MILAGRO 231822Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886705022274), received between Jul 9, 2018 and Jun 30, 2026 — classified as 8 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (19 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, WHEN THE MILAGRO SCREW WAS INSERTED, IT WAS BROKEN. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A FIVE MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665107 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY WITH A MILAGRO ADVANCE SCREW 9X30MM, THE SCREW SPLIT IN HALF WHILE BEING INSERTED. NO PATIENT HARM OR DELAY WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965784 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT MILAGRO ADVANCE SCREW 9X30MM 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 22663311 ↗
• MalfunctionJul 18, 2025Break; Break

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 9X30MM ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545953 ↗
• MalfunctionMar 3, 2025Break; Break

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING THE LIGAMENT RECONSTRUCTION SURGERY, THE MILAGRO ADVANCE SCREW 9X30MM DEVICE WAS BROKEN OFF, CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN, 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 21502705 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGICAL PROCEDURE WHILE USING THE CORDCUTTER DEVICE WHILE THE SURGEON TRIED TO INSERT THE SCREW THROUGH THE GUIDEWIRE INTO THE TUNNEL, THE SCREW TIP CRACKED. FRAGMENTS WERE GENERATED AND REMOVED SUCCESSFULLY. DURING FURTHER FOLLOW UP WITH THE REPORTER IT WAS STATED THAT "IT WAS BROKEN INTO TWO OR MORE PIECES BUT UNABLE TO RETRIEVE AS THEY MIGHT BE REMOVED BY SUCTION DURING CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421288 ↗
• MalfunctionJan 6, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE MILAGRO ADVANCE SCREW 9X30MM DEVICE ANCHOR THE SCREW BROKE AND GOT LOCKED IN THE KEY, AS IN PHOTO ATTACHED. ANOTHER SCREW OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO DELAY TO THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081152 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE PATIENT THAT DURING AN ANTERIOR/MEDIAL CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE ON APRIL 2023, A RGDLOOP ADJUSTABLE STND DEVICE, MILAGRO ADVANCE SCREW 8X30MM DEVICE AND MILAGRO ADVANCE SCREW 9X30MM DEVICE WERE IMPLANTED ON HER KNEE. ACCORDING TO THE PATIENT, SHE'S BEEN HAVING SENSITIVITY IN THE AREA OF THE IMPLANT (SCREW) TOP OF THE TIBIA BELOW THE KNEE, WHERE THE ACL CONNECTION WAS. PATIENT REPORTED THAT OVER TIME, SHE HAS A PALPABLE LUMP IN THE AREA OF THE IMPLANT WHICH SHE COULD NOT KNEEL WITHOUT DISCOMFORT; AND SYMPTOMS NEVER SUBSIDED POST-OP. PATIENT REPORTED THAT SHE HAS BEEN SCHEDULED FOR THE REMOVAL OF THE IMPLANTS IN A MONTH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Foreign Body Reaction

  MAUDE report 18182252 ↗
• MalfunctionSep 27, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 9X30MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE WAS BROKEN OFF, THEN 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 17825540 ↗
• MalfunctionAug 10, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN MALAYSIA THAT DURING A KNEE SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 9X30MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE BROKE INTO PIECES WHEN THE SURGEON WAS ABOUT TO INSERT IT INTO THE TIBIAL TUNNEL. 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 17500609 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 4 OF 10 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (DPS_JMP_2018_067) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 9X30MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17309045 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (B)(4) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 9X30MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14991160 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 9X30MM DEVICE WAS USED FOR TIBIA FIXATION. POSTOPERATIVELY ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN IN THE ENTIRE KNEE. ON (B)(6) 2021, MRI SHOWED INFLAMMATION AROUND THE IMPLANTS OF THE FEMUR AND TIBIA AND INTRAMEDULLARY EDEMA. ON JULY, THE PATIENT'S KNEE PAIN SUBSIDED, AND A REPEAT MRI SHOWED NO PROBLEMS AS OBSERVED IN MAY. CURRENTLY, THERE IS NO PAIN IN THE KNEE, AND REHABILITATION IS PROGRESSING SMOOTHLY. THE SURGEON COMMENTED THAT IT WAS THE FIRST TIME TO SEE AN INFLAMMATORY REACTION AROUND THE IMPLANT IN THE FEMORAL. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; Pain

