MILAGRO 231821Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886705022267), received between Jul 13, 2018 and Sep 14, 2026 — classified as 5 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763053 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE PROCEDURE THE MILAGRO ADVANCE SCREW 8X30MM ANCHOR DEVICE BROKE. ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086413 ↗
• MalfunctionMay 5, 2026Break

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT OF THE KNEE JOINT PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE RGDFX CRVE ST ACL PLA XPIN SYS DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. IT WAS FURTHER REPORTED THAT THE SCREW ON THE MILAGRO ADVANCE SCREW 7X30MM DEVICE ALSO BROKE OFF. ALL THE PIECES WERE REMOVED FROM THE PATIENT. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. THERE WERE NO DELAYS IN 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 25085089 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF AN UNSPECIFIED JOINT IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X30MM DEVICE WAS BROKEN. THE SURGEON THEN CHANGED TO A 5.5 HEALIX ADVANCE KNTLSS BR ANCHOR DEVICE TO CONTINUE THE PROCEDURE, HOWEVER, THE ANCHOR WAS BROKEN OFF. THE SURGEON CHANGED TO AN OMNISPAN MENISCAL REPAIR 27DEG DEVICE TO CONTINUE THE PROCEDURE, BUT AFTER THE 1ST FIRING, IT WAS OBSERVED THAT TWO PLATES WERE DEPLOYED AT THE SAME TIME. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE [PATIENT. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283932 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, THAT WHEN INSERTING THE MILAGRO ADVANCE SCREW 8X30MM, THE SCREW BROKEN. ALL THE PIECES 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 24274037 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260600 ↗
• MalfunctionFeb 3, 2026Break

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING A KNEE JOINT PROCEDURE, THE OMNISPAN MENISCAL REPAIR 27DEG DEVICE PULLED OUT AND THE MILAGRO ADVANCE SCREW 8X30MM AND MILAGRO ADVANCE SCREW 7X30MM DEVICES BROKE. 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 24250682 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 9 OF 10 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER DUA-SPORTS-2024-017 CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X30MM DEVICE FAILED AND THE PATIENT REQUIRED A RE-OPERATION OR REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22579348 ↗
• MalfunctionJun 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8 X 30 MM ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT 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 22161795 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTIVE SURGICAL PROCEDURE ON (B)(6) 2024, THE 8 X 30MM MILAGRO TAPERED SCREW DEVICE ANCHOR BROKE OFF, REMOVED ALL BROKEN PARTS. 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 19654702 ↗
• MalfunctionDec 20, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE SURGERY ON 12/12/2023 THE TRUESPAN DEVICE X2 COULD NOT FIRE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE MILAGRO ADVANCE SCREW 8X30MM DEVICE ANCHOR WAS BROKEN OFF WHEN THE ANCHOR WAS INSERTED, REMOVED ALL THE BROKEN PARTS. 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. THIS IS REPORT 2 OF 3 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18362439 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 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 18182251 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 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 8X30MM 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 17309028 ↗
• MalfunctionJul 25, 2022Break; Break

  THIS IS REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN CHINA THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT TWO PLATES ON THE TRUESPAN MENISCAL REPAIR SYSTEM PEEK 24 DEGREE DEVICE WAS DEPLOYED AT THE SAME TIME AFTER THE FIRST FIRING. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME THING HAPPENED AGAIN. SUBSEQUENTLY, TWO ANCHORS: 8X23MM MILAGRO ADVANCE INTERFERENCE SCREW AND 8X30MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICES BROKE OFF UPON INSERTION. 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 15095370 ↗
• 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 8X30MM 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 14991156 ↗
• MalfunctionMar 20, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X30MM DEVICE BROKE UPON INSERTION INTO THE TIBIAL TUNNEL. 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 13829464 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE VIA PERSONAL INTERACTION THAT ON (B)(6) 2020 THE (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT AN ACLR (ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION). GRAFTS WERE FIXATED WITH A MILAGRO 8X23 IN THE FEMORAL BURR HOLE. NEXT, OTHER GRAFTS WERE FIXATED IN THE TIBIAL BURR HOLE WITH THE MILAGRO ADVANCE 8X30 IN QUESTION. APPROXIMATELY TWO MONTHS PASSED WHEN INFLAMMATION APPEARED IN THE INCISION LESION OF THE TIBIA. THE SUTURE WAS REMOVED, AND THE LESION WAS RE-SUTURED, WHICH DID NOT CORRECT THE INFLAMMATION. FINALLY, MRI REVEALED SOME ABNORMALITIES SUCH AS AN ENLARGED BURR HOLE AROUND THE AREA WHERE THE MILAGRO ADVANCE 8X30 WAS INSERTED. GRAFT SURVIVAL WAS NOTICED TO A CERTAIN EXTENT. THE MILAGRO IN QUESTION HAD KEPT ITS ORIGINAL SHAPE. ON (B)(6) THE PATIENT UNDERWENT A REMOVAL PROCEDURE. CURRENTLY SHE IS UNDER MEDICAL FOLLOW-UP. ADDITIONAL INFORMATION COULD NOT BE PROVIDED BY THE AFFILIATE.

