ACCU-PASSRecalls & reported problems across all models
Smith & Nephew, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 149
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 0
We found 7 models of ACCU-PASS by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 149 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2018 and May 5, 2026 — classified as 38 injuries, 111 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (38 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 ACCU-PASS problems
Device problems
- Mechanical Jam38
- Break30
- Insufficient Device Problem Information17
- Mechanical Problem13
- Material Separation8
- Difficult to Insert7
- Firing Problem7
- Failure to Eject6
Patient problems
- No Clinical Signs, Symptoms or Conditions88
- No Known Impact Or Consequence To Patient46
- No Information9
- Foreign Body In Patient3
- Rupture2
- Injury1
- Needle Stick/Puncture1
- No Code Available1
ACCU-PASS models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACCU-PASS 72200419ORTHOPEDIC MANUAL SURGICAL INSTRUMENT55 reports
- ACCU-PASS 7210424ORTHOPEDIC MANUAL SURGICAL INSTRUMENT31 reports
- ACCU-PASS 7210423ORTHOPEDIC MANUAL SURGICAL INSTRUMENT26 reports
- ACCU-PASS 23-2005Accessories, arthroscopic19 reports
- ACCU-PASS 7210425ORTHOPEDIC MANUAL SURGICAL INSTRUMENT10 reports
- ACCU-PASS 7210426ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- ACCU-PASS 7210427ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent ACCU-PASS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2026Fracture
IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, THE CURVED TIP OF THE ACCUPASS SNAPPED OFF WHILE THE SURGEON WAS PASSING THE CRESCENT TIP THROUGH THE TISSUE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25082187 ↗MalfunctionApr 28, 2026Break; Material Deformation
IT WAS REPORTED THAT THE ACCUPASS SUTURE PASSER WAS BENT AND BROKEN. 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 25024179 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THAT, DURING A SHOULDER INSTABILITY PROCEDURE, WHEN THE SURGEON WAS TAKING A BITE OF THE LABRUM, AN ACCU-PASS GOT BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700898 ↗MalfunctionNov 25, 2025Break; Break
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, AN ACCU-PASS PROBE BROKE, AS THE METAL PART DETACHED FROM THE PLASTIC. THE BROKEN PART WAS REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS PERFORMED USING A SIMILAR S+N BACK UP PRODUCT, WITH AN UNSPECIFIED SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23647924 ↗MalfunctionAug 26, 2025Break; Break
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE SURGEON WAS USING THE ACCU-PASS DIRECT CRESCENT XL TO PASS THE SUTURE THROUGH THE LABRUM, THE DEVICE BROKE. NO PART OF THE DEVICE BROKE OFF THE MAIN BODY OF THE DEVICE, IT WAS REMOVED BY PULLING THE DEVICE OUT OF THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. 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 22898845 ↗MalfunctionAug 26, 2025Break; Break
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE SURGEON WAS USING THE ACCU-PASS DIRECT CRESCENT XL TO PASS THE SUTURE THROUGH THE LABRUM, THE DEVICE BROKE. NO PART OF THE DEVICE BROKE OFF THE MAIN BODY OF THE DEVICE, IT WAS REMOVED BY PULLING THE DEVICE OUT OF THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. 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 22896570 ↗MalfunctionSep 16, 2024Break; Break
IT WAS REPORTED THAT, DURING SURGERY, THE CURVED PART OF A ACCU-PASS DIRECT SNAPPED OFF WHEN INSERTED INTO THE JOINT. THE BROKEN PART WAS REMOVED FROM THE PATIENT WITH AN ARTHROSCOPIC GRASPER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. 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 20224763 ↗MalfunctionMay 15, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT AN ACCU-PASS HAD PIN HOLES FROM THE INSIDE ALONG THE FLAT SIDE OF THE PACKAGING. AS THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19324133 ↗MalfunctionJan 30, 2024Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWO GUIDES OF THE ACCU-PASS HAD A PROBLEM. SPECIFICALLY, WHEN PASSING THE SUTURE AND TURNING THE WHEELS, THE GUIDE CAME OFF. WHEN THE USER REVIEWED THE GUIDES, THEY SHOWED DETERIORATION AND BREAKAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607740 ↗MalfunctionAug 29, 2023Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER PASSING THROUGH THE CANNULA THE ACCU-PASS TIP, IT WAS IDENTIFIED THAT THE ANGLE CHANGED, THE TIP DID NOT COME LOOSE INSIDE THE PATIENT. IT WAS REMOVED FROM INSIDE THE JOINT AND WHEN LOOKED OUTSIDE IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17646512 ↗MalfunctionJul 17, 2023Break; Break
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ACCUPASS BROKE WHEN TRYING TO SUTURE THE MENISCUS, THE AREA WAS OF DIFFICULT ACCESS. SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17339332 ↗MalfunctionApr 17, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING SET UP FOR AN ARTHROSCOPIC SHOULDER INSTABILITY PROCEDURE, WHEN OPENING AN ACCU-PASS DEVICE A STING WAS FELT, LOOKING AT THE SLEEVE IT WAS PIERCED BY THE DEVICE NOZZLE. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16753462 ↗MalfunctionApr 4, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE THE ANCHORS OF TWO (2) ACCU PASS BROKE OFF, AND THE HANDLES DETACHED FROM THE STEMS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A COMPETITORS DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16675979 ↗InjuryMar 24, 2023Break; Break
IT WAS REPORTED THAT DURING A SLAB-REPAIR, WHEN THE PHYSICIAN PASSED THE SUTURE, THE ACCU-PASS BENT AND BROKE. THE BROKEN PART WAS SUCCESSFULLY RETRIEVED BY THE PHYSICIAN USING A GRASPER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16612476 ↗InjuryMar 3, 2023Break; Break
IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE SPECIALIST REQUESTED AN ACCU-PASS WITH A MINITAPE POINT, THE DEVICE WAS LOCATED INSIDE THE JOINT, BUT DECIDED TO RELOCATE IT, AND WHEN TRYING TO PASS THE POINT AGAIN, THE ACCU-PASS BENT. THE SPECIALIST TRIED TO RETRIEVE THE NEEDLE, BUT IT DID NOT GO BACK, AND THE DEVICE BROKE AT THE JUNCTION. THE BROKEN PIECES WERE TAKEN OUT WITH CAUTION TOGETHER WITH THE CANNULA. THE PROCEDURE WAS COMPLETED WITH A 10-MIN DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT'S HEALTH WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16478987 ↗
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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