TRIGENRecalls & reported problems across all models
Smith & Nephew, Inc. · 381 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
5 open recalls name at least one TRIGEN model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3,599
- Deaths reported
- 2
- Injuries reported
- 966
- Recalls
- 5
We found 381 models of TRIGEN by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 3,599 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2017 and Jul 3, 2026 — classified as 2 deaths, 966 injuries, 2,631 malfunctions.
The most frequently reported specific device problem is “Break” (1,561 reports).
5 FDA recall records name at least one of these models by its device identifier, 5 still open.
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
TRIGEN recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 16, 2026Open, Classified
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.
Z-2456-2026 · Root cause: Process control · Recall details · FDA record ↗
- Mar 18, 2025Open, Classified
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Z-1806-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jul 24, 2023Open, Classified
A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
Z-2444-2023 · Root cause: Process control · Recall details · FDA record ↗
- Jul 24, 2023Open, Classified
A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
Z-2443-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2022Open, Classified
Right nails were anodized, marked, and labelled as left nails and vice versa
Z-1133-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported TRIGEN problems
Device problems
- Break1,561
- Fracture668
- Adverse Event Without Identified Device or Use Problem179
- Material Deformation170
- Connection Problem135
- Material Twisted/Bent131
- Crack87
- Failure to Align79
Patient problems
- No Clinical Signs, Symptoms or Conditions2,344
- No Known Impact Or Consequence To Patient298
- No Consequences Or Impact To Patient239
- Failure of Implant187
- No Patient Involvement143
- Injury112
- Pain73
- Foreign Body In Patient72
TRIGEN models
381 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- TRIGEN 71674079TAPE, MEASURING, RULERS AND CALIPERS454 reports
- TRIGEN 71674067ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- TRIGEN 71674001ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES128 reports
- TRIGEN 71674068ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES128 reports
- TRIGEN 71118200PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- TRIGEN 71674076Prosthesis, hip, femoral component, cemented, metal111 reports
- TRIGEN 71647336ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 recalls1 report
- TRIGEN 71674570ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES95 reports
- TRIGEN 71674084ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES94 reports
- TRIGEN 71631066ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES87 reports
- TRIGEN 71674002ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES78 reports
- TRIGEN 71674532ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES75 reports
- TRIGEN 71674070ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES71 reports
- TRIGEN 71631626PLATE, FIXATION, BONE60 reports
- TRIGEN 71631068ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES55 reports
- TRIGEN 71642690ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall3 reports
- TRIGEN 71631123PLATE, FIXATION, BONE53 reports
- TRIGEN 71676627NAIL, FIXATION, BONE1 recall2 reports
- TRIGEN 71760816ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall2 reports
- TRIGEN 71674003ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES51 reports
- TRIGEN 71676628NAIL, FIXATION, BONE1 recall0 reports
- TRIGEN 71631440ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES50 reports
- TRIGEN 71674035SCREWDRIVER43 reports
- TRIGEN 71674080ORTHOPEDIC MANUAL SURGICAL INSTRUMENT43 reports
- TRIGEN 71674087ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES43 reports
- TRIGEN 71692801Orthopedic stereotaxic instrument41 reports
- TRIGEN 71674075ORTHOPEDIC MANUAL SURGICAL INSTRUMENT36 reports
- TRIGEN 71631121PLATE, FIXATION, BONE33 reports
- TRIGEN 71631070ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES30 reports
- TRIGEN 71675383NAIL, FIXATION, BONE29 reports
- TRIGEN 71674077ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES29 reports
- TRIGEN 71631116Prosthesis, hip, femoral component, cemented, metal26 reports
- TRIGEN 71654524ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES26 reports
- TRIGEN 71674078ORTHOPEDIC MANUAL SURGICAL INSTRUMENT25 reports
- TRIGEN 71654501ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES24 reports
- TRIGEN 71631140ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES21 reports
