OSTEORAPTOR 72201993Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 03596010615541), received between Jul 24, 2017 and May 26, 2026 — classified as 35 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Break” (64 reports).

40 other recalls cover devices cleared under the same FDA submission (K151105); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• 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 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 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 ↗
• 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 ↗
• MalfunctionMar 31, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, ONE (1) OSTEORAPTOR ANCHOR WAS MISUSED BY THE DOCTOR AND IT WAS REMOVED WITH 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 24750408 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, AFTER THE INSERTION SITE WAS PREPARED WITH AN ANCHOR MATCHING INSTRUMENT AND CLEARED OF ALL DEBRIS, AN OSTEORAPTOR ANCHOR'S SUTURE BROKE WHEN TYING THE KNOT. THE BROKEN PIECES WERE REMOVED USING FORCEPS. 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 24663083 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT WHEN ANCHORING AND DELIVERING THE FIRST IMPACT OF THE OSTEORAPTOR, IT BROKE IN HALF, MAKING PLACEMENT UNSUCCESSFUL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP DEVICE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958126 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE JOINT LIGAMENT REPAIR SURGERY, THE OSTEORAPTOR ANCHOR BROKE. THE BROKE PIECES WERE REMOVED FROM INSIDE THE PATIENT USING TWEEZERS AND A GRASPER. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP INSERTED INTO THE ORIGINAL BONE HOLE, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700948 ↗
• MalfunctionNov 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROPLASTY PROCEDURE, THE OSTEORAPTOR ANCHOR BROKE DUE TO THE ANGLE OF THE INJURY UPON THE IMPACT. THE BROKEN PIECES WERE REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665468 ↗
• MalfunctionSep 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER JOINT LABRUM REPAIR SURGERY, IT WAS NOTICED THAT THE OSTEORAPTOR ANCHOR BROKE WHILE BEING IMPLANTED .ALL THE PIECES WERE REMOVED WITH GRASPING FORCEPS AND SUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY USING AN EQUIVALENT S+N BACK-UP. THE BACK UP WAS USED IN THE ORIGINALLY DRILLED BONE. THERE WAS NO VOID LEFT IN THE PATIENT AND THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS A 2.3MM ANCHOR MATCHING INSTRUMENT. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23181064 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY FOR LIGAMENT INJURY OF THE LEFT ANKLE JOINT, AN OSTEORAPTOR ANCHOR WAS USED, BUT THE ANCHOR BROKE. THE PIECES WERE RETRIEVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED HOLE; THERE WERE NO VOIDS LEFT IN THE PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102722 ↗
• MalfunctionMay 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A HIP JOINT REPAIR SURGERY, THE OSTEORAPTOR ANCHOR BROKE IN THE MIDDLE. SURGERY WAS COMPLETED WITH A NEW ANCHOR OF THE SAME MODEL PLACED IN THE ORIGINALLY DRILLED BONE HOLE, WHICH WAS PREPARED WITH A 2.3 MM INSTRUMENT AND CLEARED OF ALL DEBRIS, NO VOID WAS LEFT IN PATIENT. THE SEVERED PART WAS REMOVED FROM THE BODY, ALTHOUGH IT WAS VERY DIFFICULT. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S CONDITION IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053278 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER LABRUM REPAIR, THE OSTEORAPTOR 2.3 W. UB COBRAID BLUE ANCHOR BROKE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE AND LEAVING NO VOID IN PATIENT. ALL THE BROKEN PARTS WERE REMOVED USING TWEEZERS. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023917 ↗
• MalfunctionMay 2, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER PELVIS AND LIP REPAIR, THE GUIDE 2.3 INLINE DRILL AND THE OBTURATOR 2.3 NON-CANNULATED WERE FIRST USED TO ENTER THE JOINT ALONG TO LOCATE THE IDEAL ANCHOR IMPLANTATION POINT, AND THEN PULLED OUT THE OBTURATOR 2.3 NON-CANNULATED. THE SURGEON HELD THE GUIDE 2.3 INLINE DRILL TO FIRMLY LOCATE THE POSITION. THE ASSISTANT USED THE SPECIAL DRILL BIT DRILL FLUTED 2.6MM TO REACH THE DEPTH LIMIT POSITION AND IMPLANTED THE OSTEORAPTOR ANCHOR. WHEN ONE-THIRD OF THE ANCHOR WAS IMPLANTED, IT WAS FOUND THAT THE ANCHOR SPLIT. THE ANCHOR WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954317 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED THAT DURING REPAIR SURGERY FOR TORN SHOULDER AND LABRUM, THE OSTEORAPTOR ANCHOR WAS BROKEN. ALL BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE, IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574697 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A REPAIR OF THE ANTERIOR TALOFIBULAR LIGAMENT OF THE RIGHT ANKLE, TWO OSTEORAPTOR ANCHOR DEVICES (B)(4) BROKE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT BY SUCTION. THE SURGERY WAS COMPLETED USING A BACK-UP DEVICE, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319468 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE JOINT LIGAMENT REPAIR SURGERY, THE OSTEORAPTOR ANCHOR BROKE AND COULD NOT BE USED. THE BROKEN PIECES WERE REMOVED FROM THE INSIDE THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY BONE HOLE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251851 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BACK END OF THE OSTEORAPTOR ANCHOR BROKE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797064 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ANCHOR OF THE OSTERAPTOR BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. ALL PIECES WERE REMOVED FROM THE PATIENT USING GRASPERS. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE SO NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402113 ↗
• MalfunctionSep 18, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A HIP JOINT LABRUM REPAIR SURGERY, THE OSTEORAPTOR ANCHOR PULLED OUT AFTER BEING IMPLANTED AND WHEN THE SUTURE KNOT WAS TIGHTENED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE WITH A SURGICAL DELAY LESS THAN 30 MINUTES. NO VOID LEFT TO THE PATIENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245826 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT THE OSTEORAPTOR ANCHOR BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT, AND IF THERE WAS A DELAY. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. NO FURTHER COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071517 ↗
• MalfunctionAug 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE OSTERORAPTOR ANCHOR CAME LOOSE FROM THE CABLE. AFTER THE MALFUNCTION THE ANCHOR DID NOT HAVE GOOD FIXATION AND WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927898 ↗
• MalfunctionMay 27, 2024Crack; Crack

