MILAGRO 231800Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886705010684), received between Mar 27, 2018 and Dec 15, 2025 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

5 other recalls cover devices cleared under the same FDA submission (K060830, K150209); 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, WHILE USING THE MILAGRO INTSCR 7X23MM AND THE TRUESPAN 12 DEGREE PEEK DEVICES, AFTER 1ST FIRING, COULD NOT FIRE AGAIN. WHEN INSERT THE SCREW, THE SCREW'S WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICES WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804905 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS OBSERVED THAT THE SCREW OF THE MILAGRO INTSCR 7X23MM DEVICE BROKE OFF UPON INSERTION. ALL THE BROKEN PARTS WERE REMOVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959777 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INTSCR 7X23MM ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252888 ↗
• MalfunctionJan 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT WHEN THE MILAGRO INTSCR 7X23MM DEVICE ANCHOR WAS INSERTED, IT WAS NOTED THAT THE ANCHOR WAS PEELED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218681 ↗
• MalfunctionJan 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANKLE RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT UPON INSERTING THE ANCHOR OF THE MILAGRO INTSCR 7X23MM *EA DEVICE, THE THREAD ON THE ANCHOR BECAME PEELED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081374 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT DURING THE AN UNSPECIFIED SURGICAL PROCEDURE, THE MILAGRO INTSCR 7X23MM DEVICE SCREW WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026906 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE MILAGRO INTSCR 7X23MM DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179743 ↗
• MalfunctionOct 25, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE (B)(6) 2023 THE MILAGRO INTSCR 7X23MM DEVICE, WAS NOTED TO HAVE A STRIPPED THREAD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003723 ↗
• MalfunctionFeb 22, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 7MM X 23MM BIOCRYL RAPIDE INTERFERENCE SCREW DEVICE BROKE. REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420826 ↗
• MalfunctionOct 31, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 7MM X 23MM BIOCRYL RAPIDE INTERFERENCE SCREW DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700824 ↗
• MalfunctionMar 7, 2022Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6). THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE MILAGRO INTSCR 7X23MM DEVICE REMAINED ADHERED TO THE SCREWDRIVER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD MARKS OF USE AND LITTLE SPOTS OF BIOLOGICAL MATTER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685631 ↗
• MalfunctionNov 23, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE MILAGRO INTSCR 7X23MM ANCHOR COULD NOT BE SECURED IN THE BONE HOLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863181 ↗
• MalfunctionDec 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE MILAGRO INTSCR 7X23MM EA ANCHOR DEVICE COULD NOT BE TIGHTENED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS WARPED; AND THE ROUND SURFACE HAD AN OVAL LOOK LIKE WHEN REVIEWING AT THE HEXAGONAL DRIVER HOLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055958 ↗
