NA 232300Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886705011117), received between May 9, 2018 and Sep 15, 2026 — classified as 13 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 16, 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.

• InjurySep 15, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50780043 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGERY, WHILE USING THE ACL ACC DISPOSABLES KIT EA DEVICE THE GUIDEWIRE IN A DISPOSABLE KIT FOR ANTERIOR CRUCIATE LIGAMENT REPAIR FRACTURED AND BROKE WHILE SURGEON WAS PERFORMING PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25314797 ↗
• InjuryApr 24, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGERY WITH AN ACL ACC DISPOSABLES KIT, THE PATIENT RETURNED LATER IN THE WEEK FOR FOLLOW UP AND THEY FOUND THE NITINOL WIRE FROM THE ANTERIOR CRUCIATE LIGAMENT KIT WAS BROKEN OFF AND STILL IN THE KNEE JOINT SPACE POSTOPERATIVE. THEY BROUGHT THE PATIENT BACK IN LATER LAST WEEK TO REMOVE THE BROKEN NITINOL WIRE. THERE WAS A MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Insufficient Information

  MAUDE report 24987680 ↗
• InjuryAug 8, 2025Break; Break

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, DURING A FOLLOW APPOINTMENT THE XRAY SHOWED A SMALL PIECE OF GUIDEWIRE FROM THE ACL ACC DISPOSABLES KIT EA DEVICE HAD BROKEN OFF. THE PATIENT EXPERIENCED PAIN AND UNKNOWN LONG-TERM COMPLICATIONS. A SECOND PROCEDURE WAS PERFORMED TO REMOVE THE GUIDEWIRE SUCCESSFULLY. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 22749922 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING THE ACL ACC DISPOSABLES KIT EA DEVICE THE USER NOTICED METALLIC DEBRIS WHILE DRILLING WITH THE BAYONET POINT PASSING PIN THROUGH THE ANTEROMEDIAL FEMORAL AIMER. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE PROCEDURE AS COMPLETED SUCCESSFULLY. THEY COULD REMOVE THE METALLIC FRAGMENTS WITH THE SHAVER. 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 22215675 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A MEDIAL COLLATERAL LIGAMENT PROCEDURE SURGICAL PROCEDURE ON (B)(6) 2024 THE ACL ACC DISPOSABLES KIT EA DEVICE NITINOL WIRE BROKE OFF IN PATIENT WHEN PUTTING THE MILAGRO SCREW IN ON THE LATERAL SIDE OF KNEE USING AN UNKNOWN IMPLANT. THE SCREW BROKE AS WELL. THE SCREW WAS PUT IN ON POWER. ADDITIONAL X-RAYS WERE TAKEN TO FIND SMALL PIECES OF THE PIN AND HAD TO FISH IT OUT WITH EXTRA TOOLS. DURING THIS PROCESS THE SURGEON WAS CUT BY THE PIN. THE PIECE WAS EVENTUALLY REMOVED. THERE WAS A DELAY OF FIVE MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS EVENT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257792 ↗
• InjuryJun 3, 2024Break; Break

  THIS IS REPORT 2 OF 2 FOR(B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE GUIDE WIRES FROM TWO (2) ACL DISPOSABLES KIT DEVICES BROKE INSIDE THE PATIENT. THERE WAS A DELAY IN THE SURGICAL PROCEDURE; HOWEVER, THE DURATION WAS NOT SPECIFIED. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. HOWEVER, FRAGMENTS WERE GENERATED IN THE PATIENT. IT WAS REPORTED THAT THE PATIENT WOULD HAVE TO UNDERGO A PROCEDURE FOR REMOVAL OF THE FRAGMENTS. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE PATIENT CONSEQUENCES AS A RESULT OF THIS EVENT. THERE WERE REPORTS OF INJURIES, MEDICAL INTERVENTION AND /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: Unspecified Tissue Injury

  MAUDE report 19448568 ↗
• InjuryJun 3, 2024Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE GUIDE WIRES FROM TWO (2) ACL DISPOSABLES KIT DEVICES BROKE INSIDE THE PATIENT. THERE WAS A DELAY IN THE SURGICAL PROCEDURE; HOWEVER, THE DURATION WAS NOT SPECIFIED. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. HOWEVER, FRAGMENTS WERE GENERATED IN THE PATIENT. IT WAS REPORTED THAT THE PATIENT WOULD HAVE TO UNDERGO A PROCEDURE FOR REMOVAL OF THE FRAGMENTS. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE PATIENT CONSEQUENCES AS A RESULT OF THIS EVENT. THERE WERE REPORTS OF INJURIES, MEDICAL INTERVENTION AND /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: Unspecified Tissue Injury