- TRIGEN 71751140ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES20 reports
- TRIGEN 71677100NAIL, FIXATION, BONE20 reports
- TRIGEN 71675385NAIL, FIXATION, BONE18 reports
- TRIGEN 71674576INSTRUMENT, BENDING OR CONTOURING18 reports
- TRIGEN 71677095NAIL, FIXATION, BONE18 reports
- TRIGEN 71631436ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES17 reports
- TRIGEN 71674066ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES17 reports
- TRIGEN 71654502ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES17 reports
- TRIGEN 71631021ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES17 reports
- TRIGEN 71674523ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES16 reports
- TRIGEN 71631189APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT16 reports
- TRIGEN 71675202NAIL, FIXATION, BONE15 reports
- TRIGEN 71674041ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES14 reports
- TRIGEN 71631448ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES13 reports
- TRIGEN 71631444ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES13 reports
- TRIGEN 71674540ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES13 reports
- TRIGEN 71118226Prosthesis, hip, femoral component, cemented, metal13 reports
- TRIGEN 71631161DRIVER, PROSTHESIS13 reports
- TRIGEN 71674086ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES13 reports
- TRIGEN 71675081ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES13 reports
- TRIGEN 71645030ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- TRIGEN 71701016LROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- TRIGEN 71631022ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- TRIGEN 71645035ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- TRIGEN 71631172APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT11 reports
- TRIGEN 71674071ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- TRIGEN 71674081ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- TRIGEN 71677090NAIL, FIXATION, BONE11 reports
- TRIGEN 71675384NAIL, FIXATION, BONE10 reports
- TRIGEN 71645040ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES10 reports
- TRIGEN 71674558ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES10 reports
- TRIGEN 71118231Prosthesis, hip, femoral component, cemented, metal10 reports
- TRIGEN 71645027ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- TRIGEN 71118224Prosthesis, hip, femoral component, cemented, metal9 reports
- TRIGEN 71751131ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- TRIGEN 71751133ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- TRIGEN 71631024ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- TRIGEN 71631035PLATE, FIXATION, BONE9 reports
- TRIGEN 71692814Orthopedic stereotaxic instrument9 reports
- TRIGEN 71692802Orthopedic stereotaxic instrument9 reports
- TRIGEN 71675501NAIL, FIXATION, BONE8 reports
- TRIGEN 71701016RROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- TRIGEN 71675208NAIL, FIXATION, BONE8 reports
- TRIGEN 71677085NAIL, FIXATION, BONE8 reports
- TRIGEN 71692815Orthopedic stereotaxic instrument8 reports
- TRIGEN 71692809Orthopedic stereotaxic instrument8 reports
- TRIGEN 71654554ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- TRIGEN 71645045ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- TRIGEN 71675386NAIL, FIXATION, BONE7 reports
- Trigen 71935419INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT7 reports
- TRIGEN 71631110PLATE, FIXATION, BONE7 reports
- TRIGEN 71129402TRAY, SURGICAL, INSTRUMENT7 reports
- TRIGEN 71677105NAIL, FIXATION, BONE7 reports
- TRIGEN 71654506ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- TRIGEN 71631451ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TRIGEN 71692852Orthopedic stereotaxic instrument6 reports
- TRIGEN 71118236Prosthesis, hip, femoral component, cemented, metal6 reports
- TRIGEN 71631124ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TRIGEN 71631160APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT6 reports
- TRIGEN 71118228Prosthesis, hip, femoral component, cemented, metal6 reports
- TRIGEN 71701020LROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TRIGEN 71701120LROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TRIGEN 71700004ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TRIGEN 71674074PIN, FIXATION, THREADED6 reports
Recent TRIGEN adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2026Failure to Align
IT WAS REPORTED THAT, DURING AN INTERTAN NAIL SURGERY, THE DISTAL 5.0MM TRIGEN SCREW WAS MISSING THE NAIL. THE JIG WAS NOT PROPERLY ALIGNED WITH THE NAIL. 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 25703831 ↗MalfunctionJun 15, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT, DURING A INTERNAL FIXATION SURGERY, ONE (1) T-HANDLE WAS MISSING. THEREFORE, THE PROXIMAL PLUG COULD NOT BE PLACED. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30MIN, USING A COMPETITOR 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 25498106 ↗MalfunctionJun 15, 2026Fracture
