NA 03.505.003Recalls & reported problems
Synthes GmbH · SHAFT FOR 90° SCREWDRIVER · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes right-angle screwdriver shaft is a part of a surgical bone screwdriver. Its 142 reports often describe shafts that did not fit other instrument parts, and some describe breaks, bent parts or pieces coming loose. There are no deaths and 3 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
- 154
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 10887587013299), received between Mar 3, 2017 and Sep 29, 2026 — classified as 3 injuries, 151 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (67 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
- Device-Device Incompatibility67
- Break48
- Material Twisted/Bent16
- Detachment of Device or Device Component12
- Device Slipped12
- Contamination /Decontamination Problem8
- Naturally Worn3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Clinical Signs, Symptoms or Conditions105
- No Consequences Or Impact To Patient22
- No Patient Involvement12
- Insufficient Information5
- No Code Available5
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break; Device Slipped
It was reported that no patient was involved. There were little pieces in the 90-degree screwdriver.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934704 ↗MalfunctionSep 29, 2026Break; Device Slipped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934693 ↗MalfunctionSep 28, 2026Break; Device Slipped
It was reported that no patient was involved. There were little pieces in the 90-degree screwdriver.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923443 ↗MalfunctionSep 28, 2026Break; Device Slipped
It was reported that no patient was involved. There were little pieces in the 90-degree screwdriver.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923432 ↗MalfunctionSep 28, 2026Break; Device Slipped
It was reported that no patient was involved. There were little pieces in the 90-degree screwdriver.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923431 ↗MalfunctionSep 28, 2026Break; Device Slipped
It was reported that no patient was involved. There were little pieces in the 90-degree screwdriver.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923425 ↗MalfunctionSep 28, 2026Break; Device Slipped
It was reported that no patient was involved. There were little pieces in the 90-degree screwdriver.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923421 ↗MalfunctionSep 28, 2026Break; Device Slipped
It was reported that no patient was involved. There were little pieces in the 90-degree screwdriver.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923413 ↗MalfunctionSep 28, 2026Break; Device Slipped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923361 ↗MalfunctionSep 28, 2026Break; Device Slipped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923302 ↗MalfunctionSep 24, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890122 ↗MalfunctionSep 15, 2026Break
It was reported that the 90 degree screwdriver shafts are broken and 90 degree blades are broken.
Patient problems: Insufficient Information
MAUDE report 50771545 ↗MalfunctionSep 15, 2026Break
It was reported that the 90 degree screwdriver shafts are broken and 90 degree blades are broken.
Patient problems: Insufficient Information
MAUDE report 50771543 ↗MalfunctionMar 6, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT SHAFT FOR 90 SCREWDRIVER AND MATRIXRIB SCRDRVR BLD SLF-RT 90 SCRWDRVR EXPERIENCED FAILURES IN THE USA. SPECIFICALLY, TWO 90-DEGREE COLLETS AND TWO 90-DEGREE BLADES WERE FOUND BROKEN. THE COLLETS WOULD NOT HOLD THE SCREWDRIVER BLADES, AND THE BLADES WOULD NOT HOLD THE RIB SCREWS AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL CONSEQUENCE ASSOCIATED WITH THIS EVENT, AS THE ISSUE OCCURRED OUTSIDE OF PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24531304 ↗MalfunctionMar 6, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT SHAFT FOR 90 SCREWDRIVER AND MATRIXRIB SCRDRVR BLD SLF-RT 90 SCRWDRVR EXPERIENCED FAILURES IN THE USA. SPECIFICALLY, TWO 90-DEGREE COLLETS AND TWO 90-DEGREE BLADES WERE FOUND BROKEN. THE COLLETS WOULD NOT HOLD THE SCREWDRIVER BLADES, AND THE BLADES WOULD NOT HOLD THE RIB SCREWS AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL CONSEQUENCE ASSOCIATED WITH THIS EVENT, AS THE ISSUE OCCURRED OUTSIDE OF PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24531295 ↗MalfunctionJul 28, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN REASSEMBLING THE 90-DEGREE