  MAUDE report 19448561 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED BY SALES REP THAT BEFORE AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE ACL DISPOSABLES KIT WAS SPLIT DOWN THE MIDDLE. 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 18695662 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE ON (B)(6) 2023 THE ACL ACC DISPOSABLES KIT DEVICE HAD A BROKEN PIECE OF NITINOL WIRE LEFT IN THE PATIENT SINCE IT WAS EMBEDDED IN THE FEMORAL TUNNEL BEHIND AM ANTERIOR CRUCIATE LIGAMENT GRAFT AND MILAGRO SCREW. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18011535 ↗
• MalfunctionJul 13, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE NITINOL GUIDE FROM THE ACL DISPOSABLE KIT BROKE DURING INSERTION OF A MILAGRO ADVANCE 7X23 DEVICE. ACCORDING TO THE REPORT, THE SURGEON INSERTED THE SCREW AS USUAL AND THEN WANTED TO TAKE NITINOL GUIDE AWAY. IT WAS REPORTED THAT THE SURGEON HAD TO PULL FIRMLY AS THE GUIDE WAS HARD BUT BROKE IN THE PROCESS. IT WAS REPORTED THAT 1 CM OF THE TIP WAS MISSING. IT WAS REPORTED THAT THE SURGEON DID NOT SEE THE POINT OF THE NITINOL GUIDE SO HE LEFT IT MISSING AND THOUGHT THAT IT IS MAYBE IN THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF THREE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15006440 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL STUDY REPORT: EVALUATION OF HEALTHCARE OUTCOMES OF PATIENTS UNDERGOING ARTHROSCOPIC ACL RECONSTRUCTION USING DEPUY SYNTHES ACL DISPOSABLES KIT OR TWISTR¿ RETROGRADE REAMER. SOFT TISSUE INJURY AND INFECTION HAD BEEN IDENTIFIED AS THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: ACL DISPOSABLES KIT . PROD. #232300. 28 UNKNOWN PATIENTS REQUIRED REVISION SURGERY WITHIN 90 DAYS OF THEIR PRIMARY PROCEDURE.

  Patient problems: Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14014526 ↗
• MalfunctionFeb 9, 2022Break; Entrapment of Device