• InjuryAug 14, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT REPORTED BY AFFILIATE VIA EMAIL A PATIENT WITH MASSIVE RUPTURE OF THE ROTATOR CUFF, THE SURGICAL PLANNING CHOSEN WAS TO PERFORM A TENODESIS OF THE BICEPS TENDON, WE USED OUR EQUIPMENT FOR THIS PROCEDURE. THE KISCHNER PIN OF THE APPROPRIATE LENGTH WAS NOT AVAILABLE TO PERFORM THE STEP OF PASSING THE SCREW AND FIXING THE TENDON, WHEN TRYING TO FIND A PIN OF LESS LENGTH THAN REQUIRED (1.6 X 280) IT WAS INSUFFICIENT TO RETAIN THE PIN IN THE HOLE OF THE HUMERAL HEAD AND REMOVE THE SOCKET OR RETAINER, WITH WHICH IT WAS NOT POSSIBLE TO DO THIS STEP, AFTER TWO UNSUCCESSFUL ATTEMPTS THE TENDON BREAKS CAUSING A RETRACTION OF THE STUMP AND MAKING IT IMPOSSIBLE TO FIX THE TENDON AND AFFECT THE REHABILITATION OF THE PATIENT. IT WAS ALSO REPORTED A 30 MINUTE DELAY OCCURRED.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 10410582 ↗
• MalfunctionMar 5, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE TIP OF THE MILAGRO INTSCR 7 X 23MM, EA BROKE OFF UPON INSERTION. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9795151 ↗
• MalfunctionDec 26, 2019Deformation Due to Compressive Stress; Material Twisted/Bent; Naturally Worn; Deformation Due to Compressive Stress; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A KNEE ARTHROSCOPY, IT WAS OBSERVED THAT THE MILAGRO SCREW SLID THROUGH THE SCREWDRIVER, PREVENTING IT FROM LEAVING THE HANDLE, SO THE IMPLANT COULD NOT BE USED. IT WAS REPORTED THAT THE SURGEON PERFORMED THE SURGICAL TECHNIQUE CORRECTLY AND HE DID NOT PERFORM MUCH FORCE ON THE DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THROUGH VISUAL INSPECTION THAT THE THREADS ON THE EXTERIOR OF THE DEVICE WERE FLATTEN AND DAMAGED. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE NOR IF A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520717 ↗
• MalfunctionNov 22, 2019Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING THE PROCEDURE OF AN ANKLE LIGAMENT RECONSTRUCTION, IT WAS OBSERVED THAT THE 6X12 MILAGRO INTERFRENCE SCREW WAS BROKEN OFF INTO TWO PIECES UPON SCREWING. IT WAS REPORTED THAT THE PIECES WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE SAME THING HAPPENED WHEN SCREWING THE MILAGRO INTSCR 7X23MM *EA WHICH WAS BROKEN OFF INTO TWO PIECES. IT WAS REPORTED THAT ONE OF THE PIECES WAS NOT ABLE TO BE REMOVED BECAUSE IT WAS INSERT INTO THE BONE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9363121 ↗
• MalfunctionAug 2, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING A LCA RECONSTRUCTION AT THE MOMENT OF INTRODUCING THE SCREW TO FIX THE LIGAMENT IT WAS OBSERVED THAT THE SCREW HAD FRACTURED. NO SHARP FORCE WAS EXERTED. IN TRYING TO CONFIRM IF THE GREAT MAJORITY OF THE SCREW HAD BEEN ALREADY INSIDE THE TUNNEL WE THOUGHT THAT THE LIGAMENT HAD ALREADY BEEN FIXED, HOWEVER WE DETECTED THAT THEY WERE PURE RESIDUES OF THE SCREW, PRACTICALLY LIKE A FLOUR, FOR THIS REASON ANOTHER SCREW WAS USED, THE EXPIRATION DATE OF THE SCREW WAS OBSERVED AND THE BOX WAS "OK". THE IMPLANT BEFORE USE WAS COMPLETELY SEALED. WHAT IS LEFT OF THE SCREW IS SAVED FOR ITS RESPECTIVE STUDY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8855674 ↗
• InjuryMay 14, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A BICEPS TENODESIS PROCEDURE THE CUSTOMER'S 7X23MM MILAGRO INTERFERENCE SCREW WAS INSERTED INTO THE PATIENT, BUT WAS SITTING PROUD. THE SCREW WAS FULLY REMOVED WITH NO DEBRIS LEFT BEHIND. THE SALES REP STATED THAT THE SURGEON DRILLED A SIZE EIGHT TUNNEL AND FOLLOWED THE SIZING TECHNIQUE. THE SALES REP STATED THAT THE SUTURES WERE PULLED DURING THE CASE AND THE PATIENT'S BICEP RUPTURED NEAR THE SOCKET. THE CASE WAS NOT COMPLETED AND THERE IS NO PLAN FOR FUTURE SURGICAL INTERVENTION. THE MILAGRO SCREW WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Code Available