IT WAS REPORTED THAT, DURING A ORIF SURGERY, THE THREADS OF ONE (1) RULER CHIPPED OFF. 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 25498087 ↗MalfunctionJun 12, 2026Failure to Align; Material Twisted/Bent
IT WAS REPORTED THAT, DURING AN INTERTROCHANTERIC FRACTURE SURGERY, USING TWO (2) 4.0MM DRILL SLEEVE THAT WERE BENT, THE DRILL AND SCREW WERE FREQUENTLY OFF TRAJECTORY AND MISSING THE SCREW HOLE IN THE NAIL THROUGH THE GUIDE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE TO A PERFECT CIRCLE TECHNIQUE. NO ADDITIONAL INCISIONS OR REMOVAL OF BONE. 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 25485269 ↗MalfunctionJun 12, 2026Failure to Align
IT WAS REPORTED THAT, DURING AN INTERTROCHANTERIC FRACTURE SURGERY, USING TWO (2) 9MM DRILL SLEEVE THAT WERE BENT, THE DRILL AND SCREW WERE FREQUENTLY OFF TRAJECTORY AND MISSING THE SCREW HOLE IN THE NAIL THROUGH THE GUIDE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE TO A PERFECT CIRCLE TECHNIQUE. NO ADDITIONAL INCISIONS OR REMOVAL OF BONE. 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 25485221 ↗InjuryJun 10, 2026Fracture
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN INTERNAL FIXATION HIP SURGERY DURING WHICH S+N NAILS, SCREWS, AND ROD WERE IMPLANTED. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH PAIN IN THE LEFT LEG DUE TO A FALL. X-RAYS CONFIRMED THAT THE NAILS, SCREWS, AND ROD WERE FRACTURED. THE PATIENT SUBSEQUENTLY UNDERWENT REVISION SURGERY TO RESOLVE THE ISSUE. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Fall; Implant Pain; Loss of fracture reduction
MAUDE report 25460226 ↗MalfunctionJun 7, 2026Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) MEDIUM HEXDRIVER BROKE. THE PARTS WERE ALL ACCOUNTED FOR AND DISPOSED OF BY HOSPITAL STAFF. 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 25422607 ↗MalfunctionJun 1, 2026Fracture
IT WAS REPORTED THAT, DURING A FEMORAL NAIL SURGERY, THE TIP OF ONE (1) INTERTAN 7.0MM COMP SCREW STARTER DRILL SNAPPED OFF DURING USE AND COULD NOT BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 25354048 ↗MalfunctionJun 1, 2026Use of Device Problem; Failure to Align
IT WAS REPORTED THAT, DURING A META-TAN SURGERY, THE SURGICAL TEAM REPORTED THAT THE SYSTEM OF ONE (1) META-TAN DROP, ONE (1) META-TAN LAG SCREW DRILL SLEEVE AND ONE (1) META-TAN GUIDE PIN SLEEVE WAS MISALIGN, AS THEY INSERTED A GUIDE WIRE (GUIDE PIN 3.2MM X 343MM) AND WHEN THEY SCREWED THE CANNULATED LAG SCREW OVER THE WIRE, THE WIRE SNAPPED. 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 25354010 ↗MalfunctionJun 1, 2026Fracture; Use of Device Problem
IT WAS REPORTED THAT, DURING A META-TAN SURGERY, THE SURGICAL TEAM REPORTED THAT THE SYSTEM OF ONE (1) META-TAN DROP, ONE (1) META-TAN LAG SCREW DRILL SLEEVE AND ONE (1) META-TAN GUIDE PIN SLEEVE WAS MISALIGN, AS THEY INSERTED A GUIDE WIRE (GUIDE PIN 3.2MM X 343MM) AND WHEN THEY SCREWED THE CANNULATED LAG SCREW OVER THE WIRE, THE WIRE SNAPPED. 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 25347671 ↗MalfunctionMay 31, 2026Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) MEDIUM HEXDRIVER BROKE IN THE THREADED HEAD OF A SCREW WHILE THREADING IT IN THE SCREW HOLE. 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 25343055 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF AN INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. HOWEVER, IT IS UNKNOWN IF THIS CAUSES ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25342849 ↗MalfunctionMay 27, 2026Fracture
IT WAS REPORTED THAT, DURING AN INTERTAN FEMORAL NAIL SURGERY, ONE (1) T-HANDLE HAD A LIP NEAR THE CONNECTION POINT THAT BROKE OFF DURING SCREW INSERTION. NO PIECES WERE INSIDE PATIENT. 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 25310918 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL SURGERY, ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR FRACTURED. NO PIECES FELL IN THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (SWITCHING TO ANOTHER RETAILER). NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25211778 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL SURGERY, THE NAIL WAS INSERTED AND THE SUBTROCHANTERIC SCREW PLACEMENT TECHNIQUE WAS PERFORMED, BUT AT THE TIME OF GIVING THE LAST TURNS OF INSERTION, IT WAS NOTICED THAT THE SCREW HANDLE CAME LOOSE. UPON REMOVING THE HANDLE, IT WAS NOTICED THAT ONE (1) SUBTROC LAG SCREW HEXDRVR ROD WAS FRACTURED. NO PIECES FELL INSIDE THE PATIENT. 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 25211759 ↗
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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page