TRUESPAN ORTHOCORD 228152Recalls & reported problems
Medos International Sàrl · TRUESPAN Meniscal Repair System PEEK 24 DEGREES ORTHOCORD Violet braided composite suture Size 2-0, (2) PEEK Backstops, and (1) Applier with 24 DEGREES needle Depth Stop: 10mm-20mm Plus or Minus 1mm; Needle: 10mm Plus or Minus .13mm · Class 2 · Implant
All models of TRUESPAN ORTHOCORD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medos TrueSpan OrthoCord meniscal repair system is a knee device that uses a braided suture and small backstops to repair the meniscus. Among the 1,356 reports, some describe the device not firing or its plate not holding to the meniscus during knee surgery, and others describe parts breaking or moving out of place. In several cases another device was used to finish the procedure. The reports include no deaths and 21 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
- 1,398
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,398 adverse event reports that list this exact device (DI 10886705026029), received between Feb 28, 2018 and Sep 30, 2026 — classified as 21 injuries, 1,377 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (518 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 Incompatibility518
- Break204
- Premature Activation159
- Difficult to Advance152
- Migration127
- Detachment of Device or Device Component90
- Material Deformation55
- Positioning Failure46
Patient problems
- No Clinical Signs, Symptoms or Conditions1,174
- No Consequences Or Impact To Patient157
- Not Applicable54
- Unspecified Tissue Injury10
- Foreign Body In Patient9
- Tissue Damage6
- No Known Impact Or Consequence To Patient3
- Injury1
Recent adverse event reports
The 25 most recent of 1,398 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952415 ↗MalfunctionSep 30, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952251 ↗MalfunctionSep 30, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951701 ↗MalfunctionSep 30, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951697 ↗MalfunctionSep 30, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949534 ↗MalfunctionSep 30, 2026Device-Device Incompatibility
It was reported that during an unspecified procedure, the TRUESPAN ORTHOCORD did not fire. Changed to another TRUESPAN ORTHOCORD to continue the surgery but the same problem happened again. 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 50946067 ↗MalfunctionSep 30, 2026Device-Device Incompatibility
It was reported that during an unspecified procedure, the TRUESPAN ORTHOCORD did not fire. Changed to another TRUESPAN ORTHOCORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 2 for PC-(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946065 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938630 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938625 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938624 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938622 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936735 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936734 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936726 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936724 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935348 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
It was reported that during a Meniscal Repair surgery, the TRUESPAN ORTHOCORD did not fire. Changed to another two TRUESPAN ORTHOCORDs to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935345 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935338 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933177 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
This is report 3 of 4 of (b)(4). It was reported that during a Meniscal Repair surgery, the TRUESPAN ORTHOCORD device could not fire again. After the first firing, the device could not fire again. The user changed to another three to continue the surgery, the same problem happened again. 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 50933118 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933058 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
This is report 1 of 4 of (b)(4)It was reported that during a Meniscal Repair surgery, the TRUESPAN ORTHOCORD device could not fire again. After the first firing, the device could not fire again. The user changed to another three to continue the surgery, the same problem happened again. 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 50932993 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932530 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932528 ↗MalfunctionSep 29, 2026Difficult to Advance
This is report 3 of 5 for (b)(4).It was reported that during a Knee Arthroscopy with Meniscal Repair surgery, the second plate from the TRUESPAN 24 DEGREE PEEK device could not fix the meniscus after deployment. Four replacement devices were used; the same problem recurred, resulting in a total of five devices involved. 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 50932527 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 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 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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