  MAUDE report 8608788 ↗
• InjuryDec 26, 2018Migration or Expulsion of Device; Deformation Due to Compressive Stress; Material Twisted/Bent; Migration or Expulsion of Device; Deformation Due to Compressive Stress; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON 01/11/2019 STATING THAT THE ADVERSE EVENT WAS A POSSIBLE PULLOUT OF IMPLANT FROM THE BONE ON (B)(6) 2018. THE CASE WAS COMPLETED BY OPENING ANOTHER STOCK. ADDITIONAL INFORMATION WAS RECEIVED BY THE AFFILIATE ON 01/16/2019 STATING THAT THE EVENT OCCURRED INTA-OP. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THERE WAS NO PATIENT HARM DUE TO THIS DELAY. THE CASE WAS COMPLETED WITH ANOTHER READILY AVAILABLE DEVICE. THE AFFILIATE ALSO STATED THAT THE SURGEON WAS NOT OFF-AXIS WHILE THEY WERE USING THE IMPLANT AND THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable; Tissue Damage

  MAUDE report 8197099 ↗
• MalfunctionDec 18, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A KNEE ARTHROSCOPY PROCEDURE THE CUSTOMER'S 7X23MM MILAGRO INTERFERENCE SCREW BROKE IN HALF WHILE INSERTING INTO THE PATIENT. THE SALES REP STATED THAT THE DISTAL END OF THE SCREW WAS LEFT IN THE PATIENT DUE TO GOOD FIXATION AND THE PROXIMAL END WAS REMOVED. THE SALES REP STATED THE PATIENT HAD NORMAL BONE AND THERE WERE NO PROCEDURAL OR ANATOMY FACTORS THAT CONTRIBUTED TO BREAKAGE. THE CASE WAS COMPLETED WITH THE DISTAL HALF OF THE SCREW WITH NO PATIENT HARM OR DELAY. THE PROXIMAL END OF THE SCREW WILL BE RETURNING FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175547 ↗
• MalfunctionAug 23, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING A BTB ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S MILAGRO INTERFERENCE SCREW 7 X 23MM BROKE MIDBODY WHEN BEING SCREWED INTO THE BONEHOLE. THE SALES REP REPORTED THE SCREW WAS STILL ON THE INSERTER WHEN THE DEVICE BROKE MIDBODY. THE SALES REP REPORTED THE BACK HALF BROKE INTO FRAGMENTS BUT THE TOP HALF WAS SECURELY IMPLANTED AND THE SURGEON COULD NOT REMOVE IT. THE SURGEON COMPLETED THE PROCEDURE WITH A TITANIUM SCREW IMPLANTED OVER THE BROKEN SCREW WITH NO PATIENT CONSEQUENCES AND A FIVE MINUTE DELAY. THE SALES REP REPORTED THAT THE SURGEON WAS HAPPY WITH THE FIXATION. THE SALES REP REPORTED THAT THE SURGEON USED AN ANTEROMEDIAL APPROACH AT A DRASTIC ANGLE WHICH MAY HAVE CONTRIBUTED TO THE DEVICE BREAKING. THE SALES REP REPORTED THAT THE SURGEON DID NOT TAP AND THE BONE QUALITY WAS GOOD. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7808686 ↗
• MalfunctionAug 20, 2018Break; Break

  THE THREAD OF THE SCREW WAS BROKEN DURING THE SURGERY WHEN THE SURGEON INSERTED THE DEVICE WITHOUT TAPPING. TITANIUM SCREW FROM COMPETITOR WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799660 ↗
• MalfunctionAug 1, 2018Crack; Crack

  IT WAS REPORTED BY THE AFFILIATE THAT SCREW BROKE DURING DRILL IN THE FUMORAL BONE IN SPITE OF USING CORACOID STEP TAP AND MODULAR DRIVER 23MM. REST OF THE SCREW IS IN THE BONE. PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7740193 ↗
• MalfunctionJul 27, 2018Break; Break

  SCREW BREAKAGE. THE SCREW BROKE IN UNKNOWN PROCEDURE. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. CHANGED NEW ONE TO COMPLETE. THERE WAS NO ADVERSE EVENT ON PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7727717 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060830, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722