NA 03.037.015Recalls & reported problems
Synthes GmbH · AIMING ARM LOCKING DEVICE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes aiming arm locking device, a surgical instrument used in hip fracture surgery, has 109 malfunction reports, with no deaths and no injuries. Many reports describe parts that would not lock or fit together, bent or deformed components, and instrument pieces breaking apart during sterilization or surgery. 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
- 114
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 10886982070319), received between Mar 2, 2017 and Sep 29, 2026 — classified as 114 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (91 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility91
- Material Deformation16
- Material Twisted/Bent13
- Break9
- Mechanical Jam3
- Defective Device1
- Device Damaged Prior to Use1
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- No Consequences Or Impact To Patient13
- No Patient Involvement7
- Insufficient Information3
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937007 ↗MalfunctionSep 23, 2026Device-Device Incompatibility; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873441 ↗MalfunctionSep 23, 2026Device-Device Incompatibility; Material Deformation
It was reported that TFNA retaining clips are bent and do not fit properly into the slot on the aiming arm. They cannot properly lock the trocar that aims the blade/screw. There was no patient harm and no surgical delay reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869285 ↗MalfunctionSep 23, 2026Device-Device Incompatibility; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869273 ↗MalfunctionSep 23, 2026Device-Device Incompatibility; Material Deformation
It was reported that TFNA retaining clips are bent and do not fit properly into the slot on the aiming arm. They cannot properly lock the trocar that aims the blade/screw. There was no patient harm and no surgical delay reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869269 ↗MalfunctionApr 23, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THERE WAS A FAULTY AIMING ARM ON THEIR TFNA CORE TRAY. THERE'S AN O RING THAT SLIDES INTO THE AIMING ARM WHICH LOCKS THE LAG SCREW ASSEMBLY IN PLACE. THE ASSEMBLY ISN'T LOCKING WHICH IS CAUSING PROBLEMS DURING CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973406 ↗MalfunctionApr 3, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE, THE ITEMS JAMMED TOGETHER. IT APPEARS THAT THEY HAVE BECOME CROSS THREAD INTRA-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780689 ↗MalfunctionFeb 24, 2026Material Deformation
IT WAS REPORTED THAT THE TFNA CLIP FOR JIG DEFORMED FROM MALLET STRIKES DURING SURGICAL CASE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429060 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT MULTIPLE TRAYS HAD COMPONENTS/INSTRUMENTS THAT WERE STARTING TO BREAK APART AND SHEDDING PIECES. DHS INSTRUMENTS WERE NOT IN USEABLE CONDITION IN SPD STERILIZATION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24069021 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT MULTIPLE TRAYS HAD COMPONENTS/INSTRUMENTS THAT WERE STARTING TO BREAK APART AND SHEDDING PIECES. DHS INSTRUMENTS WERE NOT IN USEABLE CONDITION IN SPD STERILIZATION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24069019 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT MULTIPLE TRAYS HAD COMPONENTS/INSTRUMENTS THAT WERE STARTING TO BREAK APART AND SHEDDING PIECES. DHS INSTRUMENTS WERE NOT IN USEABLE CONDITION IN SPD STERILIZATION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24069018 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT MULTIPLE TRAYS HAD COMPONENTS/INSTRUMENTS THAT WERE STARTING TO BREAK APART AND SHEDDING PIECES. DHS INSTRUMENTS WERE NOT IN USEABLE CONDITION IN SPD STERILIZATION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24069017 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT MULTIPLE TRAYS HAD COMPONENTS/INSTRUMENTS THAT WERE STARTING TO BREAK APART AND SHEDDING PIECES. DHS INSTRUMENTS WERE NOT IN USEABLE CONDITION IN SPD STERILIZATION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24069016 ↗MalfunctionJan 13, 2026Break; Material Twisted/Bent
IT WAS REPORTED THAT MULTIPLE TRAYS HAD COMPONENTS/INSTRUMENTS THAT WERE STARTING TO BREAK APART AND SHEDDING PIECES WITH NOT IN USABLE CONDITION DURING THE SPD STERILIZATION PROCESS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059206 ↗MalfunctionDec 16, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE THE INSTRUMENTS WOULD NOT STAY ENGAGED TOGETHER WHILE INSERTING THE HEAD ELEMENT. THE ISSUE WAS EVENTUALLY RESOLVED BY CAREFULLY AVOIDING PRESSURE TO KEEP THE DEVICES CLICKED TOGETHER. THERE WAS NO DELAY IN SURGERY AND NO PATIENT CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822316 ↗MalfunctionSep 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025. THE SLEEVE KEPT GETTING STUCK IN THE AIMING ARM LOCKING DEVICE; DID NOT SLIDE IN PROPERLY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019859 ↗MalfunctionAug 18, 2025Material Deformation; Material Deformation
ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POST OPERATIVE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22829827 ↗MalfunctionJun 24, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
TFNA AIMING ARM AND ALL ASSOCIATED PIECES NEED TO BE REPLACED DUE TO DIFFICULTY AND ABNORMALLY HIGH RESISTANCE EXPERIENCED WHEN INSERTING GUIDE SLEEVES. THEY APPEARED TO GET JAMMED AND STUCK BEFORE FULL INSERTION WAS ACHIEVED. THIS WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22320721 ↗MalfunctionJun 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025 THE NAIL PORTION CAME OUT OF AIMING ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287615 ↗MalfunctionJun 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025 THE NAIL PORTION CAME OUT OF AIMING ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287605 ↗MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES (B)(4) PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21919369 ↗MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21919358 ↗MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21919350 ↗MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21919336 ↗MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21919284 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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