OSTEORAPTORRecalls & reported problems across all models
Smith & Nephew, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 398
- Deaths reported
- 0
- Injuries reported
- 151
- Recalls
- 0
We found 8 models of OSTEORAPTOR by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 398 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2017 and Jun 21, 2026 — classified as 151 injuries, 247 malfunctions.
The most frequently reported specific device problem is “Break” (249 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 OSTEORAPTOR problems
Device problems
- Break249
- Device Dislodged or Dislocated68
- Fracture36
- Material Separation18
- Crack17
- Material Deformation11
- Detachment of Device or Device Component5
- Material Split, Cut or Torn5
Patient problems
- No Clinical Signs, Symptoms or Conditions287
- No Known Impact Or Consequence To Patient44
- Perforation30
- Foreign Body In Patient14
- Rupture13
- No Information11
- Device Embedded In Tissue or Plaque6
- No Consequences Or Impact To Patient5
OSTEORAPTOR models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OSTEORAPTOR 72201995Screw, fixation, bone253 reports
- OSTEORAPTOR 72201993FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE96 reports
- OSTEORAPTOR 72203290STAPLE, FIXATION, BONE17 reports
- OSTEORAPTOR 72201994FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE14 reports
- OSTEORAPTOR 72201992Screw, fixation, bone9 reports
- OSTEORAPTOR 72201824BIT, DRILL5 reports
- OSTEORAPTOR 72202890BIT, DRILL3 reports
- OSTEORAPTOR 72201996STAPLE, FIXATION, BONE1 report
Recent OSTEORAPTOR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2026Break
IT WAS REPORTED THAT, DURING A SURGERY, THE OSTEORAPTOR ANCHOR BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT 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 25572653 ↗MalfunctionJun 7, 2026Break
IT WAS REPORTED THAT, DURING A SHOULDER GLENOID LABRUM REPAIR PROCEDURE, THE OSTEORAPTOR'S SUTURE BROKE AS THE ANCHOR WAS HAMMERED IN. THE ANCHOR WAS REMOVED USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. AN ADDITIONAL HOLE WAS REQUIRED FOR THE BACK UP DEVICE, THERE WAS A VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 25422739 ↗MalfunctionMay 26, 2026Fracture
IT WAS REPORTED THAT, DURING A SURGERY FOR ANKLE LIGAMENT RUPTURE, THE OSTEORAPTOR WAS FRACTURED. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED HOLE, NO VOIDS WERE LEFT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS AN ANCHOR MATCHING INSTRUMENT AND ALL SITE WAS CLEARED OF DEBRIS. THE PATIENT STATUS WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25280870 ↗MalfunctionMay 26, 2026Fracture
IT WAS REPORTED THAT, DURING A RUPTURE OF THE ANTERIOR TALOFIBULAR LIGAMENT, THE OSTEORAPTOR WAS FRACTURED. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED HOLE, NO VOIDS WERE LEFT IN THE PATIENT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS AN ANCHOR MATCHING INSTRUMENT AND THE SITE WAS CLEARED OF ALL DEBRIS. THE PATIENT STATUS WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25280816 ↗MalfunctionMay 26, 2026Break
IT WAS REPORTED THAT, DURING A HIP LABRAL REPAIR, THE OSTEORAPTOR ANCHOR GOT FRACTURED WHILE INSERTING INTO THE BONE. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279605 ↗MalfunctionMay 21, 2026Fracture
IT WAS REPORTED THAT, DURING AN ANKLE LIGAMENT REPAIR SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS WITH A 2.9MM ANCHOR MATCHING INSTRUMENT, THE SIDE OF ONE (1) OSTEORAPTOR SUTURE ANCHOR WAS FRACTURED INSIDE THE PATIENT. THE ANCHOR AND ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH STRAIGHT FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. 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 25237968 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT, DURING A GLENOID REPAIR, AFTER THE INSERTION SITE WAS PREPARED WITH AN ANCHOR MATCHING INSTRUMENT AND CLEARED OF ALL DEBRIS, AN OSTEORAPTOR ANCHOR WAS FRACTURED. THE BROKEN PIECES WERE REMOVED BY SUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINAL BONE HOLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210475 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT DURING SURGERY, ONE (1) OSTEORAPTOR ANCHOR WAS FRACTURED. THE PROCEDURE WAS PERFORMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25209817 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT, DURING A SURGERY, AN OSTEORAPTOR ANCHOR WAS FRACTURED. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 25209778 ↗MalfunctionMay 5, 2026Break; Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE SUTURE OF ONE (1) OSTEORAPTOR SUTURE ANCHOR BROKE. THE BROKEN ANCHOR WAS COMPLETELY REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. 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 25083156 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT DURING A BANKART REPAIR PROCEDURE, 2.5MM FLUTED DRILL BROKE. A SMALL AMOUNT OF BONE WAS SHAVED FROM THE GLENOID FOSSA TO EXTRACT THE METAL FRAGMENT. THE DRILL FRAGMENT WAS REMOVED FROM INSIDE THE PATIENT USING SUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A 1.5MM JUGGERKNOT COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062280 ↗MalfunctionMay 1, 2026Break; Device Dislodged or Dislocated
IT WAS REPORTED THAT, DURING A SHOULDER JOINT LABRUM REPAIR SURGERY, AFTER THE NAIL IMPLANTATION, IT CAME OFF WHEN THE SUTURE WAS PULLED, AND IT WAS FOUND THE OSTEORAPTOR ANCHOR BROKE. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH GRASPER. THE PROCEDURE WAS COMPLETED, 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 25062226 ↗MalfunctionApr 14, 2026Break
IT WAS REPORTED THAT, DURING A HIP LABRUM REPAIR, ONE (1) OSTEORAPTOR SUTURE ANCHOR BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876279 ↗MalfunctionApr 9, 2026Break; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A SHOULDER JOINT GLENOID LABRUM REPAIR SURGERY, THE OSTEORAPTOR ANCHOR FELL OFF AS THE IMPLANT ENTERED THE BONE TUNNEL, THE ANCHOR APPEARED TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH A S+N EQUIVALENT DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832533 ↗MalfunctionApr 8, 2026Fracture
IT WAS REPORTED THAT, DURING A GLENOID REPAIR, AFTER THE INSERTION SITE WAS PREPARED USING AN ANCHOR MATCHING INSTRUMENT AND CLEARED OF ALL DEBRIS, AN OSTEORAPTOR ANCHOR FRACTURED, RESULTING IN IMPLANT FAILURE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINALLY DRILLED BONE HOLE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824395 ↗
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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