCTION FOR THIS PART HAS AN OCCURRENCE RATE OF (B)(4) % BASED ON SALES SINCE 2010.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7136685 ↗
Other Trimed, INC. products
All Trimed, INC. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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