BIORCIRecalls & reported problems across all models
Smith & Nephew, Inc. · 32 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 552
- Deaths reported
- 0
- Injuries reported
- 177
- Recalls
- 0
We found 32 models of BIORCI by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 552 adverse event reports in the FDA's MAUDE database, received between Jun 20, 2017 and Jun 15, 2026 — classified as 177 injuries, 375 malfunctions.
The most frequently reported specific device problem is “Break” (435 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 BIORCI problems
Device problems
- Break435
- Material Separation77
- Fracture8
- Device Dislodged or Dislocated6
- Material Fragmentation6
- Adverse Event Without Identified Device or Use Problem5
- Crack5
- Detachment of Device or Device Component5
Patient problems
- No Clinical Signs, Symptoms or Conditions288
- No Known Impact Or Consequence To Patient209
- Foreign Body In Patient18
- No Information14
- No Consequences Or Impact To Patient9
- Device Embedded In Tissue or Plaque5
- Injury5
- Insufficient Information4
BIORCI models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIORCI 7207678Screw, fixation, bone74 reports
- BIORCI 7207674Screw, fixation, bone73 reports
- BIORCI 7207682Screw, fixation, bone60 reports
- BIORCI 7207679Screw, fixation, bone44 reports
- BIORCI 7207681Screw, fixation, bone39 reports
- BIORCI 7207677Screw, fixation, bone35 reports
- BIORCI 7209017Screw, fixation, bone28 reports
- BIORCI 7209016Screw, fixation, bone25 reports
- BIORCI 7207554Screw, fixation, bone22 reports
- BIORCI 7207560Screw, fixation, bone20 reports
- BIORCI 7207561Screw, fixation, bone15 reports
- BIORCI 7207675Screw, fixation, bone15 reports
- BIORCI 7209014Screw, fixation, bone13 reports
- BIORCI 7207557Screw, fixation, bone10 reports
- BIORCI 7207564Screw, fixation, bone10 reports
- BIORCI 7207916Screw, fixation, bone9 reports
- BIORCI 7207563Screw, fixation, bone8 reports
- BIORCI 7207686Screw, fixation, bone8 reports
- BIORCI 7207683Screw, fixation, bone7 reports
- BIORCI 7207555Screw, fixation, bone6 reports
- BIORCI 7207676Screw, fixation, bone6 reports
- BIORCI 7207566Screw, fixation, bone4 reports
- BIORCI 7207558Screw, fixation, bone3 reports
- BIORCI 7207568Screw, fixation, bone3 reports
- BIORCI 7207680Screw, fixation, bone3 reports
- BIORCI 7207918Screw, fixation, bone3 reports
- BIORCI 7207567Screw, fixation, bone2 reports
- BIORCI 7209012Screw, fixation, bone2 reports
- BIORCI 7209018Screw, fixation, bone2 reports
- BIORCI 7207607Screw, fixation, bone1 report
- BIORCI 7209023Screw, fixation, bone1 report
- BIORCI 7209020Screw, fixation, bone1 report
Recent BIORCI adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2026Fracture
IT WAS REPORTED THAT DURING AN ACL ARTHROSCOPY PROCEDURE, THE TIP OF ONE (1) SCR BIORCI HA SCREW BROKE DURING TIBIAL GRAFT FIXATION. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY USING A SIMILAR S+N BACK-UP PRODUCT IN THE SAME BONE HOLE. NO VOID WAS LEFT IN THE PATIENT. THE INSERTION SITE WAS PREPARED USING A GUIDE WIRE AND SCREWDRIVER OF BIORCI-HA, AND IT WAS CONFIRMED THAT THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO ANCHOR INSERTION. ALL PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT USING A GRASPER. THE PATIENT IS CURRENTLY IN GOOD CONDITION. 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 25513311 ↗MalfunctionMay 25, 2026Break
IT WAS REPORTED THAT DURING A LET REPAIR PROCEDURE, THE SCREW BIORCI-HA BROKE WHILE INSERTING IN THE TUNNEL. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING SIMILAR S+N BACK UP PRODUCT ON AN ADDITIONAL BONE HOLE USING THE SAME SIZE SCREW. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 25271643 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED DURING A KNEE ARTHROSCOPY, ONE (1) BIORCI SCREW GOT BROKEN WHILE INSERTION AT TIBIAL SITE. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT. 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 25210664 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, ONE (1) BIORCI SCREW BROKE WHILE INSERTION AT SITE. