CoNextions TR Tendon Repair System-Combo Kit FA0001Recalls & reported problems
Conextions Medical Inc · The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00861445000303), received between Sep 1, 2023 and Sep 27, 2024 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Rupture2
- Muscle/Tendon Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT SUFFERED A LACERATION OF THE FLEXOR POLLICIS LONGUS (FPL) TENDON OF THE RIGHT THUMB. THE TENDON WAS SURGICALLY REPAIRED USING A TWO STRAND SUTURE REPAIR AND A CONEXTIONS TR TENDON REPAIR IMPLANT. APPROXIMATELY A WEEK AFTER THE PROCEDURE, THE PATIENT REPORTED AN INABILITY TO MOVE THE THUMB. THE SURGEON SURGICALLY EXPLORED THE AREA AND FOUND THE REPAIR HAD RUPTURED WITH THE CONEXTIONS TR IMPLANT HAVING PULLLED OUT OF THE DISTAL SIDE OF THE REPAIR. THE CONEXTIONS TR IMPLANT WAS FULLY REMOVED AND THE TENDON WAS REAPPROXIMATED USING SUTURE.
Patient problems: Rupture
MAUDE report 20321146 ↗InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT SUFFERED A LACERATION TO THE EXTENSOR POLLICIS LONGUS (EPL) TENDON OF THE LEFT THUMB. THE TENDON WAS SURGICALLY REPAIRED WITH A CONEXTOINS TR TENDON REPAIR IMPLANT. 14 DAYS POST-OPERATIVE THE PATIENT WAS MOVING HEAVY FURNITURE, FELT A "POP" AND WAS NO LONGER ABLE TO EXTEND THEIR THUMB. THE SURGEON SURGICALLY EXPLORED THE AREA AND FOUND THE REPAIR HAD RUPTURED. THE CONEXTIONS TR TENDON REPAIR IMPLANT WAS FULLY REMOVED AND THE TENDON, AND A EIP TO EPL TENDON TRANSFER WAS PERFORMED TO ADDRESS THE ISSUE WITH SUTURE USED TO APPROXIMATE THE TWO TENDONS TOGETHER.
Patient problems: Muscle/Tendon Damage; Rupture
MAUDE report 17671543 ↗
Other Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile devices
- ETHICON M660GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE102 reports
- ETHICON M650GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE68 reports
- ETHIBOND EXCEL X425HEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 recall12 reports
- Steel 88862224-49Covidien LP · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 recall3 reports
- ETHICON M655GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE46 reports
- ETHIBOND EXCEL MB66GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE42 reports
- Steel 88862424-89Covidien LP · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE39 reports
- ETHICON M649GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE36 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.
How reports and recalls are matched · Editorial policy · Report an error on this page