  MAUDE report 12754454 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 9X30MM DEVICE WAS USED FOR TIBIA FIXATION. POSTOPERATIVELY ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN IN THE ENTIRE KNEE. ON (B)(6), MRI SHOWED INFLAMMATION AROUND THE IMPLANTS OF THE FEMUR AND TIBIA AND INTRAMEDULLARY EDEMA. ON JULY, THE PATIENT'S KNEE PAIN SUBSIDED, AND A REPEAT MRI SHOWED NO PROBLEMS AS OBSERVED IN MAY. CURRENTLY, THERE IS NO PAIN IN THE KNEE, AND REHABILITATION IS PROGRESSING SMOOTHLY. THE SURGEON COMMENTED THAT IT WAS THE FIRST TIME TO SEE AN INFLAMMATORY REACTION AROUND THE IMPLANT IN THE FEMORAL. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; Pain

  MAUDE report 12422342 ↗
• InjuryJul 21, 2021Break; Break

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL RESEARCH REPORT FROM (B)(6) FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF A MILAGRO ADVANCE SCREW 9X30MM IMPLANT DEVICE WHERE A PATIENT REQUIRED RE-OPERATION APPROXIMATELY SIX MONTHS AFTER ORIGINAL FOR REMOVAL OF BROKEN SCREW. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12203372 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER IN CHINA THAT POSTOPERATIVELY TO AN ARTHROSCOPIC DEBRIDEMENT OF THE RIGHT KNEE WITH MENISCUS TRIMMING AND ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH PLATELET-RICH PLASMA INJECTION PROCEDURE PERFORMED ON (B)(6) 2020 TO TREAT A FRACTURE OF THE RIGHT INTERCONDYLAR EMINENCE OF THE TIBIA CAUSED BY THE TRAFFIC ACCIDENT., IT WAS OBSERVED THAT THE PATIENT SUFFERED INFLAMMATION AND PAIN RED WITH HIGH TEMPERATURE ON THE SKIN AROUND THE WOUND ON (B)(6) 2021. IT WAS REPORTED THAT THE INITIAL DIAGNOSIS WAS: RIGHT TIBIAL BONE CYST. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2021 DUE TO RIGHT KNEE PAIN AND UNFAVORABLE ACTIVITY. IT WAS REPORTED THAT ON (B)(6)2021, ARTHROSCOPIC DEBRIDEMENT AND BONE GRAFTING WERE PERFORMED IN THE RIGHT KNEE UNDER SPINAL ANESTHESIA. IT WAS REPORTED THAT THE PATHOLOGY WAS TAKEN DURING THE OPERATION, AND ANTI-INFECTION TREATMENT WITH CEFUROXIME INJECTION WAS GIVEN POSTOPERATIVELY. IT WAS REPORTED THAT NOW THE WOUND HEALED WELL WITH NORMAL SKIN TEMPERATURE. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11967741 ↗
• MalfunctionMay 25, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 9X30MM DEVICE BROKE WHEN IT WAS SCREWED IN AFTER THE FIRST TURN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11879263 ↗
• MalfunctionMay 12, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT THE MILAGRO ADVANCE SCREW 9 X 30 MM BROKE DURING SURGERY. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10049506 ↗
• MalfunctionJan 22, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA EMAIL, THAT DURING AN ACL PROCEDURE, WHEN THE SURGEON WAS GOING TO INSERT A 9X30MM MILAGRO ADVANCE INTERFERENCE SCREW IN THE TIBIA, THE IMPLANT SUFFERED A RUPTURE BY THE TIP. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. NO SAMPLE WAS KEPT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617535 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT A REPORT RECEIVED FOR IIS (INVESTIGATOR INITIATED STUDIES) WHICH IS AN ACL REGISTRY IN (B)(6) WAS UPLOADED. THE REGISTRY GOAL IS TO CAPTURE ALL ACL PROCEDURES PERFORMED IN (B)(6) AND CURRENTLY HAVE 117 PARTICIPATING SURGEONS. ALL DATA PROVIDED FROM PARTICIPATING SURGEONS IS DE-IDENTIFIED AND CAPTURES ALL PROCEDURES/DEVICES ACROSS ALL INDUSTRY MANUFACTURERS. ON OPENING THE REPORT TO REVIEW THE INFORMATION, AFFILIATE IDENTIFIED THE IMPLANT COMPLICATION RATES FOR ALL DEPUY PRODUCTS CURRENTLY CAPTURED IN THE REGISTRY ON THE LAST PAGE OF THE REPORT. ON DISCUSSION WITH MEDICAL DIRECTOR, THE INFORMATION IS BEING PROVIDED BY THE AFFILIATE TO THE PRODUCT SAFETY FOR ENTRY INTO THE COMPLAINTS SYSTEM AS ¿INFORMATION ONLY¿ GIVEN THE DATA IS CUMULATIVE OVER THE DURATION OF THE REGISTRY; NO FURTHER INFORMATION IS AVAILABLE. THERE IS THE POTENTIAL OF DUPLICATIVE REPORTING IF ANY OF THESE CASES HAVE ALREADY BEEN INDIVIDUALLY (REPORTED TO THE COMPANY) AT THE POINT OF OCCURRENCE (FROM EITHER SURGEON/EMPLOYEE CLINICAL SPECIALIST) AS STATED BY THE AFFILIATE. THE REPORT STATES THAT 1 MILAGRO ADVANCE SCREW 9X30MM; PRODUCT CODE 231822, FAILED DUE TO UNKNOWN

