ARTHRO-PIERCERecalls & reported problems across all models
Smith & Nephew, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 89
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 0
We found 9 models of ARTHRO-PIERCE by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 89 adverse event reports in the FDA's MAUDE database, received between Sep 1, 2017 and Mar 30, 2026 — classified as 22 injuries, 67 malfunctions.
The most frequently reported specific device problem is “Break” (74 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 ARTHRO-PIERCE problems
Device problems
- Break74
- Fracture5
- Detachment of Device or Device Component3
- Material Deformation3
- Material Separation3
- Material Twisted/Bent3
- Difficult to Open or Close2
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions67
- No Known Impact Or Consequence To Patient15
- Foreign Body In Patient6
- No Information2
- Laceration(s)1
- No Consequences Or Impact To Patient1
ARTHRO-PIERCE models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ARTHRO-PIERCE 7209498ACCESSORIES,ARTHROSCOPIC26 reports
- ARTHRO-PIERCE 7209497ACCESSORIES,ARTHROSCOPIC18 reports
- ARTHRO-PIERCE 7209499ACCESSORIES,ARTHROSCOPIC16 reports
- ARTHRO-PIERCE 7209496ACCESSORIES,ARTHROSCOPIC9 reports
- ARTHRO-PIERCE 72201186ACCESSORIES,ARTHROSCOPIC7 reports
- ARTHRO-PIERCE 72202683ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- ARTHRO-PIERCE 72201187ACCESSORIES,ARTHROSCOPIC3 reports
- ARTHRO-PIERCE 7209499DACCESSORIES,ARTHROSCOPIC2 reports
- ARTHRO-PIERCE 7210226ACCESSORIES,ARTHROSCOPIC1 report
Recent ARTHRO-PIERCE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, IT WAS EVIDENT THAT THE JAW OF THE ARTHROPIERCE WAS FRACTURED.THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715432 ↗MalfunctionMar 7, 2026Break; Degraded; Material Twisted/Bent
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE ARTHROPIERCE BROKE. THE PROCEDURE WAS RESUMED USING A SIMILAR S+N BACKUP. IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24539926 ↗MalfunctionMar 2, 2026Break
IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, WHEN THE DOCTOR TRIED TO PASS AN ARTHROPIERCE STRAIGHT THROUGH THE TENDON, IT BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED. 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 24479950 ↗InjuryFeb 14, 2026Break
IT WAS REPORTED THAT, DURING A LEFT SHOULDER ARTHROSCOPY WITH ROTATOR CUFF REPAIR PROCEDURE, THE ARTHROPIERCE BROKE AND THE TIP GOT LOST IN THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 24341291 ↗MalfunctionFeb 11, 2026Break
IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE FORCEPS OF ONE (1) ARTHROPIERCE 45 DEGREE LEFT BROKE WHILE INSIDE THE PATIENT. THE PIECES WERE REMOVED FROM THE PATIENT ALTHOUGH THE METHOD OF REMOVAL REMAINS UNKNOWN. IT IS ALSO UNKNOWN HOW THE PROCEDURE WAS RESUMED; HOWEVER, THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314611 ↗MalfunctionJan 27, 2026Fracture
IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, WHEN AN ARTHROPIERCE WAS REMOVED, IT WAS EVIDENT THAT IT HAD A VERY STRANGE CURVE. THE SAME WAS OBSERVED WHEN IT WAS INSERTED INTO THE JOINT, AND WHEN THE CAMERA ZOOMED IN, IT BECAME CLEAR THAT IT WAS FRACTURED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192384 ↗MalfunctionJan 7, 2026Break; Material Deformation
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE METAL PIECE OF ONE (1) ARTHROPIERCE INSTRUMENT BROKE WHEN IT PIERCED THROUGH THE ROTATOR CUFF. THE PIECE WAS REMOVED USING A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. THE PATIENT STATUS IS FINE. 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 23989258 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, AFTER PLACING THE ANCHOR, THE DOCTOR USED A LARGE ARTHROPIERCE TO PASS THE WIRE THROUGH THE LABRUM, IT BECAME ENTANGLED IN THE TISSUE AND BROKE, RELEASING THE PIECE INTO THE PATIENT'S JOINT. A FEW MINUTES LATER, THE DOCTOR MANAGED TO FIND AND REMOVE THE ENTIRE BROKEN PIECE USING GRASPER FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A 5-MINUTE DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23915594 ↗MalfunctionDec 22, 2025Break; Break
IT WAS REPORTED THAT, DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT THE ARTHROPIERCE 45 DEGREE LEFT TO THE LEFT, IT BROKE INSIDE THE PATIENT. THE TIP WAS REMOVED WITH THE AID OF A 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 23872770 ↗MalfunctionNov 14, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE LEFT TIP OF THE ARTHROPIERCE WAS BENT AND THE JAW BROKE. 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 23556435 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE ARTHROPIERCE 45 DEGREE LEFT CLAMP BROKE; NO PIECES FELL INSIDE THE PATIENT AND THE PROCEDURE WAS PERFORMED WITHOUT ANY SURGICAL DELAY USING AN EQUIVALENT S+N BACKUP, WITH NO FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279186 ↗MalfunctionAug 26, 2025Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ARTHROPIERCE CLAMP BROKE WHEN IT WAS REMOVED FROM THE JOINT. THE BROKEN PART WAS SEARCHED INTERNALLY AND EXTERNALLY ON THE PATIENT BUT WAS NOT FOUND. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22901395 ↗MalfunctionJul 26, 2025Break; Break
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE UPPER JAW OF THE ARTHROPIERCE 45 DEGREE LEFT FORCEP BROKE DURING INTERACTION WITH THE WIRES. THE BROKEN PIECE FELL INTO THE PATIENT AND WAS COMPLETELY REMOVED WITH A GRASPER FORCEPS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO HARM OR FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22622488 ↗MalfunctionJul 21, 2025Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE ARTHROPIERCE GOT BROKEN, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22562201 ↗MalfunctionJul 20, 2025Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TIP OF THE ARTHROPIERCE GOT BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22552268 ↗
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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