NA 6007-103-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 34546540503221), received between Dec 26, 2018 and Jun 27, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Fracture; Fracture

  PER THE USER FACILITY, DURING A NAVIGATED TOTAL KNEE REPLACEMENT (TKR), 2 TIPS OF THE ORTHOLOCK EX-PINS BROKE OFF DURING REMOVAL. FOLLOWING A RISK ASSESSMENT, A DECISION WAS MADE BY THE SURGEON TO LEAVE THE TIPS IN AS THEY WERE EMBEDDED IN THE PATIENT¿S BONES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22349615 ↗
• InjuryNov 20, 2023Fracture; Fracture

  PER THE CUSTOMER WHEN DOCTOR WENT TO PUT TIBIAL TRACKER FOR A TOTAL KNEE REPLACEMENT SURGERY, THE PIN BROKE AS IT WAS BEING DRILLED INTO THE TIBIA. THE PIN BROKE AT THE BASE OF THE THREADED AREA INSIDE THE PATIENT'S TIBIA. AFTER COMPLETING THE SURGERY, DOCTOR HAD US BRING IN A C-ARM, AND HE WAS ABLE TO GET THE THREADED PORTION OF THE PIN OUT OF THE PATIENT'S TIBIA. THE DOCTOR HAD TO RETRIEVE THE PIN WITH AN EXTRA, SMALL INCISION. HE THEN PACKED THE SMALL HOLE IN THE PATIENT'S TIBIA WITH BONE PUTTY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170478 ↗
• MalfunctionNov 10, 2023Fracture; Fracture

  PER THE CUSTOMER, THE DEVICE TIP FRACTURED DURING A PROCEDURE. PER THE CUSTOMER, THE DEVICE WAS ANGLED TOO MUCH AND THEY DIDN¿T EXPECT THE BONE TO BE SO HARD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18113903 ↗
• MalfunctionAug 31, 2023Fracture; Fracture

  PER THE CUSTOMER, THE TIP OF THE FIXATION PIN FOR ANCHORING THE CLAMP SUPPORT OF NAVIGATION TRACKERS BROKE INTO THE TIBIA OF THE PATIENT UPON REMOVAL WITH THE POWER TOOL. PER THE SURGEON'S DISCRETION, THE TIP WAS LEFT IN THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660544 ↗
• MalfunctionApr 19, 2023Fracture; Fracture

  PER THE CUSTOMER, THE TIP OF THE FIXATION PIN FOR ANCHORING THE CLAMP SUPPORT OF NAVIGATION TRACKERS BROKE INTO THE TIBIA OF THE PATIENT UPON REMOVAL WITH THE POWER TOOL. PER THE SURGEON'S DISCRETION, THE TIP WAS LEFT IN THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Delirium; Pain; Paresis

  MAUDE report 16768130 ↗
• MalfunctionDec 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY A PIN BROKE DURING A CASE. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953164 ↗
• MalfunctionMar 25, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, WHILE INSERTING THE ORTHOLOCK PIN, THE TIP OF THE PIN BROKE OFF IN PATIENTS TIBIA. A SECOND ORTHOLOCK PIN WAS USED TO COMPLETE THE PROCEDURE. THE SURGEON MADE THE DECISION TO LEAVE THE FIRST PIN IN THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570703 ↗
• MalfunctionDec 14, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED, THAT DURING A PROCEDURE AT THE USER FACILITY. WHILE INSERTING, THE ORTHOLOCK EX PIN, THE TIP OF THE PIN BROKE OFF IN PATIENTS BONE. THE SURGEON MADE THE DECISION TO LEAVE THE PIN IN THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002412 ↗
• MalfunctionDec 4, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, WHILE INSERTING THE ORTHOLOCK EX PIN, THE TIP OF THE PIN BROKE OFF IN PATIENTS BONE. THE SURGEON MADE THE DECISION TO LEAVE THE PIN IN THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10945818 ↗
• MalfunctionJul 24, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY AN ORTHOLOCK PIN WAS BROKEN OFF IN THE PATIENT'S BONE DURING A NAVIGATED PROCEDURE. THE PIN WAS INTENTIONALLY LEFT TO PREVENT FURTHER HARM AT THE DISCRETION OF THE SURGEON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10322221 ↗
• MalfunctionNov 25, 2019Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY AN ORTHOLOCK PIN WAS BROKEN OFF IN THE LEFT TIBIAL BONE DURING A NAVIGATED PROCEDURE. THE PIN WAS INTENTIONALLY LEFT TO PREVENT FURTHER HARM AT THE DISCRETION OF THE SURGEON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9373513 ↗
• MalfunctionSep 9, 2019Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ORTHOLOCK EX-PIN'S END BROKE OFF IN THE LEFT TIBIA BONE CANAL. THE SURGEON DECIDED TO NOT REMOVE THE BROKEN TIP AS IT WAS DETERMINED THE REMOVAL CAN INCUR MORE HARM THAN BENEFIT AND THAT THE BROKEN PIN INSIDE THE TIBIA BONE WILL HAVE NO IMPACT TO THE PATIENT'S OUTCOME. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8974792 ↗
• MalfunctionMay 23, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY AN ORTHOLOCK PIN WAS BROKEN OFF IN THE TIBIA OF THE PATIENT. THE PIN WAS INTENTIONALLY LEFT IN THE TIBIA TO PREVENT FURTHER HARM AT THE DISCRETION OF THE SURGEON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8635947 ↗
• MalfunctionDec 26, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY AN ORTHOLOCK PIN WAS BROKEN OFF IN THE KNEE OF THE PATIENT. THE PIN WAS INTENTIONALLY LEFT IN THE KNEE TO PREVENT FURTHER HARM AT THE DISCRETION OF THE SURGEON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196332 ↗