NA 254514Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886705013050), received between Apr 16, 2018 and Sep 10, 2026 — classified as 11 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721110 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT AFTER AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE WHILE USING THE ABSOLUTE G-W NTNL DEVICE IT WAS OBSERVED THAT THE NEEDLE HAD BEEN FRACTURED, WITH HALF OF IT REMAINING INSIDE THE PATIENT. THE SITUATION WAS DETECTED ONLY THE FOLLOWING DAY, WHEN THE PATIENT WAS X-RAYED, AT WHICH TIME THE ABSENCE OF THE OTHER HALF OF THE NEEDLE WAS FOUND. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23096275 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A HAMSTRING ANTERIOR CRUCIATE LIGAMENT PROCEDURE, IT WAS DISCOVERED THAT THE PIN TIP OF THE NITINOL GUIDEWIRE 1.1MM X 38.1CM (15 INCHES) DEVICE BROKE OFF IN THE GRAFT WITHIN THE PATIENT'S TIBIA. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE AT THE 30 MM LINE, BREAKING THE 10×30 SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AN X-RAY WAS USED TO DETERMINE PIN PLACEMENT, AND THE GRAFT HAD TO BE CUT OUT AND REDONE WITH A NEW BUTTON AND SCREW. THERE WAS TWENTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. NO INJURIES WERE REPORTED, BUT THERE WAS MEDICAL INTERVENTION REQUIRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076845 ↗
• InjuryAug 15, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP AFTER A BONE TENDON BONE AUTOGRAFT ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGICAL PROCEDURE ON (B)(6) 2024 THE ABSOLUTE G-W NTNL 1.1MMX15 6PK DEVICE GUIDEWIRE 1.1MM X 15 WAS THE NITINOL WIRE BROKEN WHILE INSERTING THE TIBIAL ACL SCREW. THE CASE WAS COMPLETED SUCCESSFULLY, BUT A PIECE OF METAL FROM THE NITINOL WIRE WAS LEFT IN THE PATIENT. THE PATIENT HAD TO COME BACK FOR A SECOND SURGERY BECAUSE OF METAL LEFT BEHIND IN THE BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19991167 ↗
• InjuryOct 4, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, A GUIDEWIRE 1.1MM X 15¿ DEVICE WAS USED. ACCORDING TO THE REPORT, THE DEVICE RUPTURED WHEN DESCENDING THE FEMORAL INTERFERENCE SCREW THAT CAUSED A PERMANENT CESSATION OF OPERATION OR CANCELLATION OF THE PROCEDURE. IT WAS REPORTED THAT THERE WERE FRAGMENTS OF GUIDEWIRE NITINOL PERSISTED INTRAARTICULARLY WHICH REQUIRED ADDITIONAL ABLATION VIA OBSTRUCTION; AND A SECOND PROCEDURE WHICH WAS NOT SPECIFIED WHETHER IT WAS ALREADY SCHEDULED OR WAS SCHEDULED OUT OF NECESSITY FOLLOWING THE INCIDENT. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17871730 ↗
• MalfunctionApr 3, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO NITINOL GUIDEWIRES BROKE WHILE INSERTING THE MILAGRO INTERFERENCE SCREW. ACCORDING TO THE REPORT, DURING THE INSERTION OF THE SCREW, THE NITINOL GUIDWIRE WAS STOPPED WITH A SPOON INSIDE OF THE JOINT, SO IT WAS VISIBLE DURING THE WHOLE INSERTION OF THE SCREW. REMOVED THE BROKEN PART OF THE NITINOL GUIDEWIRE AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 60 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667789 ↗
• MalfunctionApr 3, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO NITINOL GUIDEWIRES BROKE WHILE INSERTING THE MILAGRO INTERFERENCE SCREW. ACCORDING TO THE REPORT, DURING THE INSERTION OF THE SCREW, THE NITINOL GUIDWIRE WAS STOPPED WITH A SPOON INSIDE OF THE JOINT, SO IT WAS VISIBLE DURING THE WHOLE INSERTION OF THE SCREW. REMOVED THE BROKEN PART OF THE NITINOL GUIDEWIRE AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 60 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665854 ↗
• MalfunctionNov 10, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN THE UNITED KINGDOM THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE GUIDEWIRE 1.1MM X 15¿ DEVICE SNAPPED OFF INTO FEMUR. ACCORDING TO THE REPORT, THE 0.5CM PIECE WAS STUCK IN THE SCREW AND THE SURGEON LEFT IT IN THE PATIENT AS IT WOULD HAVE BEEN MORE HARM TO THE PATIENT IF HE HAD REMOVED IT. THERE WAS A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15774609 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ABSOLUTE GW NTNL 1.1MMX15 6PK GUIDE WIRE DEVICE BROKE DURING REMOVAL AND AFTER MILAGRO SCREW INSERTION. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DELAY AS AN EXTRA INCISION WAS REQUIRED TO REMOVE THE BROKEN WIRE. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11849029 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT A GUIDEWIRE 1.1MM X 15¿ DEVICE BROKE DURING INSERTION OF FEMORAL MILAGRO SCREW. THE BROKEN WIRE WAS DIFFICULT TO REMOVE AFTER THE SCREW WAS INSERTED AND AN EXTRA INCISION WAS REQUIRED TO REMOVE THE WIRE. THERE WAS A SURGICAL DELAY OF 10-15 MINUTES TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11848804 ↗
• MalfunctionMay 19, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT A GUIDEWIRE 1.1MM X 15¿ DEVICE WAS BENT AND ALMOST BROKE APART COMPLETELY DURING INSERTION OF FEMORAL MILAGRO SCREW. THE WIRE WAS DIFFICULT TO REMOVE AFTER THE SCREW WAS INSERTED THAT IT DELAYED THE SURGERY BY TWO MINUTES TO BE COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848758 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION OF THE RIGHT KNEE PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ABSOLUTE G-W NTNL 1.1MMX15 6PK GUIDEWIRE DEVICE SPLIT AS THE SURGEON WAS THREADING THE SCREW INTO THE BONE. ALL FRAGMENTS WERE REMOVED. THERE WAS A DELAY OF 20 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740406 ↗
• InjuryApr 28, 2021Break; Break

