RIGIDLOOP 232447Recalls & reported problems
Medos International Sàrl · RIGIDLOOP Adjustable Cortical Implant STANDARD · Class 2 · Implant
Quick summary
This Medos RIGIDLOOP adjustable implant is a fastener used to fix soft tissue during surgery. Of the 612 reports naming it, most describe the suture breaking when it is tightened, sometimes forcing surgeons to switch to a spare device. The reports include 30 injuries and no deaths. 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
- 633
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 633 adverse event reports that list this exact device (DI 10886705024094), received between Jan 16, 2018 and Sep 29, 2026 — classified as 30 injuries, 603 malfunctions.
The most frequently reported specific device problem is “Break” (545 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
- Break545
- Material Frayed21
- Material Split, Cut or Torn21
- Adverse Event Without Identified Device or Use Problem9
- Loosening of Implant Not Related to Bone-Ingrowth9
- Migration8
- Detachment of Device or Device Component7
- Unintended Movement7
Patient problems
- No Clinical Signs, Symptoms or Conditions503
- No Consequences Or Impact To Patient71
- Not Applicable33
- Unspecified Tissue Injury14
- Tissue Damage6
- Discomfort4
- No Code Available4
- Injury2
Recent adverse event reports
The 25 most recent of 633 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938199 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938186 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937668 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937659 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937658 ↗MalfunctionSep 28, 2026Delivered as Unsterile Product; Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923036 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890315 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890304 ↗MalfunctionSep 21, 2026Break; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847261 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829231 ↗MalfunctionSep 17, 2026Device-Device Incompatibility
It was reported that during an arthroscopic anterior cruciate ligament repair procedure. the RGDLOOP ADJUSTABLE STND anchor device could not be deployed. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804312 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793774 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788131 ↗MalfunctionSep 14, 2026Break
It was reported that during Shoulder clavicular joint dislocation surgery, when tightening the RIGIDLOOP suture device, the suture was broken off. Changed another one to continue the surgery, the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.Report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754500 ↗MalfunctionSep 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754499 ↗MalfunctionSep 11, 2026Break
It was reported that during an unspecified surgical procedure, the suture of the adjustable Endobutton failed to withstand the tension applied by the surgeon and snapped. It was reported that a spare device was used to complete the surgery. There were no delays to the surgical procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50731849 ↗MalfunctionSep 11, 2026Break
It was reported that the event occurred during a knee arthroscopy surgery and it involved two devices. Firstly, when the suture of a RIGIDLOOP device was tightened, the suture broke off. Another device was used to complete the surgery. Second, a GRYPHON ORTHOCORD anchor broke off. All the broken parts were removed. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 1 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50729038 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721631 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568828 ↗MalfunctionSep 2, 2026Break
It was reported that during a Cruciate ligament reconstruction surgery, the RGDLOOP ADJUSTABLE STND device suture broke off when tightened. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566961 ↗MalfunctionSep 1, 2026Break
This is report 2 of 2 of (b)(4).It was reported that during an unspecified surgery, 2X RIGIDLOOP devices sutures broke during placement. The procedure was completed without issues. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548483 ↗MalfunctionSep 1, 2026Break
This is report 1 of 2 of (b)(4).It was reported that during an unspecified surgery, 2X RIGIDLOOP devices sutures broke during placement. The procedure was completed without issues. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548476 ↗MalfunctionSep 1, 2026Mechanical Problem; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547734 ↗MalfunctionAug 27, 2026Break
It was reported that during an Anterior Cruciate Ligament Reconstruction surgery the suture on the RGDLOOP ADJUSTABLE STND device broke off when it was tightened. It was not reported if there were any delays to the surgical procedure. It was reported that a spare device was used to complete the surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50477525 ↗MalfunctionAug 27, 2026Break
It was reported that during an Anterior Cruciate Ligament Reconstruction surgery, the suture on the RGDLOOP ADJUSTABLE STND device broke when tightened. It was not reported if there were any delays to the surgical procedure. It was reported that a spare device was used to complete the surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50474389 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
- TWINFIX 72202595Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE446 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.