Arthrex® AR-1747-BRecalls & reported problems
Arthrex, Inc. · TRIMANO Fortis Reusable Leg Holder · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867290808), received between Aug 10, 2023 and Aug 14, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Material Twisted/Bent3
- Defective Device1
- Fitting Problem1
- Loose or Intermittent Connection1
- Material Separation1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255616 ↗MalfunctionDec 1, 2025Break; Break
ON 11/06/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER HAD A RIVET BREAK AND WAS BENT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23679604 ↗MalfunctionOct 15, 2025Break; Break
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-07085902 THAT AN AR-1747-B TRIMANO LEG HOLDER HAD A BROKEN SCREW DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302582 ↗MalfunctionOct 15, 2025Break; Break
ON 10/06/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4)THAT AN AR-1747-B TRIMANO LEG HOLDER HAD A BROKEN SCREW DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301684 ↗MalfunctionDec 12, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER HAS RIBS THAT ARE COMING OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20914045 ↗MalfunctionMay 28, 2024Fitting Problem; Fitting Problem
ON 4/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER WAS NOT CLICKING TOGETHER WHEN TRYING TO USE DURING A CASE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19404571 ↗MalfunctionMay 21, 2024Defective Device; Defective Device
IT WAS REPORTED THAT THE RIVETS ON THE AR-1747-B ARE LOOSENING AT THE TRIMANO ATTACHMENT SITE. NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 19358624 ↗MalfunctionMay 14, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ON 04/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER HAD A SCREW POP LOOSE AND CAUSED IT TO WOBBLE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19316198 ↗MalfunctionFeb 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 01/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1747-B TRIMANO KNEE HOLDER WOULD NOT CLICK IN AND WOULD GET STUCK. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. 10 MINUTE DELAY IN CASE. CASE COMPLETED WITH NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18688607 ↗MalfunctionSep 7, 2023Material Twisted/Bent; Material Twisted/Bent
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1747-B REUSABLE LEG HOLDER WAS BENT DURING THE CASE. THE ISSUE WAS DISCOVERED AFTER THE CASE, AND THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17697690 ↗MalfunctionAug 10, 2023Material Twisted/Bent; Material Twisted/Bent
ON 7/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER WAS BENT DURING USE IN THE CASE. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17497707 ↗MalfunctionAug 10, 2023Material Twisted/Bent; Material Twisted/Bent
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER WAS BENT DURING USE IN THE CASE. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17497565 ↗
Other TABLE AND ATTACHMENTS, OPERATING-ROOM devices
- Arthrex® AR-1644Arthrex, Inc. · Table and attachments, operating-room5 reports
- Arthrex® AR-1560-02Arthrex, Inc. · TABLE AND ATTACHMENTS, OPERATING-ROOM4 reports
- Leg holder 100380A0MAQUET GmbH · TABLE AND ATTACHMENTS, OPERATING-ROOM4 reports
- Arthrex® AR-1500Arthrex, Inc. · TABLE AND ATTACHMENTS, OPERATING-ROOM3 reports
- Pair of leg plates 113373BCMAQUET GmbH · TABLE AND ATTACHMENTS, OPERATING-ROOM3 reports
- Traction boot, adult 10018800MAQUET GmbH · TABLE AND ATTACHMENTS, OPERATING-ROOM2 reports
- Leg holder 100165A0MAQUET GmbH · TABLE AND ATTACHMENTS, OPERATING-ROOM2 reports
- Arthrex® AR-1560Arthrex, Inc. · TABLE AND ATTACHMENTS, OPERATING-ROOM2 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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