  IT WAS REPORTED BY AFFILIATE IN (B)(6) THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2021, IT WAS OBSERVED THAT A FRAGMENT OF THE ABSOLUTE G-W NTNL 1.1MMX15 6PK DEVICE REMAINED INSIDE THE PATIENT AND BEGAN TO COME OUT LITTLE BY LITTLE THROUGH THE CANNULATION OF THE IMPLANTED SCREW DEVICE. ON (B)(6) 2021, THE PATIENT UNDERWENT ANOTHER SURGICAL INTERVENTION TO EXTRACT THE FRAGMENT. THE PATIENT PRESENTED INFLAMMATION. THE FRAGMENT WAS REMOVED FROM THE PATIENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Inflammation

  MAUDE report 11740338 ↗
• MalfunctionDec 28, 2020Break; Break

  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 WHILE USING GUIDEWIRE 1.1 MM X 15¿ BROKE AND RIGIDLOOP DISPOSABLE KIT, A NITINOL WIRE WAS FOUND TO BE BROKEN AFTER ADVANCING SCREW IN. INTERVENTIONAL IMAGING WAS DONE TO RETRIEVE BROKEN PART OF THE WIRE. BROKEN WIRE WAS RETRIEVED SUCCESSFULLY. NO FRAGMENT LEFT IN PATIENT. THERE WAS A SURGICAL DELAY OF 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11082157 ↗
• InjuryOct 20, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: DURING SURGERY, WHILE THE INTERFERENCE SCREW WAS PLACED USING THE NITINOL PIN, IT BROKE WHEN THE SCREWDRIVER WAS REMOVED AND REMAINED INSIDE THE SCREW THAT WAS IMPLANTED IN THE PATIENT. ANOTHER PIN WAS PASSED TO COMPLETE THE SURGERY. THE PIN WAS LEFT IN THE SCREW THAT WAS IMPLANTED IN THE PATIENT. THE STATUS OF THE PATIENT IS UNKNOWN. NO SURGICAL DELAY. THE DEVICE IS AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED PATIENT COMPLICATIONS WERE NOT REPORTED AND A REMOVAL PROCEDURE HAS NOT BEEN SCHEDULED. IT WAS ALSO REPORTED THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10707491 ↗
• InjurySep 18, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL, THE ABSOLUTE G-W NTNL 1.1MMX15 6PK. THE PROCEDURE WAS AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. WHEN THE PATIENT WENT TO THE CONTROL, HE EXPRESSED THAT HE HAD PAIN. UPON EXAMINATION, THE DOCTOR DETECTED A LUMP, SUBJECTED IT TO AN X-RAY AND IT WAS DETECTED THAT A FRAGMENT OF THE NITINOL GUIDE HAD REMAINED. I DO NOT KNOW HOW MUCH TIME PASSED BETWEEN THE CONSULTATION AND THE REMOVAL OF THE MATERIAL. THE PATIENT DID NOT PRESENT ANY TYPE OF ADVERSE REACTION AND THE FRAGMENT COULD BE REMOVED SUCCESSFULLY. ACCORDING TO THE TECHNICAL ASSISTANT, THE NITINOL GUIDE IN QUESTION WAS NOT OURS BUT THE DOCTOR'S OWN. THE PATIENT HAD TO UNDERGO A MINOR SURGICAL PROCEDURE. THERE WAS INFLAMMATION AND PAIN. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient; No Code Available; Pain; Swelling; Swelling/ Edema

