Arthrex® AR-1360TR-BCRecalls & reported problems
Arthrex, Inc. · IMPL SYS, MPFL, TIGHTROPE · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867354074), received between Jun 4, 2024 and Sep 10, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714547 ↗MalfunctionJul 19, 2024Break; Break
ON 06/28/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT AN AR-1360TR-BC MPFL IMPLANT SYSTEM, 3.9 BC SWIVELOCK ANCHOR BROKE UPON INSERTION ON A PATIENT WITH HARD BONE. THE BROKEN ANCHOR WAS REMOVED ENTIRELY WITH NO DELAY IN THE CASE. ANOTHER COMPLETE KIT WAS OPENED BECAUSE NO INDIVIDUAL ANCHORS WERE AVAILABLE FOR BACKUP. IT WAS STATED THE SURGEON FOLLOWED THE TECHNIQUE AND WAS NOT CONTENT THAT THE KIT DID NOT CONTAIN A TAP OR AN OPTION FOR A LARGER DRILL. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19784180 ↗MalfunctionJun 4, 2024Unraveled Material; Unraveled Material
ON 08/04/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A AR-1360TR-BC TIGHTROPE DID NOT HAVE ANY FREE TENSIONING ENDS AND WAS TANGLED WITHIN ITSELF WHENEVER THE SCRUB TECH UNFOLDED THE WHITE PACKAGING THAT THE TIGHTROPE WAS CONTAINED IN. THIS WAS DISCOVERED DURING AN UNKNOWN CASE ON (B)(6) 2022, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 08/05/2022, IT WAS REPORTED THAT THIS OCCURRED DURING A MPFL CASE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19457656 ↗
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- 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
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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