SCREWDRIVER, THE STAFF TOLD ME THAT THE DRIVE SHAFT WAS BROKEN AND THE BALL BEARINGS WERE FALLING OUT. THEY DISPOSED OF THE BROKEN DRIVE SHAFT BUT KEPT THE OUTER SLEEVE. NOTHING BROKEN WAS NOTICED DURING THE SURGERY. THERE WAS NO ADVERSE EVENT OCCURRED AND NO PATIENT CONSEQUENCES AND NO REVISION SURGERY REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22629773 ↗MalfunctionApr 25, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING PRODUCT TESTING AFTER THE SET CAME THROUGH THE WASH, IT WAS FOUND THAT THE GEARS IN THE GOLD HANDLE OF THE 90 SCREWDRIVER WERE GRINDING ALONG WITH THE INNER SHAFT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21909561 ↗MalfunctionApr 25, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING PRODUCT TESTING AFTER THE SET CAME THROUGH THE WASH, IT WAS FOUND THAT THE GEARS IN THE GOLD HANDLE OF THE 90 SCREWDRIVER WERE GRINDING ALONG WITH THE INNER SHAFT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21909556 ↗MalfunctionOct 15, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) SYSTEM DID NOT WORK PROPERLY IN SURGERY AND WAS STICKING. THE ASSISTANT, WHEN REVIEWING THE PIECES AFTER SURGERY, FOUND THAT THE MOVING PARTS WERE UNLUBRICATED AND WITH DRY BLOOD RESIDUES. AS THE SYSTEM CONTAINS TWO OF EACH ITEM, OTHER DEVICES WERE AVAILABLE FOR USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450800 ↗MalfunctionJun 26, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 90 DEGREE SCREWDRIVER SHAFT BROKE. THE PIECE THAT HOLDS THE BLADE BROKE OFF FROM THE ACTUAL SHAFT. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR A SHAFT FOR 90° SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 19613707 ↗MalfunctionMay 2, 2024Break; Break
IT WAS REPORTED THAT ON UNKNOWN DATE THE 90 DEGREE SCREWDRIVER SHAFT WAS BROKE. THE PIECE THAT HOLDS THE BLADE BROKE OFF FROM THE ACTUAL SHAFT. THERE IS NO MORE INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) SHAFT FOR 90 SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 19232668 ↗MalfunctionMar 25, 2024Break; Break
IT WAS FURTHER REPORTED THAT THE EVENT OCCURRED POSTOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18967759 ↗MalfunctionMar 14, 2024Mechanical Jam; Mechanical Jam
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A SAGITTAL SPLIT RAMUS OSTEOTOMY (SSRO) PERFORMED ON (B)(6) 2023, THE INSTRUMENTS IN QUESTION WERE ASSEMBLED AND ROTATED AS A SCREWDRIVER, HOWEVER THEY DID NOT ROTATE. OTHER INSTRUMENTS WERE ASSEMBLED AS A DRILL, AND THEY WERE USED AS A SCREWDRIVER INSTEAD OF THE INSTRUMENTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT A FOREIGN UNKNOWN SUBSTANCE WAS ON THE FLUTED TIP OF INNER SHAFT. THIS REPORT IS FOR ONE (1) SHAFT FOR 90° SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 18907477 ↗MalfunctionDec 14, 2023Break; Noise, Audible; Break; Noise, Audible
IT WAS REPORTED THAT ON NOVEMBER 22, 2023 THAT, THE SALES REPRESENTATIVE HAVE A 90 DEGREE SCREWDRIVER SHAFT THAT BROKE. IT MAKES A SOUND WHEN ATTACHED TO THE PRO 2 DRIVER AND IS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE ((B)(6)) SHAFT FOR 90 SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18329354 ↗MalfunctionNov 1, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6), 2023, THE BEARING AT THE SHAFT TIP BROKE IN HALF. THE SHAFT IN QUESTION HAD BEEN USED SINCE IT HAD BEEN PURCHASED IN EARLY JULY. THERE WAS AN UNUSUAL NOISE DURING THE SURGERY, BUT SINCE THERE WERE TWO SHAFTS, THE REMAINING ONE WAS USED, AND THE OPERATION CONTINUED. IT WAS DISCOVERED THAT THE SHAFT WAS BROKEN AFTER WASHING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE SHAFT FOR 90° SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18046641 ↗
Other DRIVER, WIRE, AND BONE DRILL, MANUAL devices
- NA 5400007000Stryker Corporation · DRIVER, WIRE, AND BONE DRILL, MANUAL20 reports
- VSP System Mandible Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual13 reports
- NA 03.505.007Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL6 reports
- VSP System Intermediate Surgical Splint3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- VSP System Fibula Cutting Guide with Implant Placement3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- VSP System Fibula Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual5 reports
- VSP System Maxilla Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual4 reports
- NA 03.505.041Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL4 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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