FAST-FIXRecalls & reported problems across all models
Smith & Nephew, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9,554
- Deaths reported
- 1
- Injuries reported
- 2,431
- Recalls
- 0
We found 18 models of FAST-FIX by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 9,554 adverse event reports in the FDA's MAUDE database, received between Mar 30, 2017 and Aug 12, 2026 — classified as 1 death, 2,431 injuries, 7,122 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (3,077 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported FAST-FIX problems
Device problems
- Failure to Fire3,077
- Firing Problem1,933
- Device Dislodged or Dislocated1,431
- Premature Activation794
- Break676
- Physical Resistance/Sticking503
- Activation, Positioning or Separation Problem428
- Failure to Cycle419
Patient problems
- No Clinical Signs, Symptoms or Conditions6,970
- No Known Impact Or Consequence To Patient1,661
- Device Embedded In Tissue or Plaque554
- No Information205
- Foreign Body In Patient144
- No Consequences Or Impact To Patient73
- Injury43
- Insufficient Information35
FAST-FIX models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FAST-FIX 72202468SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 death6,626 reports
- FAST-FIX 72201491SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- FAST-FIX 72205324SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- FAST-FIX 72201494SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 reports
- FAST-FIX 72205325SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE133 reports
- FAST-FIX 72202467SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE119 reports
- FAST-FIX 72205677SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE88 reports
- FAST-FIX 72201492SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE32 reports
- FAST-FIX 72202674ACCESSORIES,ARTHROSCOPIC24 reports
- FAST-FIX 72201495SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE17 reports
- FAST-FIX 72203986SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE7 reports
- FAST-FIX 72201490SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- FAST-FIX 014550ARTHROSCOPE3 reports
- FAST-FIX 72201493SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- FAST-FIX 72202675ACCESSORIES,ARTHROSCOPIC1 report
- FAST-FIX 72201537ACCESSORIES,ARTHROSCOPIC1 report
Recent FAST-FIX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Failure to Cycle; Detachment of Device or Device Component
It was reported that during KNEE ARTHROPLASTY WITH SUTURE surgery, one (1) FAST-FIX 360 STRAIGHT NDL loop failed to deploy when fired. Three unsuccessful attempts were made, resulting in the loop detaching and remaining inside the patient's joint, from where it was subsequently retrieved. The procedure was resumed, without any delay, using an equivalent S+N back-up. No further complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225046 ↗MalfunctionJul 16, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25840319 ↗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 15, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25834487 ↗MalfunctionJul 15, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25833592 ↗MalfunctionJul 15, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832494 ↗MalfunctionJul 15, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25821958 ↗MalfunctionJul 14, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25821816 ↗MalfunctionJul 14, 2026Failure to Fire
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25821557 ↗MalfunctionJul 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25821199 ↗MalfunctionJul 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25821109 ↗
Other Smith & Nephew, Inc. products
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
- TWINFIX48 models · 1,450 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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