  DURING A LEFT KNEE ARTHROSCOPY & ACL REPAIR THE GUIDEWIRE, APPROXIMATELY 6.5CM BROKE AND REMAINED IN THE PATIENT'S KNEE. THIS EVENT WAS NOT DISCOVERED UNTIL THE PATIENT'S FIRST POST OPERATIVE APPOINTMENT WHERE AN X-RAY WAS COMPLETED AND THE FOREIGN BODY WAS DISCOVERED. THE PATIENT WAS THEN RESCHEDULED FOR A KNEE ARTHROSCOPY AND FOREIGN BODY REMOVAL. DURING THE PROCEDURE, THE PATIENT TOLERATED THE PROCEDURE WELL. THE GUIDEWIRE WAS REMOVED WITHOUT RESISTANCE. THE SURGEON STATED THAT THE PATIENT DID NOT HAVE POST OPERATIVE COMPLAINTS OF PAIN OUTSIDE OF NORMAL PARAMETERS OF THE PATIENT'S SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13497386 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGERY ON (B)(6) 2022 WHILE USING THE ACL ACC DISPOSABLES KIT DEVICE, IT WAS OBSERVED THAT THE TIP OF THE GUIDEWIRE IN THE BROKE OFF AND ENDED UP STUCK IN THE SCREW. ACCORDING TO THE REPORT, THE EVENT WHEN THE GUIDEWIRE WAS PULLED AS IT WAS STUCK IN THE SCREW AFTER DRIVING THE SCREW IN THE FEMORAL SOCKET. THE OTHER END OF THE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13386633 ↗
• InjuryJan 13, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT A NITINOL WIRE SHEERED OFF WHILE IMPLANTING THE INTERFERENCE SCREW ON THE ACL ACC DISPOSABLES KIT DEVICE. ACCORDING TO THE REPORT, THE BROKEN WIRE WAS NOT NOTICED BY ANYONE AND WAS NOT SEEN WHEN TAKING FINAL VISUALIZATION OF THE ACL. IT WAS REPORTED THAT THE PATIENT CAME TO SEE THE SURGEON AFTER SURGERY COMPLAINING OF KNEE PAIN AND AN XRAY CONFIRMED THERE WAS A PIECE OF WIRE INSIDE THE JOINE. IT WAS REPORTED THAT A FOLLOW UP PROCEDURE HAD TO BE DONE TO RETRIEVE THE RETAINED BROKEN WIRE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13252831 ↗
• MalfunctionJun 10, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 1.1MM STERILE GUIDEWIRE OFF THE ACL ACC DISPOSABLES KIT DEVICE SNAPPED WHILE REMOVING THE SCREWDRIVER FROM THE TIBIA WHERE A MILAGRO ADVANCE DEVICE WAS IMPLANTED. THE WIRE WAS FOUND THROUGH X- RAY AND WAS REMOVED WHICH CAUSED A DELAY OF 20 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11976106 ↗
• MalfunctionMay 24, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  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 RESTORE FEMORAL AIMER 6 MM OFFSET WAS SCOURING DRILL TIP PASSING PIN (THAT COMES IN ACL DISPOSABLE KIT) DURING DRILLING THAT METAL FRAGMENTS WERE CREATED. THE PROCEDURE WAS COMPLETED USING NORMAL TECHNIQUE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872087 ↗
• MalfunctionOct 30, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE ACL DISPOSABLES KIT BROKE DURING INSERTION. THE PHYSICIAN MENTIONED THAT HE NOTICED A BENT BEFORE INSERTION. ALL FRAGMENTS WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10760125 ↗
• MalfunctionMay 15, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE GUIDEWIRE FROM THE ACL DISPOSABLE KIT BROKE, ALL THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT´S BODY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT CONSEQUENCES REPORTED. 30 MINUTES DELAY. THE DEVICE WAS DISCARDED BY THE STAFF. ADDITIONAL INFORMATION PROVIDED BY THE SALES REPRESENTATIVE REPORTED THE DEVICE BROKE WHEN THE DOCTOR WAS AT THE POINT IN THE CASE WHERE HE WAS READY TO FIXATE THE ACL HAMSTRING AUTOGRAFT IN THE TIBIAL TUNNEL. IT WAS REPORTED HIS TECHNIQUE IS TO INSERT A NITINOL GUIDEWIRE (FROM THE ACL DISPOSABLES KIT # 232300) INTO THE TIBIAL TUNNEL, BETWEEN THE BONE AND GRAFT BUNDLE. HE THEN INSERTS THE MILAGRO ADVANCE SCREW OVER THE GUIDEWIRE AND ADVANCES THE SCREW UNTIL FULLY SEATED. UPON SEATING THE SCREW HE REMOVED THE DRIVER OFF OF THE NITINOL GUIDEWIRE AND THEN PULLED THE GUIDEWIRE OUT BY HAND. UPON REMOVING THE GUIDEWIRE IT WAS WHEN HE NOTICED THE TIP OF THE GUIDEWIRE WAS BROKEN. IT WAS NOT THE NORMAL LENGTH BEFORE INSERTION AND WE KNEW THIS BY LOOKING FOR THE BLACK LASER MARK THAT IS NEAR THE END OF THE GUIDEWIRE ON EACH SIDE. HE THEN PUT THE SCOPE BACK IN TO LOOK FOR THE FR

