NA 254672Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705013548), received between Jun 6, 2018 and Sep 15, 2024 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information

  THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE ANTEROMEDIAL FEMORAL AIMER, 5.5MM 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 20220928 ↗
• MalfunctionSep 23, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION, TWO ANTEROMEDIAL FEMORAL AIMER 5.5 MM WERE SLIGHTLY BENT WHICH AFFECTED VISUALIZATION OF CALIBRATORS. SURGEON WAS ABLE TO ESTIMATE DEPTH OF TUNNEL WITHOUT THE CALIBRATIONS (AFTER THEY WERE WORN OFF DURING DRILLING) NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10576936 ↗
• MalfunctionSep 23, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION, TWO ANTEROMEDIAL FEMORAL AIMER 5.5 MM WERE SLIGHTLY BENT WHICH AFFECTED VISUALIZATION OF CALIBRATORS. SURGEON WAS ABLE TO ESTIMATE DEPTH OF TUNNEL WITHOUT THE CALIBRATIONS (AFTER THEY WERE WORN OFF DURING DRILLING) NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10576887 ↗
• MalfunctionJul 24, 2020Corroded; Degraded; Corroded; Degraded

  THIS IS REPORT 4 OF 5 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING STERILIZATION PRIOR TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRAFT PREP SYS SLIDERUNIT (2 REQ) EA DEVICE HAD SOME RUST SPOTS PARTICULARLY ON THE WRITINGS (LETTERS). IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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 10319592 ↗
• MalfunctionDec 27, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE HANDLE AND SHAFT OF THE FEMORAL INTRAFIX SYSTEM 8 MM-8.5 MM X 23 MM, HARD IS GETTING LOOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9526231 ↗
• 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 8910706 ↗
• 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 8910649 ↗
• InjuryJun 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE CUSTOMER'S ANTEROMEDIAL FEMORAL AIMER CREATED METAL SHAVINGS IN THE PATIENT'S JOINT SPACE. THE SALES REP COULD NOT CONFIRM IF ALL THE METAL SHAVINGS WERE REMOVED FROM THE JOINT SPACE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH A FIVE MINUTE DELAY TO SWAP OUT THE DEVICE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7574618 ↗