ENDOBUTTONRecalls & reported problems across all models
Smith & Nephew, Inc. · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 247
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls
- 0
We found 21 models of ENDOBUTTON by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 247 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2017 and Jul 8, 2026 — classified as 55 injuries, 192 malfunctions.
The most frequently reported specific device problem is “Break” (105 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 ENDOBUTTON problems
Device problems
- Break105
- Material Separation41
- Flaked19
- Adverse Event Without Identified Device or Use Problem15
- Detachment Of Device Component8
- Detachment of Device or Device Component8
- Insufficient Device Problem Information7
- Material Fragmentation6
Patient problems
- No Known Impact Or Consequence To Patient106
- No Clinical Signs, Symptoms or Conditions90
- Foreign Body In Patient19
- Insufficient Information8
- No Information7
- Device Embedded In Tissue or Plaque3
- No Consequences Or Impact To Patient3
- Unspecified Infection3
ENDOBUTTON models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDOBUTTON 7208678INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT69 reports
- ENDOBUTTON 72202971ACCESSORIES,ARTHROSCOPIC57 reports
- ENDOBUTTON 7207220ORTHOPEDIC MANUAL SURGICAL INSTRUMENT21 reports
- ENDOBUTTON 72200147FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE20 reports
- ENDOBUTTON 72200146FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE17 reports
- ENDOBUTTON 72201594ACCESSORIES,ARTHROSCOPIC17 reports
- ENDOBUTTON 014396PASSER10 reports
- ENDOBUTTON 7210080SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- ENDOBUTTON 72200148SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- ENDOBUTTON 7210153ARTHROSCOPE4 reports
- ENDOBUTTON 72203331FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE3 reports
- ENDOBUTTON 013186FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE3 reports
- ENDOBUTTON 72202799PASSER3 reports
- ENDOBUTTON 72203330FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- ENDOBUTTON 7207323FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- ENDOBUTTON 7210081FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- ENDOBUTTON 72200149SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ENDOBUTTON 72202544GAUGE, DEPTH2 reports
- ENDOBUTTON 7210082FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- ENDOBUTTON 72200150FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- ENDOBUTTON 72202073WASHER, BOLT NUT1 report
Recent ENDOBUTTON adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2026Break
IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY WITH ACL, WHILE INSIDE THE PATIENT, WHEN CREATING THE TUNNEL FOR THE ULTRABUTTON, THE TIP OF ONE (1) FLEXIBLE DRILL BROKE. THE BIT TIP WAS REMOVED USING KELLY FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749791 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY WITH ACL REPAIR, WHILE PASSING A GUIDE WIRE TO CREATE TIBIAL TUNNELS USING THE ULTRABUTTON TECHNIQUE, ONE (1) DRILL TIP PASSING PIN BROKE IN HALF INSIDE THE KNEE JOINT WHERE THE GUIDE WIRE BENT. THE PROCEDURE WAS RESUMED, 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 24724732 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT, DURING A PROCEDURE, THE ENDOBUTTON BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24696123 ↗MalfunctionFeb 23, 2026Break
IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHEN STARTED DRILLING WITH ONE (1) DRILL TIP, THE PATIENT'S BONE WAS VERY HARD AND WHEN FORCING, THE TIP BROKE. IT WAS COMPLETELY REMOVED FROM THE PATIENT WITH A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24416909 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE 4.5MM FLEXIBLE DRILL BROKE INSIDE THE PATIENT. THE PIECES WERE REMOVED FROM INSIDE THE PATIENT USING PLIERS. THE PROCEDURE WAS RESUMED, 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 24268074 ↗MalfunctionDec 31, 2025Flaked; Flaked
IT WAS REPORTED THAT DURING ACL RECONSTRUCTION SURGERY, THE 2.4 MM TROCAR PIN WAS PRODUCING METAL DEBRIS WHILE DRILLING. THE DRILL AND WIRE WERE REMOVED FROM THE JOINT, AND A SHAVER WAS USED TO CLEAR THE INTRA-ARTICULAR SPACE OF THE METAL DEBRIS. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. 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 23933322 ↗MalfunctionDec 30, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHILE DRILLING THROUGH A FEMORAL GUIDE USING THREE (3) UNITS OF A PIN PASSING DRILL TIP, METAL SHAVINGS WERE VISIBLE IN THE JOINT. ALL DEBRIS WAS REMOVED FROM THE PATIENT WITH SUCTION, AND THE PATIENT WAS NOT HARMED. 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 23923470 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHILE INITIATING THE TIBIAL TUNNEL WITH THE GUIDE WIRE, A PIN PASSING DRILL TIP BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED WITH GRASPER FORCEPS. 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 23849624 ↗MalfunctionNov 24, 2025Break; Break
IT WAS REPORTED THAT, DURING A FEMORAL TUNNEL PERFORATION FOR A KNEE ARTHROSCOPY, THE DRILL ENDOSCOPIC CANNULA BROKE IN THE MIDDLE AT THE MOMENT THE SURGEON REVERSED THE DRILL. ONE PART FELL INTO THE CAVITY AND WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS RESUMED, WITH A DELAY OF LESS THAN 30 MINUTES, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23630776 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE DRILL FLEXIBLE ENDOSCOPIC CANNULA (4.5 MM) BROKE INSIDE THE PATIENT¿S KNEE. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE USING TWEEZERS. THE PROCEDURE WAS RESUMED AFTER A 20-MINUTE SURGICAL DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23458056 ↗MalfunctionOct 22, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT BEFORE AN ACL SURGERY, IT WAS NOTICED THAT THE PACKAGING OF THE FLEXIBLE PASSING PIN WAS FOUND TO BE TAMPERED IN. THE PROCEDURE WAS RESUMED AFTER A DELAY OF TEN (10) MINUTES, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23364304 ↗MalfunctionSep 2, 2025Flaked; Flaked
IT WAS REPORTED THAT DURING A PROCEDURE, WHEN DRILLED THROUGH IT WITH THE PIN PASSING DRILL, IT RELEASED METAL SHAVINGS. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22945668 ↗MalfunctionAug 29, 2025Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FLEXIBLE DRILL BROKE, THE BREAK OCCURRED WHEN THE CONDYLE WAS BEING DRILLED. THE FLEXIBLE GUIDE HAD BEEN BENT BY FORCE USED BY THE DOCTOR, THEN THE DRILL BROKE INSIDE THE FEMORAL TUNNEL. THE FRAGMENTS WERE REMOVED BY INTRODUCING FROM THE OUTSIDE TO THE INSIDE FROM THE TIP OF THE GUIDE TOWARDS THE INTERCONDYLAR SPACE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22923451 ↗MalfunctionAug 18, 2025Component Missing; Component Missing
IT WAS REPORTED THAT DURING A PROCEDURE THE ENDOBUTTON ULTRA 20MM BOX WAS OPENED AND THERE WAS NO IMPLANT INSIDE THE BOX, CONTAINING ONLY STICKERS AND A BOOKLET, THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE, THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22825010 ↗MalfunctionAug 11, 2025Component Missing; Component Missing
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE BOX OF THE 20MM ENDOBUTTON ULTRA WAS OPENED, IT WAS NOTICED THAT THERE WAS NO IMPLANT INSIDE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22770769 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- 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
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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