  Patient problems: Inflammation; No Code Available

  MAUDE report 10487037 ↗
• MalfunctionMay 11, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT BEFORE ARTHROPLASTY THE MILAGRO ADVANCE SCREW 8X30MM, THE SCREW COMES UNSTERILE THE FOIL WAS DEFECT. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10045236 ↗
• MalfunctionSep 17, 2019Break; Break

  ANCHOR WAS PULLED OUT. IT WAS REPORTED THAT DURING THE ACL RECONSTRUCTION, USED SCREW DRIVER TO INSERT THE ANCHOR, WHEN REMOVED THE DRIVER, THE SCREW ALSO WAS PULLED OUT. CHANGED ANOTHER SCREW, THE EVENT RE-HAPPENED. CHANGED ANOTHER SCREW WITH THIS DRIVER COULD INSENT ANCHOR SUCCESSFULLY. SO THE SURGEON SUSPECT IT IS RELATED THE ANCHORS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9079632 ↗
• MalfunctionJun 21, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE 8X30 MILAGRO ADVANCE SCREW BROKE WHEN SCREWED INTO THE CHANNEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8723260 ↗
• MalfunctionJan 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE WHILE INSERTING THE CUSTOMER'S 8 X 30MM MILAGRO TAPERED SCREW, THE SCREW BROKE. THE SCREW BROKE ON THE TIBIAL SIDE AND THAT A 30MM MODULAR DRIVER WAS USED WITH THE SCREW. THE SCREW WAS BEING INSERTED OVER A GUIDE WIRE. THE SURGEON REMOVED ALL THE BROKEN PIECES AND NO DEBRIS WAS LEFT IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH A 9 X 30MM SCREW USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288749 ↗
• MalfunctionJan 28, 2019Fracture; Fracture

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X30MM DEVICE BROKE DURING THE SCREW-INSERTION OVER THE GUIDE-WIRE WITH THE UNIVERSAL-SCREWDRIVER. IT WAS AN 7MM TIBIA-TUNNEL, WITH A SHORT DISTAL DRILL 8.5. THE SURGEON TOOK THE PIECES OUT AND INSERT A NEW ONE BUT IT ALSO BROKE. IT WAS REPORTED THAT THE SECOND ONE STAYED IN THE PATIENT AS THE SCREW BROKE NEAR THE SCREW-HEAD. IT WAS REPORTED THAT THE SECOND SCREW WAS INSERTED INTO THE SAME HOLE AS WELL. THERE WAS NO DELAY OF GREATER THAN 30 MINUTES IN THE SURGICAL PROCEDURE. 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 8281919 ↗
• MalfunctionJan 28, 2019Fracture; Fracture

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X30MM DEVICE BROKE DURING THE SCREW-INSERTION OVER THE GUIDE-WIRE WITH THE UNIVERSAL-SCREWDRIVER. IT WAS AN 7MM TIBIA-TUNNEL, WITH A SHORT DISTAL DRILL 8.5. THE SURGEON TOOK THE PIECES OUT AND INSERT A NEW ONE BUT IT ALSO BROKE. IT WAS REPORTED THAT THE SECOND ONE STAYED IN THE PATIENT AS THE SCREW BROKE NEAR THE SCREW-HEAD. IT WAS REPORTED THAT THE SECOND SCREW WAS INSERTED INTO THE SAME HOLE AS WELL. THERE WAS NO DELAY OF GREATER THAN 30 MINUTES IN THE SURGICAL PROCEDURE. 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 8281914 ↗
• MalfunctionOct 18, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X30MM DEVICE WAS BROKEN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 7977693 ↗
• MalfunctionAug 23, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, A MILAGRO ADVANCE SCREW (8X30 MM) HAS BEEN CRUMBLED INTO PIECES. THE CHANNEL WAS 7 MM. THE SCREW BROKE ON THE LAST PART OF INSERTION WHEN IT WAS NINETY PERCENTAGE (90%) INTO THE BONE TUNNEL. ALL BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SMALLER MILAGRO ADVANCE SCREW (8X23 MM). PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7811028 ↗