  IT WAS REPORTED THAT, DURING A HIP SURGERY, THE OSTEORAPTOR'S ANCHOR CRACKED WHEN IT WAS HAMMERED. THE THREAD WAS PULLED OUT, AND THE ANCHOR WAS LEFT IN THE PATIENT. FINALLY, THE BROKEN ANCHOR WAS REMOVED WITH SURGICAL TOOL. SURGERY WAS COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400955 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR TALOFIBULAR LIGAMENT OF THE RIGHT ANKLE SURGERY, THE OSTEORAPTOR ANCHOR BROKE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE AND NO VOID WAS LEFT IN THE PATIENT AND ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. NO FURTHER COMPLICATIONS WERE REPORTED. CURRENT STATUS OF PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214363 ↗
• MalfunctionApr 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DURING AN UNSPECIFIED ARTHROSCOPY, THE OSTEORAPTOR ANCHOR WAS DEFORMED AFTER IMPLANTATION. THE DEFORMED ANCHOR WAS REMOVED FROM THE PATIENT USING SURGICAL TOOL. NO VOID WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE IN THE ORIGINALLY BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161207 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151105. One submission often covers many models, so check the product and lot details in each record.

• Z-0155-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
• Z-0143-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
• Z-0147-2021 · Sep 9, 2020 · Open, Classified
  RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
• Z-0150-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
• Z-0138-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
• Z-0151-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
• Z-0162-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
• Z-0141-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
• Z-0153-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
• Z-0165-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
• Z-0156-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
• Z-0146-2021 · Sep 9, 2020 · Open, Classified
  BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
• Z-0158-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
• Z-0145-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
• Z-0168-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704

…and 25 more.