NA 254686Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886705013678), received between Jun 27, 2017 and May 19, 2025 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ANTEROMEDIAL FEMORAL AIMER DEVICE WAS BROKEN, THE AIMING ARM WAS BENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046887 ↗
• MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE ANTEROMEDIAL FEMORAL AIMER 6.5MM DEVICE WAS NOT CONSISTENT WITH THE LOT NUMBER THAT WAS ETCHED ON IT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 20220932 ↗
• MalfunctionJul 26, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT WHEN PREPARING FOR STERILIZATION, IT WAS OBSERVED THAT THE ANTEROMEDIAL FEMORAL AIMER 6.5MM WAS CHIPPED AND WAS JAGGED AT THE END OF THE GUIDE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397418 ↗
• MalfunctionMar 10, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANTEROMEDIAL FEMORAL AIMER 6.5MM DEVICE PRODUCED METAL SHAVINGS. ACCORDING TO THE REPORT, THEY USED A SHAVER TO EXTRACT METAL SHAVINGS, IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED 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 16522245 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON IN THAT DURING AN UNKNOWN SURGERY ON AN (B)(6) 2022, IT WAS OBSERVED THAT THE ANTEROMEDIAL FEMORAL AIMER 6.5MM DEVICE WAS SHEDDING METAL PARTICULATES IN THE KNEE JOINT. ALL THE METAL PARTICULATES WERE REMOVED AND 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 13624653 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE ANTEROMEDIAL FEMORAL AIMER 6.5MM DEVICE WAS SHEDDING METAL PARTICLES INTO THE PATIENT. 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 12658111 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE ANTEROMEDIAL FEMORAL AIMER 6.5MM DEVICE WAS SHEDDING METAL PARTICLES INTO THE PATIENT. 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 12658110 ↗
• MalfunctionApr 30, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANTEROMEDIAL FEMORAL AIMER 6.5MM DEVICE WAS SHEDDING METAL. ALL FRAGMENTS WERE REMOVED. 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 11753009 ↗
• MalfunctionSep 18, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING AN ACL RECONSTRUCTION, AN ANTEROMEDIAL FEMORAL AIMER 6.5MM WAS DAMAGED INSIDE THE SHAFT. SURGEON WAS DRILLING WITH THE 2.4MM DRILL PIN FROM THE RIGIDLOOP DISPOSABLE. WHEN DRILLING THERE WAS METAL DEBRIS COMING FROM THE DRILL BIT. SURGEON THINKS DRILL GUIDE MAY BE BENT. METAL PARTICLE WAS REMOVED USING THE ARTHROSCOPIC SHAVER AND PROCEDURE WAS COMPLETED. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10557457 ↗
• MalfunctionOct 8, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE WHEN USING THE BEATH PIN IN THE CUSTOMER'S RIGIDLOOP DISPOSABLE SYSTEM METAL SHAVINGS WERE CREATED. THE SURGEON STOPPED USING THE PIN AND REMOVED THE METAL SHAVINGS WITH THE SUCTION FROM THE SHAVER. THE SURGEON OPENED ANOTHER RIGIDLOOP DISPOSABLE SYSTEM STARTED TO USE THE BEATH PIN AND HALFWAY INTO USING THE PIN IT WAS NOTICED THAT METAL SHAVING WERE CREATED. THIS IS WHEN THEY REALIZED THAT THE CUSTOMER'S ANTEROMEDIAL FEMORAL AIMER 6.5MM THAT WAS BEING USED WITH THE PINS HAS A SPUR ON IT CAUSING THE PINS TO CREATE METAL SHAVINGS. THE SURGEON REMOVED THE METAL SHAVINGS AGAIN WITH THE SUCTION FROM THE SHAVER. THE PROCEDURE WAS COMPLETED WITH ANOTHER AIMER AND THE SECOND DISPOSABLE SYSTEM. THERE WAS NO PATIENT HARM BUT THERE WAS A FIVE MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP CONFIRMED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE AIMER. THE DISPOSABLE SYSTEMS WERE DISCARDED BY THE CUSTOMER BUT THE AIMER WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9169067 ↗
• InjuryAug 20, 2019Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE CUSTOMER'S TWO ANTEROMEDIAL FEMORAL AIMERS 5.5MM AND TWO ANTEROMEDIAL FEMORAL AIMERS 6.5MM WERE LEAVING METAL SHAVINGS IN THE PATIENT'S JOINT SPACE. THEY USED A SHAVER TO REMOVE THE METAL SHAVINGS FROM THE PATIENT. THE SALES REP STATED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM BUT THERE WAS A FIFTEEN MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICE ARE OLDER DEVICES AND HAVE SEEN HEAVY USE IN THE FIELD. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8910850 ↗
• InjuryAug 20, 2019Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE CUSTOMER'S TWO ANTEROMEDIAL FEMORAL AIMERS 5.5 MM AND TWO ANTEROMEDIAL FEMORAL AIMERS 6.5 MM WERE LEAVING METAL SHAVINGS IN THE PATIENT'S JOINT SPACE. THEY USED A SHAVER TO REMOVE THE METAL SHAVINGS FROM THE PATIENT. THE SALES REP STATED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM BUT THERE WAS A FIFTEEN MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICE ARE OLDER DEVICES AND HAVE SEEN HEAVY USE IN THE FIELD. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8910809 ↗
• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE TIP OF AIMER WAS OBSERVED BROKEN DURING THE ACL CASE AND WAS NOT USED, ANOTHER AIMER WAS OPENED TO CONTINUE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE DEVICE WAS DISCARDED. 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 7868691 ↗
• MalfunctionAug 27, 2018Break; Crack; Break; Crack

  IT WAS REPORTED THAT ONE (1) 6.5 MM ANTEROMEDIAL FEMORAL AIMER'S TIP BROKE OFF DURING SURGERY. THE BROKEN PIECE DID NOT FALL INTO THE PATIENT. ADDITIONAL AIMER WAS USED TO FINISH PROCEDURE. IT WAS FURTHER REPORTED THAT THE TIP OF THE AIMER CRACKED AND DID NOT SEPARATE FROM THE AIMER. REPORTEDLY, THERE WAS NO PROCEDURAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7820439 ↗
• MalfunctionJun 27, 2017Material Fragmentation; Material Fragmentation

  THE SALES REP REPORTED VIA PHONE THAT THE CUSTOMER'S ANTEROMEDIAL FEMORAL AIMER LEFT METAL SHAVINGS IN THE PATIENT DURING AN ACL PROCEDURE. THE METAL SHAVINGS WERE REMOVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITH THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6672316 ↗