FOOTPRINT 72203776Recalls & reported problems
Smith & Nephew, Inc. · FAST-FIX 360 REVERSE CURVED NEEDLE, EI · Class 2 · Implant
All models of FOOTPRINT (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554029413), received between Nov 23, 2018 and Mar 14, 2026 — classified as 1 injury, 2 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
- Nonstandard Device1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2026Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE SURGERY, ONE (1) FOOTPRINT ANCHOR BROKE WHILE BEING IMPLANTED. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PATIENT'S STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24600281 ↗InjuryOct 18, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT, AFTER A MEDIAL INSTABILITY PROCEDURE WITH A FOOTPRINT ULR 5.5 PK SUT, SL, ONE PATIENT REQUIRED REVISION SURGERY BECAUSE OF AN IMPLANT FAILURE. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.
Patient problems: Failure of Implant
MAUDE report 12651958 ↗MalfunctionNov 23, 2018Break
IT WAS REPORTED THAT THE METAL INSERTER BROKE. THE ANCHOR WAS SUCCESSFULLY IMPLANTED. BROKEN PIECE WAS REMOVED. NO ISSUES OF ANY KIND WERE REPORTED AND THERE WAS NOT SIGNIFICANT DELAY AND NO PATIENT INJURIES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8100011 ↗
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
- 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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