  Patient problems: Not Applicable

  MAUDE report 10063127 ↗
• InjuryMar 17, 2020Break; Break

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT A DRILL BIT OR PIN BROKE AND WAS LEFT IN THE PATIENTS LEG DURING AN ACL SURGERY ON (B)(6) 2019. THIS WAS NOT NOTICED UNTIL A FOLLOW UP APPOINTMENT AT DR'S OFFICE. THE SALES REP STATES THEY CANNOT CONFIRM THE IDENTITY OF DEVICE, BUT DUE TO IT CAN BE SEEN TROUGH X-RAY, AND BASED ON REP'S KNOWLEDGE, IT APPEARS TO BE THE DRILL TIP GUIDE PIN FROM AN ACL DISPOSABLES KIT. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE EVENT OCCURRED ON (B)(6) 2019 AND THEY CONFIRMED THE PART USED DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9842622 ↗
• InjuryFeb 27, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL THE GUIDE WIRE OF THE ACL DISPOSABLE KIT BROKE. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT´S BODY. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION REPORTED THE CASE WAS COMPLETED. IT WAS REPORTED NITINOL GUIDE-WIRE BROKE WHEN REMOVING THE WIRE AFTER MILAGRO SCREW INSERTION. NO NEED FOR ALTERNATIVE PRODUCT. SCREW STAYED IN. THEY USED X-RAY TO LOCATE AND REMOVE GUIDE-WIRE. ALL PIECES WERE REMOVED..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9764924 ↗
• InjuryAug 14, 2019Break; Break

  FURTHER IT WAS REPORTED THAT PATIENT HAD HARD BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8893301 ↗
• MalfunctionMay 22, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S ACL DISPOSABLE KIT GUIDE WIRE TIP BROKE OFF INSIDE THE PATIENT. THE SALES REP STATED THAT WHILE INSERTING THE SCREW APPROXIMATELY A FOUR-FIVE CENTIMETER PIECE BROKE IN THE PATIENT. THE CASE WAS COMPLETED BY REMOVING THE TIP OF THE WIRE USING A C-ARM AND A HEMOSTAT AND FOLLOWING THROUGH WITH THE REMAINDER OF THE PROCEDURE. THE SALES REP STATED ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS NO PATIENT HARM, BUT A TWENTY MINUTE DELAY TO REMOVE THE WIRE TIP AND FINISH THE CASE. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Not Applicable

  MAUDE report 8631511 ↗
• InjuryFeb 4, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT FOLLOWING AN ACL RECONSTRUCTION PROCEDURE DURING THE POST-OPT X-RAY, IT WAS NOTICED THAT THE SALES REP'S ACL DISPOSABLE KIT GUIDE WIRE TIP BROKE OFF IN THE PATIENT DURING THE CASE. THE SALES REP STATED THAT THERE IS APPROXIMATELY A 15MM PIECE OF THE GUIDE WIRE IN THE PATIENT'S FEMUR. THE CASE WAS COMPLETED WITH THIS KIT WITH NO TIME DELAY. THE SALES REP STATED THERE IS NO PLAN FOR SURGICAL INTERVENTION. THE GUIDE WIRE TIP REMAINS IN THE PATIENT, WHILE THE REMAINDER OF THE ACL DISPOSABLE KIT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 8301187 ↗
• InjuryOct 18, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL PROCEDURE THE 2.4MMX18 BEATH PIN IN THE CUSTOMER'S ACL DISPOSABLE KIT BROKE IN HALF WHEN THE SURGEON WAS TRYING TO DRILL THRU THE FEMUR. THE BROKEN PIECE WAS REMOVED WITH A PAIR OF PLIERS WITH NO ISSUES. THE SALES REP STATED THAT THE PATIENT WAS OVERWEIGHT AND THE SURGEON HAD TO USE EXCESSIVE FORCE IN SMALL SPACES TO CREATE LARGER TUNNELS. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S PRODUCT WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. POST TO THE PROCEDURE THE SALES REP WAS MADE AWARE ON APRIL 19TH THAT THE 1.1MMX15 NITINOL GUIDEWIRE FROM THE KIT ALSO HAD BROKEN IN THE PATIENT DURING THE SAME CASE BUT WAS FOUND AFTER THE PROCEDURE. THE PIECE OF GUIDEWIRE WAS REMOVED FROM THE PATIENT IN A SEPARATE CASE WITH NO ISSUES. UNKNOWN WHAT DATE THE GUIDEWIRE WAS REMOVED FROM THE PATIENT. THE SALES REP CONFIRMED THAT THE PATIENT'S CURRENT CONDITION IS FINE. THE SALES REP STATED THAT BOTH DEVICES WERE DISCARDED BY THE CUSTOMER. IT WAS CLARIFIED THAT TWO PARTS OF THE ACL DISPOSABLE KIT BROKE DURING THE CASE. THE SURGEON REPORTED THAT THE PATIENT HAS EXTREMELY HARD BONE UNDERGOING AN ACL REPAI

  Patient problems: Foreign Body In Patient; Tissue Damage

  MAUDE report 7978343 ↗