  Patient problems: No Code Available

  MAUDE report 8376291 ↗
• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE 9X30 MILAGRO TAPERED SCREW DEVICE BROKE WHEN BEING INSERTED INTO THE PATIENT DURING AN ANTERIOR CRUCIATE LIGAMENT ACL SURGICAL PROCEDURE. THE CASE WAS COMPLETED USING ANOTHER SCREW IN THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES BUT A 5 MINUTE DELAY WAS REPORTED. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER AND NOT AVAILABLE FOR RETURN. 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 8270924 ↗
• MalfunctionJan 4, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT A NITINOL GUIDEWIRE (FROM ARTHREX) BROKE DURING INSERTION OF A MILAGRO ADVANCE SCREW FOR TIBIA FIXATION. THE NITINOL PIECE WAS FOUND IN THE GRAFT SO THAT THE SURGEON COULD TAKE IT AWAY. THERE WAS A DELAY OF 30 MINUTES BUT NO CONSEQUENCES TO THE PATIENT. THE SURGEON USED A 9X30 MILAGRO ADVANCE WITH SEMIT IN A TUNNEL OF 9. A RE-ACL WITH FILLED BONE (ALLOGRAFT) WAS INVOLVED IN THE PROCEDURE. THE SURGEON CONCLUDED THAT IT TOO MUCH TO PUT A MILAGRO OF 10, SO A 9ER WAS TAKEN. BUT AFTER THE ISSUE THE SURGEON CONCLUDED THAT AN UNDERSIZING WOULD HAVE BEEN BETTER. THE NITINOL GUIDEWIRE PIECE WAS FOUND WITH A CT AND REMOVED. ALSO THE SCREW WAS REMOVED AND A NEW ONE WAS INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED BUT WERE REMOVED EASILY USING X-RAYS TO FIND THE NITINOL GUIDEWIRE PIECE. NO OTHER ADDITIONAL INTERVENTION WAS REQUIRED. IT IS UNKNOWN IF THE PATIENT WAS A PART OF A CLINICAL STUDY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION

  Patient problems: Not Applicable

  MAUDE report 8217164 ↗
• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT DURING ACL PROCEDURE TWO MILAGRO INTERFERENCE SCREWS BROKE INTRAOPERATIVELY WHILE SCREWING IN AND THERE WAS NO PATIENT HARM INDICATED. ADDITIONAL INFORMATION FROM AFFILIATE 8/29/2018: THE UPPER PART OF THE IMPLANT BROKE. THE PATIENT¿S BONE QUALITY WAS STANDARD. NO INFORMATION ON HOW THE CASE WAS COMPLETED. NO SURGICAL DELAY. THE SURGEON/DOCTOR WAS NOT OFF AXIS. THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. IMPLANT WAS REMOVED AND NO DEBRIS WAS LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7869640 ↗
• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT DURING ACL PROCEDURE TWO MILAGRO INTERFERENCE SCREWS BROKE INTRAOPERATIVELY WHILE SCREWING IN AND THERE WAS NO PATIENT HARM INDICATED. ADDITIONAL INFORMATION FROM AFFILIATE 8/29/2018: THE UPPER PART OF THE IMPLANT BROKE. THE PATIENT¿S BONE QUALITY WAS STANDARD. NO INFORMATION ON HOW THE CASE WAS COMPLETED. NO SURGICAL DELAY. THE SURGEON/DOCTOR WAS NOT OFF AXIS. THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. IMPLANT WAS REMOVED AND NO DEBRIS WAS LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7869635 ↗
• MalfunctionAug 1, 2018Break; Break

  TWO MILAGRO INTERFERENCE SCREWS BROKE INTRAOPERATIVELY WHILE SCREWING IN. NO PATIENT CONSEQUENCE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7739601 ↗