R3 71364477Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 03596010599452), received between Jun 19, 2020 and Jul 16, 2026 — classified as 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (29 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); they may or may not involve this specific model.

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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25842300 ↗
• MalfunctionMar 30, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THR SURGERY, THE SPRING OF A R3 VARIABLE ANGLE DRILL GUIDE BROKE UPON USAGE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722859 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR, THE PIN OF ONE (1) R3 VARIABLE ANGLE DRILL GUIDE FELL OUT DURING STANDARD USAGE. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663173 ↗
• MalfunctionJan 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE DISTAL TIP OF ONE (1) R3 VARIABLE ANGLE DRILL GUIDE BROKE, NOT KEEPING THE GUIDE IN A FIXED POSITION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18511191 ↗
• MalfunctionSep 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING PRODUCT MAINTENANCE, THE END OF AN R3 VARIABLE ANGLE DRILL GUIDE BROKE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342132 ↗
• MalfunctionJul 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SET UP FOR THR, THE TIP OF THE R3 VARIABLE ANGLE DRILL GUIDE BROKE. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951686 ↗
• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED THAT THE PIN HOLDING THE PIECE THAT UNLOCKS HEAD OF A R3 VARIABLE ANGLE DRILL GUIDE HAD BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14003842 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT, AN R3 VARIABLE ANGLE DRILL GUIDE BROKE. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13975684 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED THAT, DURING THR, THE R3 VARIABLE ANGLE DRILL GUIDE LOCKING TIP BROKE, OUTSIDE OF THE PATIENT. PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, BY USING A DEVICE FROM ANOTHER TRAY. NO OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625969 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE ORANGE RING OF AN R3 VARIABLE ANGLE DRILL GUIDE BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195354 ↗
• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR, A R3 VARIABLE ANGLE DRILL GUIDE BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, WITHOUT THE INSTRUMENT. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13097601 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE END OF AN R3 VARIABLE ANGLE DRILL GUIDE WAS JAMMED. THE SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. THE PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. THE INVESTIGATION FOUND THAT THE TIP OF THE DEVICE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759120 ↗
• MalfunctionOct 15, 2021Break; Break

  IT WAS REPORTED THAT, R3 VARIABLE ANGLE DRILL GUIDE WAS BROKEN. 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 12643339 ↗
• MalfunctionOct 7, 2021Break; Break

  IT WAS REPORTED THAT, R3 VARIABLE ANGLE DRILL GUIDE WAS BROKEN. 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 12595078 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A THR SURGERY, ONE R3 VARIABLE ANGLE DRILL GUIDE WAS FOUND TO HAVE THE TIP BROKEN. THIS HAPPENED AFTER USE IN PATIENT. SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577485 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT A R3 VARIABLE ANGLE DRILL GUIDE BROKE WHILE BEING WASHED. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576565 ↗
• MalfunctionOct 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A THR SURGERY, IT WAS NOTICED THAT THE ORANGE PART OF A R3 VARIABLE ANGLE DRILL GUIDE WAS BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. NO ITEM FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565432 ↗
• MalfunctionSep 30, 2021Break; Break

  IT WAS REPORTED THAT, A R3 VARIABLE ANGLE DRILL GUIDE WAS FOUND BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558533 ↗
• MalfunctionSep 27, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A THR SURGERY, AN R3 VARIABLE ANGLE DRILL GUIDE WAS NOTICED TO BE BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538207 ↗
• MalfunctionSep 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE R3 VARIABLE ANGLE DRILL GUIDE BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532392 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THAT A R3 VARIABLE ANGLE DRILL GUIDE IS BROKE. IT IS UNKNOWN IF THIS HAPPENED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236153 ↗
• MalfunctionJul 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR A THR, IT WAS FOUND THAT A R3 VARIABLE ANGLE DRILL GUIDE WAS BROKEN. SURGERY WAS FINISHED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171153 ↗
• MalfunctionJul 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A R3 VARIABLE ANGLE DRILL GUIDE BROKE WHILE WAS USED. DEVICE OUTSIDE 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 12171108 ↗
• MalfunctionJun 30, 2021Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT, AFTER A THR SURGERY, AN R3 VARIABLE ANGLE DRILL GUIDE BROKE AND THE PIN THAT RETRACTS THE ADJUSTABILITY OF THE GUIDE WAS MISSING. SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE BUT A SMITH & NEPHEW BACKUP DEVICE WAS AVAILABLE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097498 ↗
• MalfunctionJun 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A R3 VARIABLE ANGLE DRILL GUIDE LOST ITS RETENTION PIN CASE (B)(4), AND THAT A R3 DEPTH GAUGE BROKE CASE (B)(4). AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038843 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116