  MAUDE report 10557552 ↗
• InjuryFeb 5, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE SPECIALIST PERFORMED A PROCEDURE WITHOUT ANY COMPLICATION IN THE SURGICAL TECHNIQUE OF THE CREATION OF THE 10 MM FEMORAL AND TIBIAL TUNNELS. THE SPECIALIST PASSES THE HTH BONE BANK GRAFT AND PROCEED TO THE FEMORAL FIXATION WITH THE ABSOLUTE G-W NTNL 1.1 MMX15 6PK, BEFORE PASSING THE SCREW, THE NITINOL PIN IS PASSES, THAN THE PIN IS REMOVED AND ITS OBSERVED THAT THE EXTREME PART OF THE PIN WAS SPLIT INSIDE THE PATIENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. ADDITIONAL INFORMATION: SAMPLE OF THE PIN THAT WAS LEFT TO THE CLS STORE IS SENT TO QUARANTINE, THE PIECE WAS MARKED AND WAS LEFT IN THE REPORT BAG ADVERSE EVENT, DECONTAMINATED AND CLEAN.

  Patient problems: Foreign Body In Patient

  MAUDE report 9672631 ↗
• MalfunctionDec 18, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT A GUIDEWIRE 1.1 MM X 15¿ DEVICE BROKE IN THE BONE CANAL WHILE SCREWING A MILAGRO ANCHOR DEVICE. IT WAS REPORTED THAT ALL OF THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. 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 9488548 ↗
• MalfunctionNov 15, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN ACL CASE THE PINS OF THE ABSOLUTE G-W NTNL 1.1MMX15 6PK BROKE, THE BROKEN TIP WAS TRAPPED IN THE GRAFT AND THE SURGEON HAD TO REMOVE THE MILAGRO ADVANCE SCREW 11X30MM AND THE CORTICAL FXATION FXD LOOP 15MM FROM FEMORAL SIDE IN ORDER TO TAKE THE GRAFT OUT AND LOOKED FOR THE WIRE TIP, THE GUIDE WIRE TIP WAS FOUND AND WAS REMOVED FROM THE PATIENT, BUT THE SCREW WAS A LITTLE DEFORMED. THE PROCEDURE WAS COMPLETED USING DIFFERENT DEVICES. NO PATIENT CONSEQUENCE WAS REPORTED. HOWEVER, THERE WAS A SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED A 30 MINUTE SURGICAL DELAY. THE AFFILIATE ALSO REPORTED ONLY ONE FRAGMENT WAS GENERATED AND IT WAS SUCCESSFULLY REMOVED BY THE SURGEON. IT WAS ALSO REPORTED THE BROKEN TIP WAS TRAPPED IN THE GRAFT AND SURGEONS NEED TO REMOVE THE 231824 AND 15MM RIGIDLOOP 232009 X1 (LOT 4L23984) AT FEMORAL SIDE IN ORDER TO TAKE THE GRAFT OUT AND SEARCH FOR THE GUIDE WIRE TIP. THE AFFILIATE REPORTED THAT NORMAL FORCE WAS APPLIED TO REMOVE THE SCREW.

