NA 254687Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705013685), received between Oct 30, 2018 and Jun 9, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Break; Break

  REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE RIGIDLOOP PASSING PIN 2.4MM DEVICE PRODUCED A LOT OF METAL DEBRIS WHEN IT WAS DRILLING THROUGH THE FEMORAL OFFSET AIMER ANTEROMEDIAL FEMORAL AIMER 7.5MM -NS DEVICE. ANOTHER RIGIDLOOP PASSING PIN 2.4MM DEVICE WAS USED BUT THE SAME ISSUE OCCURRED. 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 22165590 ↗
• MalfunctionNov 11, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE USING AN ANTEROMEDIAL FEMORAL AIMER 7.5MM DEVICE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE USED BECAUSE WHEN INSERTING THE INITIATING PIN TO CREATE A CHANNEL IN THE FEMORAL BONE, THE PIN BECAME STUCK IN THE GUIDE. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE OR IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652045 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN AUSTRALIA 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 7.5MM 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 13624657 ↗
• MalfunctionMar 15, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANTEROMEDIAL FEMORAL AIMER 7.5MM DEVICE WAS LOOSE. ANOTHER LIKE DEVICE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486520 ↗
• MalfunctionJul 24, 2020Corroded; Degraded; Corroded; Degraded

  THIS IS REPORT 3 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 10319587 ↗
• MalfunctionSep 27, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY THE SALES REP THAT THE ANTEROMEDIAL FEMORAL AIMER 7.5MM DEVICE WAS LOOSE WHERE THE HANDLE AND DRIVER MEET. THE SALES REP STATED THAT THE CUSTOMER DID NOT REPORT ANY PATIENT HARMS TO HIM. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 9130238 ↗
• MalfunctionOct 30, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT WHILE CHECKING HIS INVENTORY, THE SALES REP'S ANTEROMEDIAL FEMORAL AIMER 7.5MM HAS IMPERFECTIONS AROUND THE EXIT POINT. THE SALES REP STATED THE WIRE DOES NOT PASS THROUGH EASILY AND CAN CREATE METAL SHAVINGS. THE ISSUE WAS FOUND UNRELATED TO A CASE, AND THEREFORE THERE WAS NO PATIENT INVOLVEMENT AND NO DELAYS. THE DEVICE IS BEING RETURNED FOR EVALUATION. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 8019933 ↗