FAST-FIX 72202468Recalls & reported problems
Smith & Nephew, Inc. · FAST-FIX 360 CURVED MENISCAL REPAIR SYSTEM · Class 2 · Implant
Quick summary
This Smith & Nephew FAST-FIX curved repair system is used to attach stitches to torn knee cartilage. Of its 6,696 reports, 1 describes a death and 1,662 describe injuries. Many describe the device failing to fire or firing improperly, along with parts breaking or sticking, and some mention devices dislodging or activating too early. No recalls name this device.
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
- 6,626
- Deaths reported
- 1
- Injuries reported
- 1,662
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6,626 adverse event reports that list this exact device (DI 00885554023077), received between May 17, 2017 and Jul 16, 2026 — classified as 1 death, 1,662 injuries, 4,963 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (2,285 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
- Failure to Fire2,285
- Firing Problem1,338
- Device Dislodged or Dislocated859
- Premature Activation627
- Break461
- Physical Resistance/Sticking433
- Failure to Cycle376
- Activation, Positioning or Separation Problem343
Patient problems
- No Clinical Signs, Symptoms or Conditions4,818
- No Known Impact Or Consequence To Patient1,185
- Device Embedded In Tissue or Plaque416
- No Information136
- Foreign Body In Patient112
- No Consequences Or Impact To Patient50
- Injury33
- Cartilage damage17
Recent adverse event reports
The 25 most recent of 6,626 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 25840319 ↗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 ↗MalfunctionJul 14, 2026Firing Problem
IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, BOTH TS OF TWO (2) FAST-FIX 360 CURVED NDL DELIVERY SYS FELL OFF ONCE THE DEVICE WAS DEPLOYED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP PRODUCT. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25812171 ↗MalfunctionJul 13, 2026Component Missing
IT WAS REPORTED THAT, DURING A KNEE JOINT MENISCUS POSTERIOR HORN SURGERY, ONE (1) FAST-FIX 360 CURVED NDL DELIVERY SYS WAS ONLY WITH A T-ANCHOR. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING A COMPETITOR DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25808098 ↗MalfunctionJul 13, 2026Failure to Fire
IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE FAST FIX'S T2 IMPLANT COULD NOT BE DEPLOYED. THE T1 WAS SUCCESSFULLY REMOVED BY CUT OPEN AND REMOVE. 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 25807992 ↗MalfunctionJul 13, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A MENICUS REPAIR SURGERY, TWO (2) FAST-FIX 360 CURVED NDL DELIVERY SYS IMPLANTS DID NOT DEPLOY AND CAME OUT OF THE MENISCUS. T1 WAS DEPLOYED, BUT T2 CAME OUT OF THE MENISCUS. T1 WAS REMOVED FROM THE MENISCUS WITH THE HELP OF A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A LESS THAN OR EQUAL TO 30MINS, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL ANESTHESIA WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25807962 ↗MalfunctionJul 13, 2026Failure to Fire
IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE FAST FIX'S T2 IMPLANT COULD NOT BE DEPLOYED. THE T1 WAS CUT OPEN AND REMOVED. 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 25804436 ↗MalfunctionJul 13, 2026Failure to Fire
IT WAS REPORTED THAT, DURING A MENISCAL REPAIR, THE T2 IMPLANT OF THREE (3) FAST-FIX 360 CURVED NDL DELIVERY SYS HAD A MISFIRE. THE T1 IMPLANTS WERE SUCCESSFULLY REMOVED WITH A PULLBACK ON THE SUTURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25803307 ↗MalfunctionJul 13, 2026Failure to Fire
IT WAS REPORTED THAT, DURING A MENISCAL REPAIR, THE T2 IMPLANT OF ONE (1) FAST-FIX 360 CURVED NDL DELIVERY SYS HAD A MISFIRE. THE T1 IMPLANT WAS SUCCESSFULLY REMOVED WITH A PULLBACK ON THE SUTURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25803215 ↗MalfunctionJul 12, 2026Premature Activation
IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, WHILE INTERNAL TO PATIENT, THE T2 IMPLANT OF ONE (1) FAST-FIX 360 FELL OFF FROM THE INSERTER DURING USE. BOTH T IMPLANTS WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. 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 25791430 ↗MalfunctionJul 10, 2026Failure to Fire
IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, ONE (1) FAST-FIX 360 CURVED NDL DELIVERY SYS HAD A T2 DEPLOYMENT FAILURE. T1 WAS SUCCESSFULLY REMOVED WITH PLANNING TOOLS AND SUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785258 ↗MalfunctionJul 9, 2026Firing Problem
IT WAS REPORTED THAT DURING A MENISCUS REPAIR, ONE (1) FAST-FIX 360 CURVED NDL DELIVERY SYS HAD ISSUES WITH THE DEPLOYMENT OF THE SECOND IMPLANT, THE DEPLOYMENT REQUIRES EXCESSIVE FORCE, SOME DEPLOYED AFTER SEVERAL ATTEMPTS AND OTHERS DID NOT AND SLIP OUT OF THE MENISCUS. THE PROCEDURE WAS RESUMED, WITH NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25774329 ↗MalfunctionJul 9, 2026Firing Problem
IT WAS REPORTED THAT DURING MENISCUS REPAIR, ONE (1) AST-FIX 360 CURVED NDL DELIVERY SYS HAD BOTH T'S PULLED OUT WHILE THE PROCESS OF FINAL DEPLOYMENT. THE PROCEDURE WAS RESUMED, WITH NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25774124 ↗MalfunctionJul 9, 2026Failure to Fire
IT WAS REPORTED THAT, DURING A MENISCUS SUTURE SURGERY, T2 OF ONE (1) FAST-FIX 360 CURVED NDL DELIVERY SYS FAILED TO DEPLOY. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP; HOWEVER, IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25773524 ↗MalfunctionJul 7, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE T2 ANCHOR OF THREE (3) FAST-FIX 360 CAME OUT OF THE MENISCUS AFTER THE T1 HAD ALREADY BEEN DEPLOYED. THE T1 WAS REMOVED FROM THE MENISCUS WITH THE HELP OF A GRASPER. THE PROCEDURE WAS RESUMED, WITH NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25742844 ↗MalfunctionJul 7, 2026Firing Problem
IT WAS REPORTED THAT DURING A PROCEDURE, BOTH SUTURES OF FOUR (4) FAST FIX CAME OUT AT THE MOMENT THEY WERE TRIGGERED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25742592 ↗MalfunctionJul 7, 2026Failure to Fire
IT WAS REPORTED THAT DURING A PROCEDURE, THE T2 IMPLANT OF THE FAST FIX DID NOT DEPLOY PROPERLY INTO THE MENISCUS AS THERE WERE NO SPRING BACK MECHANISM DURING THE DEPLOYMENT. THE ANCHOR FOR T2 WAS STILL ON THE FAST FIX SHAFT. THE SURGEON BELIEVED THE MENISCUS QUALITY WAS GOOD AND THAT THE ISSUE WAS RELATED TO IMPLANT DEPLOYMENT AND ENGAGEMENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 25728626 ↗MalfunctionJul 6, 2026Failure to Fire
IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE T2 IMPLANT OF ONE (1) FAST-FIX 360 FAILED TO DEPLOY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25728369 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
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- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 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.