FAST-FIX 72205676Recalls & reported problems
Smith & Nephew, Inc. · FF FLEX CRVD INSTR · Class 2 · Implant
Quick summary
This Smith & Nephew FAST-FIX suture device is used to repair soft tissue during joint surgery. Most of its 451 reports describe the device coming loose or moving out of place, or the firing mechanism failing to fire. The reports list 9 injuries, no deaths and 442 malfunctions, and no recalls name this device. Reports rose to 218 in the most recent year from 144 in the year before.
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
- 439
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 439 adverse event reports that list this exact device (DI 00885556804704), received between Oct 31, 2022 and Jul 16, 2026 — classified as 9 injuries, 430 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (202 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
- Device Dislodged or Dislocated202
- Failure to Fire102
- Firing Problem98
- Break19
- Premature Activation10
- Failure to Cycle6
- Detachment of Device or Device Component4
- Failure to Advance4
Patient problems
- No Clinical Signs, Symptoms or Conditions432
- Device Embedded In Tissue or Plaque5
- Cartilage damage2
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 439 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25839976 ↗MalfunctionJul 16, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25834517 ↗MalfunctionJul 15, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25834515 ↗MalfunctionJul 15, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25834503 ↗MalfunctionJul 15, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25834492 ↗MalfunctionJul 14, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25812432 ↗MalfunctionJul 14, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25812325 ↗MalfunctionJul 13, 2026Failure to Fire
IT WAS REPORTED THAT DURING A KNEE MENISCECTOMY, THE T2 ANCHOR OF ONE (1) FF FLEX CRVD INSTR NOT DEPLOYED. THE T1 AND T2 WERE REMOVED BY FORCEPS FROM THE PATIENT. THE PATIENT'S TISSUE WAS NOT FRAGILE. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25808049 ↗MalfunctionJul 9, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, WHILE DEPLOYING ONE (1) FAST FIX FLEX CURVED T2 ANCHOR CAME OUT ALONG WITH INSERTER. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25773355 ↗MalfunctionJul 6, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A MENISCAL REPAIR SURGERY, T2 OF ONE (1) FF FLEX CRVD INSTR CAME OUT FROM TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25728486 ↗MalfunctionJul 4, 2026Break
IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE SUTURE OF THE FAST FIX FLEX BROKE. BOTH T IMPLANTS WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN S+N EQUIVALENT BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25709361 ↗MalfunctionJul 4, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A SURGERY, THE T2 OF THE FAST FIX FLEX FELL OFF WHEN DEPLOYED. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25709352 ↗MalfunctionJul 2, 2026Firing Problem
IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, BOTH T1 AND T2 IMPLANTS OF ONE (1) FAST-FIX FLEX WERE DEPLOYED AT THE SAME TIME. BOTH T1 AND T2 IMPLANTS WERE REMOVED FROM THE MENISCUS WITH A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25700437 ↗MalfunctionJul 2, 2026Firing Problem
IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, BOTH T1 AND T2 IMPLANTS OF ONE (1) FAST-FIX FLEX WERE DEPLOYED AT THE SAME TIME. BOTH T1 AND T2 IMPLANTS WERE REMOVED FROM THE MENISCUS WITH A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25700412 ↗MalfunctionJun 30, 2026Firing Problem
IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE FAST-FIX 360 T1 AND T2 DEPLOYED AT THE SAME TIME. BOTH T1 AND T2 WERE REMOVED FROM THE MENISCUS WITH THE HELP OF GRASPER. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SIMILAR S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662383 ↗MalfunctionJun 29, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE T2 IMPLANT OF THE FAST FIX CAME OUT FROM TEAR WHILE PASSING THE KNOT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING THE SAME S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25648615 ↗MalfunctionJun 29, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SECOND IMPLANT OF THE FAST FIX FLEX CAME OUT FROM THE TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING THE SAME S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25648597 ↗MalfunctionJun 28, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A SURGERY, THE T2 OF THE FAST FIX FLEX ANCHOR CAME OUT FROM TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25648516 ↗MalfunctionJun 28, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A SURGERY, THE T2 OF THE FAST FIX FLEX ANCHOR CAME OUT FROM THE MENISCUS TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25648508 ↗MalfunctionJun 28, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A SURGERY, THE SECOND IMPLANT OF THE FAST FIX FLEX ANCHOR CAME OUT FROM TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25648502 ↗MalfunctionJun 28, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE T2 IMPLANT OF THE FAST FIX CAME OUT FROM TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING THE SAME S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25648465 ↗MalfunctionJun 28, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SECOND IMPLANT OF THE FAST FIX FLEX CAME OUT FROM TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING THE SAME S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25648461 ↗MalfunctionJun 25, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A SURGERY, THE SECOND IMPLANT OF THE FAST FIX FLEX ANCHOR CAME OUT FROM TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621222 ↗MalfunctionJun 25, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A SURGERY, THE T2 OF THE FAST FIX FLEX ANCHOR CAME OUT FROM TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621096 ↗MalfunctionJun 21, 2026Failure to Fire
IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE FAST-FIX FLEX T2 DID NOT DEPLOYED FROM THE SHAFT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SIMILAR S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25572645 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
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- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 reports
- ETHIBOND EXCEL X557HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE187 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.