OSTEORAPTOR 72201995Recalls & reported problems

Summary

The FDA's MAUDE database contains 253 adverse event reports that list this exact device (DI 03596010615565), received between Aug 14, 2017 and Jun 21, 2026 — classified as 91 injuries, 162 malfunctions.

The most frequently reported specific device problem is “Break” (154 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 253 reports, 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 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 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 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 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 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC DISLOCATION SURGERY OF THE SHOULDER JOINT, THE OSTEORAPTOR ANCHOR BROKE. ALL TH EPIECES WERE REMOVED WITH FORCEPS AND SUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY USING AN EQUIVALENT SN BACK-UP. THE BACK UP WAS USED IN THE ORIGINAL DRILLED HOLE, NO VOIDS WERE LEFT, THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS A 2.9 MM ANCHOR MATCHING INSTRUMENT. THE PATIENT STATUS WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714583 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, AN OSTEORAPTOR ANCHOR BROKE DURING IMPLANTATION. 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 24707130 ↗
• MalfunctionMar 4, 2026Fracture

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPIC PROCEDURE, THE OSTEORAPTOR'S THREE PIECE SET FUNCTIONED NORMALLY AND ACHIEVED NORMAL OPENING, HOWEVER, THE SCREW COULD NOT ADVANCE INTO POSITION AND FRACTURED DURING IMPACTION. 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 24511950 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT, DURING SURGERY, 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 24479919 ↗
• MalfunctionFeb 8, 2026Fracture

  IT WAS REPORTED THAT DURING A REPAIR OF LATERAL HUMERAL LIGAMENT OF ELBOW JOINT PROCEDURE, IT WAS NOTICED THAT OSTEORAPTOR 2.9 ANCHOR GOT FRACTURED DURING IMPLANTATION. THE PROCEDURE WAS RESUMED, USING AN S+N EQUIVALENT BACK UP PRODUCT, HOWEVER IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288443 ↗
• MalfunctionFeb 7, 2026Break

  IT WAS REPORTED THAT, DURING A BRISTOW BANKART PROCEDURE, WHEN THE OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE WAS INSERTED INTO THE BONE HOLE, IT FRACTURED. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS AND ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A 5-MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24285987 ↗
• MalfunctionFeb 5, 2026Material Deformation

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN INSERTING THE OSTEORAPTOR ANCHOR, IT DEVIATED FROM THE ORIGINAL TRAJECTORY, CAUSING THE BENDING TO BE UNUSABLE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268263 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT DURING AN ANKLE LIGAMENT REPAIR SURGERY, THE OSTEORAPTOR ANCHOR BROKE. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP ON THE ORIGINALLY DRILLED HOLE, PREPARED WITH ANCHOR MATCHING INSTRUMENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259292 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT DURING AN ANKLE LIGAMENT REPAIR SURGERY, THE OSTEORAPTOR ANCHOR BROKE. ALL THE PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247456 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF AND LABRUM REPAIR SURGERY, THREE (3) UNITS OF A OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE WERE FRACTURED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP. IT IS UNKNOWN IF THERE WAS A DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167755 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF AND LABRUM REPAIR SURGERY, AN OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE BROKE. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP. IT IS UNKNOWN IF THERE WAS A DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130479 ↗
• MalfunctionJan 15, 2026Break; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A GLENOID LABRUM REPAIR, AN OSTEORAPTOR ANCHOR BROKE. 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 24080799 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER DISLOCATION PROCEDURE, IT WAS NOTICED THAT THE OSTEORAPTOR 2.9 ANCHOR'S TIP GOT BROKEN WHILE BEING IMPLANTED. THE BROKEN PARTS WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS AFTER RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT SMITH AND NEPHEW BACK UP DEVICE ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054571 ↗
• MalfunctionJan 12, 2026Fracture

  IT WAS REPORTED THAT, DURING A LABRUM REPAIR SURGERY, THE OSTEORAPTOR ANCHOR WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048485 ↗
• MalfunctionJan 12, 2026Break; Fracture

  IT WAS REPORTED THAT, DURING A GLENOID LABRUM REPAIR, AN OSTEORAPTOR ANCHOR BROKE. 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 24039182 ↗
• MalfunctionDec 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY FOR SHOULDER INSTABILITY, WHILE THE DOCTOR WAS MANEUVERING, THE OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE TIP CAME LOOSE INSIDE. IT WAS REMOVED FROM THE PATIENT WITH 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 23897852 ↗

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-0163-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
• Z-0172-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
• Z-0151-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
• Z-0174-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
• Z-0136-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
• 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-0148-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
• Z-0166-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
• Z-0140-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
• Z-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
• Z-0169-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
• Z-0171-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
• Z-0161-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
• Z-0167-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697

…and 25 more.