NA 03.037.028Recalls & reported problems
Synthes GmbH · 5MM HEX FLEXIBLE SCREWDRIVER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes hex flexible screwdriver is a surgical tool for placing screws. Its 476 adverse event reports mostly describe the screwdriver breaking, with some reporting bent or unraveled shafts. There are no deaths and 6 injuries. 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
- 486
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 486 adverse event reports that list this exact device (DI 10886982070449), received between Dec 12, 2016 and Sep 30, 2026 — classified as 6 injuries, 480 malfunctions.
The most frequently reported specific device problem is “Break” (419 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
- Break419
- Device-Device Incompatibility41
- Material Twisted/Bent24
- Crack16
- Material Deformation8
- Contamination /Decontamination Problem3
- Material Integrity Problem3
- Mechanical Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions333
- No Consequences Or Impact To Patient78
- No Patient Involvement31
- Insufficient Information28
- No Known Impact Or Consequence To Patient12
- No Code Available8
- Not Applicable2
- Tissue Damage2
Recent adverse event reports
The 25 most recent of 486 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device-Device Incompatibility; Material Twisted/Bent
It was reported that the Driving Cap f/Insertion Handle, Multihole Drill Sleeve, Trocar yell, ScrDriver-hex 5 flex cann, Extract-Instr f/TFNA Helical Blade+Scr, ScrDriver short XL25, ScrDriver w/Quick-Coupl hex 12 short XL2, Hand lrg cann w/Quick-Coupl Hex12, ConnecScr f/TFNA Helical Blade+Scr, and ScrDriver Shaft self-holding L165 f/Star were associated with wear-related and deformation issues. The reported failures included stripped or worn threads that did not engage securely, deformed holes that made guide wire passage difficult, a bent trocar that did not fit the cannula properly, dull screwdriver features that did not seat securely or function properly, and a handpiece that no longer clicked into screwdriver shafts. There was no patient involvement. The complaint devices were retained by the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945962 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931469 ↗MalfunctionSep 22, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859569 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736575 ↗MalfunctionSep 8, 2026Break; Crack; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674972 ↗MalfunctionSep 8, 2026Break; Crack; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674960 ↗MalfunctionSep 8, 2026Break; Crack; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674940 ↗MalfunctionSep 8, 2026Break; Crack; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671482 ↗MalfunctionSep 8, 2026Break; Crack; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671461 ↗MalfunctionSep 8, 2026Break; Crack; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671385 ↗MalfunctionAug 28, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50505030 ↗MalfunctionAug 28, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50496479 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459651 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459605 ↗MalfunctionAug 25, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50437459 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50024327 ↗MalfunctionJul 6, 2026Mechanical Problem
IT WAS REPORTED WHEN OPENING THE EQUIPMENT AND PREPARING THE TABLE, IT IS IDENTIFIED THAT THE FLEXIBLE SCREWDRIVER IS IN POOR CONDITION. WHEN USING THIS SCREWDRIVER IT MAKES ADJUSTING THE ANTI-ROTARY SCREW A LITTLE DIFFICULT BECAUSE IT CAN NOT DO MUCH FORCE AND MANIPULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25716848 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT THE SHAFT OF THE FLEXIBLE SCREWDRIVER BROKE / UNRAVELED. IT WAS NOT NOTICED BY THE SURGEON DURING THE CASE BUT IT WAS NOT DURING THE INSPECTION THE INSTRUMENT AFTER SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25374986 ↗MalfunctionMay 29, 2026Break
IT WAS REPORTED THAT THE SHAFT WAS PARTIALLY BROKEN AT SOME POINT IN THE DECONTAMINATION PROCESS. ITEM WAS USED FOR A SURGERY WITH NO IDENTIFIED ISSUE BUT SALES REP IDENTIFIED THE SHAFT HAD SNAPPED THE NEXT DAY WHEN CHECKING THE SET POST-DECONTAMINATION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333975 ↗MalfunctionMay 28, 2026Break
IT WAS REPORTED THAT THE FLEXIBLE SCREW DRIVER BROKE IN DURING A HIP FRACTURE WHILE IMPLANTING A TFNA NAIL. THE SURGEON WAS TIGHTENING THE SET SCREW IN THE NAIL WITH THE FLEXIBLE SCREW DRIVER AND THE SCREWDRIVER BROKE MID-SHAFT. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT AND PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321578 ↗MalfunctionMay 21, 2026Break
DURING THE PROCEDURE LEFT SUBTROCHANTERIC SURGICAL FIXATION, THE SCREWDRIVER WAS USED TO SIT THE CANNULATED CONNECTING SCREW IN THE NAIL THROUGH THE JIG. WHILE TURNING TO ADVANCE THE LOCKING MECHANISM, THE SCREWDRIVER BROKE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25246947 ↗MalfunctionMay 20, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN DURING THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230766 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED ON (B)(6) 2026, THAT A SCREWDRIVER BROKE INTRA OP DURING A CASE. THERE WAS NO COMPLICATIONS OR DELAY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059147 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT THE FLEXIBLE SCREWDRIVER IS BROKEN. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25050263 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT THE FLEXIBLE SCREWDRIVER IS BROKEN. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048949 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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