ACUMED 80-0728Recalls & reported problems
Acumed LLC · 1.5mm Hex Driver Tip, Locking Groove · Class 1
Quick summary
This Acumed hex driver tip is a surgical screwdriver tip used to lock screws into bone plates. Its 148 reports describe the tip breaking off inside a screw head, sometimes leaving a fragment in the patient. The reports include 6 injuries and no deaths. Reports rose to 142 in the last 12 months from 6 in the 12 months before. No recalls name this device.
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
- 149
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 10806378044311), received between Oct 15, 2025 and Sep 23, 2026 — classified as 6 injuries, 143 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (118 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation118
- Break31
Patient problems
- No Clinical Signs, Symptoms or Conditions143
- Device Embedded In Tissue or Plaque3
- Foreign Body In Patient2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 149 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Break
Patient problems: Insufficient Information
MAUDE report 50875609 ↗InjurySep 15, 2026Material Fragmentation
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50782010 ↗MalfunctionJul 7, 2026Material Fragmentation
IT WAS REPORTED: SNAPPED 1.5 MM HEX DRIVER IN 2.3 MM SCREW IN ACULOC2 PLATE. DRIVER TIP SNAPPED OFF WHEN TURNING SCREW FINAL TIME TO LOCK INTO PLATE, WAS EASILY REMOVED WITH FORCEPS FROM SCREW HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25739749 ↗MalfunctionJun 15, 2026Material Fragmentation
IT WAS REPORTED BY A COMPANY REPRESENTATIVE, A 1.5 DRIVER TIP BROKE OFF IN A 2.3 LOCKING SCREW HEAD. THIS OCCURED DURING A PRIMARY SURGERY WITH NO REPORTED DELAY AND THE PROCEDURE WAS COMPLETED USING ANOTHER DRIVER TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25512999 ↗MalfunctionJun 10, 2026Material Fragmentation
IT WAS REPORTED THAT WHILE TRYING TO IMPLANT A 2.3MM SCREW THE TIP OF THE 1.5 HEX DRIVER TIP BROKE. THERE WAS NO REPORTED DELAY OR ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25463745 ↗InjuryMar 24, 2026Material Fragmentation
IT WAS REPORTED THAT DURING THE PROCEDURE, THEY EXPERIENCED BREAKAGE OF THE SCREWDRIVER TIP. THE TIP OF THE SCREWDRIVER BROKE AND REMAINED STUCK IN THE SCREW, AND REMAINS IN SITU.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24674746 ↗MalfunctionMar 20, 2026Material Fragmentation
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON BROKE TWO DRIVER TIPS FROM ACULOC 2 1.5MM DISTAL SCREWDRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651766 ↗MalfunctionMar 20, 2026Material Fragmentation
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON BROKE TWO DRIVER TIPS FROM ACULOC 2 1.5 MM DISTAL SCREWDRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651737 ↗MalfunctionFeb 18, 2026Material Fragmentation
IT WAS REPORTED THAT, "WE WOULD LIKE TO INFORM YOU OF A NEW INCIDENTS INVOLVING PRODUCT REF. (B)(4) THIS WEEK, WE HAVE RECEIVED FOUR (4) REPORTS FROM THE SAME DISTRIBUTOR REGARDING SCREWDRIVER SHAFT BREAKAGE." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380077 ↗MalfunctionFeb 18, 2026Material Fragmentation
IT WAS REPORTED THAT, "WE WOULD LIKE TO INFORM YOU OF A NEW INCIDENTS INVOLVING PRODUCT REF. (B)(4) THIS WEEK, WE HAVE RECEIVED FOUR (4) REPORTS FROM THE SAME DISTRIBUTOR REGARDING SCREWDRIVER SHAFT BREAKAGE." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380076 ↗MalfunctionFeb 18, 2026Material Fragmentation
IT WAS REPORTED THAT, "WE WOULD LIKE TO INFORM YOU OF A NEW INCIDENTS INVOLVING PRODUCT REF. 80-0728 THIS WEEK, WE HAVE RECEIVED FOUR (4) REPORTS FROM THE SAME DISTRIBUTOR REGARDING SCREWDRIVER SHAFT BREAKAGE." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380057 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370495 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370494 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370493 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370492 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370491 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370473 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370472 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370471 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370470 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370469 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370440 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370439 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370434 ↗MalfunctionFeb 17, 2026Material Fragmentation
A SERIES OF RETROSPECTIVE COMPLAINTS REPORTING DRIVER BREAKAGES WERE REPORTED FROM AN ACUMED DISTRIBUTOR. IT WAS REPORTED THAT, "OVER THE LAST FEW MONTHS, WE NOTICED AN INCREASE OF TIP BREAKING EVENTS FOR THIS INSTRUMENT." THERE HAS BEEN NO REPORTED ADVERSE CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370361 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.