  Patient problems: Not Applicable

  MAUDE report 9330829 ↗
• MalfunctionOct 8, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT AFTER SCREWING THE ABSOLUTE G-W NTNL 1.1MM X 15 6PK ACCORDING TO THE PROCEDURE AND CHECKING THE BROACH,WHEN REMOVING THE GUIDE BROACH, THE DISTAL END WAS BROKEN AT THE FIRST MARK. DURING THE AMPLI CONTROL, VIEWING OF THE BROACH FRAGMENT IN THE EXTERNAL FEMORAL CONDYLE. DECISION TO REMAIN IT IN PLACE. IMPLANTATION OF A NEW BROACH AND A NEW SCREW WITHOUT ANY PROBLEM. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE DEVICE WAS PURCHASED BY THE HOSPITAL. IT WAS ALSO REPORTED IT WAS DECIDED THAT THE FRAGMENT BROACH REMAIN RETAINED ON THE EXTERNAL FEMORAL CONDYLE AND IMPLANT A NEW BROACH, WHICH ALLOWED FOR SUCCESSFUL COMPLETION OF THE PROCEDURE. A SURGICAL DELAY OF A FEW MINUTES WAS REPORTED AND ANSM DECELERATION WAS NOT REQUIRED. THE AFFILIATE REPORTED THAT IS UNKNOWN IF A NEW SURGERY WILL BE REQUIRED TO REMOVE THE BROKEN BROACH AND THE LOT NUMBERS OF THE BROACH AND SCREWS ARE UNKNOWN. IT WAS REPORTED THAT THE DEVICE WILL NOT BE RETURNING FOR EVALUATION AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL BUT WILL REQUIRE A CONSULTATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 9167347 ↗
• InjuryJul 31, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA CST TOOL THAT A PATIENT WAS SCHEDULED FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION BY ARTHROSCOPY. IT WAS TECHNICALLY PERFORMED BY ANTEROMEDIAL PORTAL. A MIRACLE INTERFERENCE SCREW WAS USED FOR THE FIXATION OF THE GRAFT IN THE TIBIAL TUNNEL. THE EVENT OCCURRED AT THE TIME OF REMOVING THE NITINOL GUIDE THAT IS USED TO PLACE THE INTERFERENCE SCREW. THE NITINOL GUIDE BROKE AND A 3-CENTIMETER FRAGMENT REMAINED IN THE PATIENT. THE FRAGMENT COULD BE REMOVED SMOOTHLY WITHOUT ANY ADDITIONAL INTERVENTION. THE SURGICAL TIME INCREASED BY 20 MINUTES. THE ORTHOPEDIST DEMANDS NO ANSWER. THERE WERE NO PATIENT CONSEQUENCES REPORTED AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTING THE CASE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LIKE DEVICE.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 8846595 ↗
• InjuryApr 5, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA E-MAIL THAT DURING A SURGERY A NITINOL GUIDE WAS USED FOR THE PLACEMENT OF A MIRACLE SCREW. WHILE REMOVING THE GUIDE, A PIECE WAS MISSING LEAVING THE FRAGMENT IN THE PATIENT. THE SPECIALIST REVIEWED THE SITUATION AND DID NOT CAUSE DISCOMFORT OR INCREASE THE TIME OF SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8487920 ↗
• MalfunctionMar 29, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING ACL SURGERY WHEN FIXATING ON THE TIBIAL SIDE WITH MILAGRO ADVANCE (TUNNEL 8.5 MM, SCREW 9X30 MM) EVERYTHING WENT PERFECT UNTIL THE SURGEON WAS REMOVING THE DRIVER AND THE GUIDE WIRE. THE GUIDE WIRE WAS BROKEN AND ONE PIECE WAS LEFT IN THE KNEE. HE GOT THE PIECE OUT (AFTER SOME TROUBLE) AND THE SURGERY WAS FINISHED. THERE WAS NO PATIENT HARM REPORTED AND THE SURGERY WAS PROLONGED APPROXIMATELY 20 MINUTES. THEY WERE NOT SURE IF THE PROBLEM IS ALSO INSIDE THE DRIVER.

  Patient problems: Not Applicable

  MAUDE report 8464482 ↗
• MalfunctionNov 6, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SURGICAL PROCEDURE FOR A RUPTURED ANTERIOR CRUCIATE LIGAMENT, IT WAS OBSERVED THAT THE GUIDE-WIRE AND THE MILAGRO-SCREW BROKE UPON INSERTION OF THE TIBIAL SCREW. IT WAS REPORTED THAT THE SURGERY WAS PROLONGED BY FOUR MINUTES BUT NEW SCREWS AND NEW WIRE WERE USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT EVERYTHING WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT ALL DEVICES HAVE BEEN DISCARDED BY THE CUSTOMER. 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: Not Applicable

  MAUDE report 8041446 ↗
• InjuryApr 16, 2018Break; Break

  THE BONE WAS GOOD QUALITY. THE IMPLANT WAS LEFT IN THE PATIENT AND THE HOLE OR DRILL HOLE WAS USED AND IT WAS A 10MM, IT WAS A METAL SCREW THAT WAS USED AND EVERYTHING WAS NORMAL JUST SMALL TIP WAS LEFT IN WITH METAL SCREW.

  Patient problems: Foreign Body In Patient

  MAUDE report 7434250 ↗