EVOS 71174985Recalls & reported problems
Smith & Nephew, Inc. · T7 LINEAR DRIVER SHAFT WITH AO QC · Class 1
All models of EVOS (190)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew T7 screwdriver shaft is used to tighten and loosen bone screws during surgery. Most of the 57 reports describe the shaft breaking, cracking or chipping, sometimes leaving small fragments in the wound that had to be removed, and occasionally bending or wearing down. 8 reports involved an injury and no deaths were reported. Surgeries were generally finished with a backup screwdriver. No recalls name this device, and reporting has been lower in the past 12 months than the year before, with 3 reports versus 6.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00885556500545), received between May 27, 2019 and Jun 11, 2026 — classified as 8 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Break” (28 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.
Reports received per month
Most reported problems
Device problems
- Break28
- Fracture17
- Material Deformation8
- Material Twisted/Bent7
- Defective Device1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient4
- No Patient Involvement4
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Break
IT WAS REPORTED THAT, DURING A HARDWARE REMOVAL/EXPLANT THAT WAS PLANNED, ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC BROKE DURING A SCREW REMOVAL; SCREWS WERE JUST DIFFICULT TO REMOVE AFTER BEING IN FOR AN EXTENDED PERIOD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25470673 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE TIP OF ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC CHIPPED OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25211737 ↗MalfunctionFeb 9, 2026Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC CHIPPED WHEN THE BIT WAS LOCKING A SCREW. BROKEN PIECE WAS REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293404 ↗MalfunctionOct 20, 2025Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY WHILE TRYING TO LOCK THE DISTAL RADIUS VOLAR PLATE WITH A 2.4 MM SCREW, THE TIP OF ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC BROKE. FRAGMENTS FELL INTO THE WOUND AND WERE REMOVED WITH FORCEPS. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO ADDITIONAL ANESTHETIC WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23335885 ↗MalfunctionAug 19, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE TIP OF THE T7 LINEAR DRIVER SHAFT W/ AO QC BROKE WHILE TIGHTENING THE SCREW. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22837822 ↗MalfunctionApr 17, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC BROKE WHILE PUTTING IN THE SCREW ON POWER. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21862135 ↗MalfunctionMar 27, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A WRIST PROCEDURE, THE T7 LINEAR DRIVER SHAFT W/ AO QC SNAPPED WHILE TIGHTENING. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21715483 ↗MalfunctionMar 11, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC WAS BROKEN. NOTHING FELL OFF IN THE PATIENT. THE TIP OF THE DRIVER BROKE BUT STAYED ATTACHED TO THE DRIVER. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21572504 ↗MalfunctionNov 5, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, BOTH THE TIPS OF A T7 LINEAR DRIVER SHAFT W/ AO QC AND A INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE OFF. ALL PIECES WERE FOUND AND REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20606253 ↗MalfunctionOct 29, 2024Break; Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN THE SURGEON WAS USING THE T7 LINEAR DRIVER SHAFT W/ AO QC, SCREWING IN A SCREW INTO THE PLATE, THE TIP OF THE DRIVER BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20556416 ↗MalfunctionOct 2, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE TOP OF THE T7 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF DURING THE CASE WHILE INSERTING A SCREW. NO PIECES FELL INSIDE THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350248 ↗MalfunctionJun 17, 2024Break; Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC BROKE WHEN THE SURGEON WAS TIGHTENING THE SCREWS. ALL PIECES WERE REMOVED FOLLOWED BY IRRIGATION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19546786 ↗MalfunctionMay 10, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING ORIF WRIST SURGERY, THE TIP OF ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC BROKE WHEN THE SURGEON WAS TIGHTENING SCREW. ALL PIECES OF DRIVER WERE REMOVED WITH NEEDLE DRIVERS AND PROCEEDED TO IRRIGATE AND SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288705 ↗MalfunctionFeb 22, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, THE HEAD OF ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF. THE INSTRUMENT WAS OBSERVED TO BE DAMAGED EXTERNAL FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICES. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18763752 ↗MalfunctionNov 6, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TIBIA PLATEAU PROCEDURE, THE TIP OF A T7 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF WHILE INSERTING A SCREW. ALL BROKEN PIECES ACCOUNTED FOR AND REMOVED USING A SURGICAL INSTRUMENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18078746 ↗MalfunctionAug 29, 2023Break; Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) T7 LINEAR DRIVER SHAFT W/ AO QC BROKE. IT IS UNKNOWN HOW THE TREATMENT WAS COMPLETED AND IF ANY DELAY WAS CAUSED DUE TO THIS INCIDENT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17642011 ↗MalfunctionJul 27, 2023Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DISTAL RADIUS SURGERY, THE TIP OF A T7 LINEAR DRIVER SHAFT W/ AO QC TWISTED AND BROKE. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17410947 ↗MalfunctionApr 16, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING USE, THE TIP OF A T7 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16748743 ↗MalfunctionJan 27, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A WRIST FIXATION SURGERY, THE TIPS OF THE T7 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF WHEN INSERTING A LOCKING SCREW. NO PIECE FELL INTO THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16255839 ↗MalfunctionJan 27, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A WRIST FIXATION SURGERY, THE TIPS OF THE T7 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF WHEN INSERTING A LOCKING SCREW. NO PIECE FELL INTO THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16255727 ↗MalfunctionJul 26, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT TWO T7 LINEAR DRIVER SHAFT W/ AO QC WERE NOTICED TO BE DAMAGE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. PRELIMINARY RESULTS OF INVESTIGATION CONCLUDES THAT THE DEVICE TIP WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15108842 ↗InjuryMar 29, 2022Break; Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, WHILE INSERTING A SCREW, THE TIP OF A T7 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF. THE PIECES WERE RETRIEVED WITH FORCEPS. SURGERY WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SMITH AND NEPHEW BACKUP DEVICE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13945712 ↗InjuryAug 30, 2021Break; Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A T6 HOLDING SLEEVE DID NOT STAY LOCKED AND THE TIP BROKE ON THE T7 LINEAR DRIVER SHAFT W/ AO QC. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12387536 ↗MalfunctionJun 29, 2021Break; Break
IT WAS REPORTED THAT TWO T7 LINEAR DRIVER SHAFT W/ AO QC WAS BROKEN AND BENT. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A DELAY, IF BACKUP WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12082297 ↗MalfunctionJun 29, 2021Break; Break
IT WAS REPORTED THAT TWO T7 LINEAR DRIVER SHAFT W/ AO QC WAS BROKEN, BENT. IT IS UNKNOWN IF THE EVENT HAPPENED DURING A SURGICAL PROCEDURE, IF THERE WAS A SURGICAL DELAY, BACKUP DEVICE AVAILABLE OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12082295 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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