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT. 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 25210632 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ACL RECONSTRUCTION PROCEDURE, THE BIORCI-HA SCREW GOT BROKE WHILE INSERTING INTO THE TIBIAL TUNNEL. THE BROKEN PARTS WERE REMOVED USING ARTERY, FORCEPS & SUCTION. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT ON THE ORIGINALLY DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS SAFE AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062185 ↗MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT, DURING AN ACL, THE TIP OF THE BIORCI HA GOT BROKEN DURING THE INSERTION AT THE TIBIAL SITE. 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 24896265 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED THAT DURING AN ACL SURGERY, ONE (1) BIORCI SCREW BROKE AT THE TIP DURING INSERTION AT SITE. 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 24887793 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, BIORCI-HA SCREW GOT CUT WHILE INSERTING IT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24678015 ↗MalfunctionMar 23, 2026Fracture
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, ONE (1) BIORCI-HA INTERFERENCE SCREW FRACTURED INTRAOPERATIVELY. THE FAILURE OCCURRED WHILE THE SCREW WAS BEING DRIVEN INTO THE BONE TUNNEL. THE SCREW SHEARED UNDER NORMAL INSERTION TORQUE WHEN IT WAS APPROXIMATELY 2/3 (TWO-THIRD) INSERTED. THE POSTERIOR 1/3 (THE PORTION CLOSEST TO THE DRIVER) BROKE OFF AND WAS OUTSIDE THE TUNNEL. HOWEVER, THE ANTERIOR 2/3 OF THE SCREW REMAINED DEEPLY LODGED AND SECURELY FIXED WITHIN THE BONE TUNNEL. THE SURGEON HAD TO UTILIZE A COMBINATION OF ARTHROSCOPIC GRASPERS AND A REVERSE SCREW TECHNIQUE (ENGAGING THE BROKEN FRAGMENT TO BACK-THREAD IT OUT) TO SUCCESSFULLY CLEAR THE TUNNEL. THE SURGEON SUCCESSFULLY RETRIEVED ALL FRAGMENTS OF THE FRACTURED BIO-COMPOSITE SCREW FROM THE BONE TUNNEL. THE TUNNEL WAS THOROUGHLY IRRIGATED AND INSPECTED TO CONFIRM NO DEBRIS OR MATERIAL REMNANTS WERE LEFT BEHIND. THE PROCEDURE WAS RESUMED, WITH A DELAY GREATER THAN 30 MIN, USING A SIMILAR S+N BACK-UP PRODUCT. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24667490 ↗MalfunctionFeb 16, 2026Break
IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIORCI-HA SCREW BROKE WHILE BEING INSERTED INTO THE BONE. 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 24353677 ↗MalfunctionJan 26, 2026Break
IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT AFTER DRILLING THE HOLE AND TRY TO SCREW IN BESIDE THE GRAFT, THE BIORCI SCREW BROKE WHILE INSERTING. SCREW FRAGMENTS WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177654 ↗MalfunctionJan 26, 2026Break
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, AFTER THE INSERTION SITE WAS PREPARED WITH AN 8 MM CANNULATED DRILL, TUNNEL SIZE OF 8 MM, AND ALL DEBRIS WERE CLEARED, A BIORCI-HA SCREW WAS INTRODUCED WITH THE APPROPRIATE SCREWDRIVER BUT GOT BROKEN DURING INSERTION. ALL BROKEN PIECES WERE REMOVED USING ARTERY FORCEPS AND SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH STATUS IS SAFE. THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177516 ↗MalfunctionDec 5, 2025Break; Break
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE BIORCI SCREW GOT BROKEN WHILE PUTTING INTO THE BONE. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED; HOWEVER, THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727657 ↗MalfunctionDec 5, 2025Break; Break
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE BIORCI SCREW TIP GOT BROKEN WHILE PUTTING INTO THE BONE. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED; HOWEVER, THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727613 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE SCREW BIORCI BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING A SIMILAR SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700568 ↗
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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