JOURNEY 74016421Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885556692233), received between Jul 7, 2020 and Jun 17, 2026 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A UKR SURGERY, ONE (1) FEMORAL PEG DRILL WAS NOTED THAT METAL SHARDS HAD COME AWAY FROM THE FRILL AS IT WAS USED IN THE DRILL HOLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. ALL OF THE METAL SHARDS WERE REMOVED AND ACCOUNTED. FORCEPS WERE USED TO RETRIEVE THE METAL SHARDS FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537489 ↗
• MalfunctionMay 9, 2025Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT, DURING TKA, ONE (1) FEMORAL PEG DRILL HAD DEEP GROOVES ON THE SHAFT AND CREATED METAL DEBRIS, INSIDE THE PATIENT. MATERIAL WAS REMOVED BY IRRIGATION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993525 ↗
• MalfunctionJan 10, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) FEMORAL PEG DRILL IS BINDING TO ONE (1) JRNY II UNI RESECT AP BLOCK RM/LL SZ 8. THE PROCEDURE WAS PERFORMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134843 ↗
• MalfunctionDec 19, 2022Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE FEMORAL PEG DRILL DEVICE GOT BOUND UP IN THE POSTERIOR DRILL HOLE. METAL SHAVINGS WERE NOTICED AND WERE REMOVED FROM THE CUTTING BLOCK WITH SUCTION, NO SHAVINGS WERE INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009515 ↗
• InjuryOct 12, 2022Material Fragmentation; Difficult to Insert; Material Split, Cut or Torn; Material Fragmentation; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY SURGERY, WHILE USING A FEMORAL PEG DRILL ALONG WITH A JRNY II UNI RESECT AP BLOCK LM/RL SZ 3, A LARGE AMOUNT OF METAL LINTS WERE GENERATED. THE METAL LINTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, BY CONDUCTING THE PEG DRILLING BY FREEHAND. PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591246 ↗
• MalfunctionAug 17, 2022Material Fragmentation; Thickening of Material; Material Fragmentation; Thickening of Material

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE SURGEON WAS DRILLING FOR THE FEMORAL LUGS, THE FEMORAL PEG DRILL WAS DULL AND DID NOT CORRECTLY LINING UP WITH THE LUG HOLES.IT WAS NOTICED SOME METAL DEBRIS FROM THE DRILL. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245853 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT, A FEMORAL PEG DRILL WAS BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13722737 ↗
• MalfunctionJan 3, 2022Material Fragmentation; Physical Resistance/Sticking; Material Fragmentation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE FEMORAL PEG DRILL CONTINUES TO BIND IN THE POSTERIOR LUG HOLE OF THE 2-IN-1 CUT BLOCKS. SIGNIFICANT METAL DEBRIS CAUSED BY THE BINDING. LUG DRILL ULTIMATELY LOCKED ITSELF IN THE LUG HOLE, NEEDING SIGNIFICANT FORCE TO DISASSOCIATE, CAUSING CUT BLOCK TO SHIFT BEFORE MAKING SAW CUTS. IT IS OUR UNDERSTANDING THERE NOW EXIST A NEW LUG DRILL TO AVOID THIS ISSUE. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13146228 ↗
• InjuryNov 16, 2021Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, WHILE DRILLING OF POSTERIOR LUG HOLE, A FEMORAL PEG DRILL BOUND IN A JOURNEY II CUTTING BLOCK AND SHED METAL SHAVINGS INSIDE THE PATIENT. THE CUTTING BLOCK WAS DAMAGED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820502 ↗
• MalfunctionAug 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, A FEMORAL PEG DRILL BINDS IN THE CUTTING BLOCK. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285573 ↗
• InjuryMar 10, 2021Material Fragmentation; Connection Problem; Material Fragmentation; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY THE FEMORAL PEG DRILL WAS NOT FITTING PROPERLY INSIDE THE POSTERIOR LUG HOLE OF THE JUK AP FEMORAL CUTTING BLOCK. THE DRILL WAS SCRATCHING AGAINST THE BLOCK AND LEAVING METAL DEBRIS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A LESS THAN OR EQUAL TO 30 MINS DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11449968 ↗
• InjuryNov 2, 2020Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON HAD DIFFICULTIES TO USE THE FEMORAL PEG DRILL TO DRILL POSTERIOR HOLES THROUGH THE JUK AP FEMORAL BLOCKS. METAL SHAVINGS WERE OBSERVED BY THE SURGEON & LAVAGE SUCTIONED FROM THE SURGICAL SITE. SURGEON HAD TO REDRILL THE POSTERIOR HOLE. NO FURTHER ISSUES ARE REPORTED AND THE DELAY WAS A MINUTE OR TWO TO REDRILL THE HOLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10775375 ↗
• MalfunctionOct 2, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED AN INCREASED RESISTANCE WHILE DRILLING WITH THE FEMORAL PEG DRILL DURING A TKA SURGERY, ALSO WEAR PATTERNS APPEAR TO BE FORMING ON THE SHAFTS OF THE DRILL BIT; THERE IS NO INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED NOR IF THERE WAS ANY DELAY. NO OTHER PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10620789 ↗
• MalfunctionOct 2, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED AN INCREASED RESISTANCE WHILE DRILLING WITH THE FEMORAL PEG DRILL DURING A TKA SURGERY, ALSO WEAR PATTERNS APPEAR TO BE FORMING ON THE SHAFTS OF THE DRILL BIT; THERE IS NO INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED NOR IF THERE WAS ANY DELAY. NO OTHER PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10620760 ↗
• MalfunctionOct 2, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED AN INCREASED RESISTANCE WHILE DRILLING WITH THE FEMORAL PEG DRILL DURING A TKA SURGERY, ALSO WEAR PATTERNS APPEAR TO BE FORMING ON THE SHAFTS OF THE DRILL BIT; THERE IS NO INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED NOR IF THERE WAS ANY DELAY. NO OTHER PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10620757 ↗
• MalfunctionOct 2, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED AN INCREASED RESISTANCE WHILE DRILLING WITH THE FEMORAL PEG DRILL DURING A TKA SURGERY, ALSO WEAR PATTERNS APPEAR TO BE FORMING ON THE SHAFTS OF THE DRILL BIT; THERE IS NO INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED NOR IF THERE WAS ANY DELAY. NO OTHER PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10620743 ↗
• InjuryJul 7, 2020Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT THE UK 2 UNI FEMORAL PEG DRILL BOUND IN THE CUTTING BLOCK AND CAUSED METAL DEBRIS IN THE WOUND. THE EVENT OCCURRED DURING SURGERY, WITH INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE AND A DELAY OF 30 MIN OR LESS WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10240813 ↗