R3 71366428Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010656056), received between Aug 1, 2020 and Oct 12, 2022 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT, TWO R3 LNR MPACTOR HD II 28MM WERE FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592079 ↗
• MalfunctionOct 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING INSPECTION, TWO (2) R3 LNR MPACTOR HD II 28MM WERE FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591369 ↗
• MalfunctionJun 6, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A R3 LNR IMPACTOR HD II 28MM BROKE DURING SURGERY. NO PIECES FELL INTO PATIENT. 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 14611110 ↗
• InjuryJun 18, 2021Crack; Crack

  IT WAS REPORTED THAT AN R3 LINER IMPACTOR HEAD CRACKED WHILE BEING IMPACTED DURING A TOTAL HIP ARTHROPLASTY. THE PROCEDURE WAS COMPLETED WITH THE SAME SURGICAL TECHNIQUE USING AN SMITH & NEPHEW BACK UP DEVICE AND WITHOUT DELAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022918 ↗
• MalfunctionJan 28, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP THE ITEM WAS FOUND TO BE BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11248069 ↗
• InjuryJan 20, 2021Break; Break

  IT WAS REPORTED THAT THE R3 LNR MPACTOR HD II 28MM BROKE DURING A THR PROCEDURE UPON IMPACTION. THERE WAS NO DELAY. PROCEDURE CONCLUDED WITH A S&N BACK UP DEVICE. NO OTHER COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205276 ↗
• InjuryNov 26, 2020Break; Break

  IT WAS REPORTED THAT THE IMPACTOR BROKE DURING OPERATION, INSIDE THE PATIENT. ALL PIECES WERE RECOVERED. SURGICAL DELAY LESS THAN 30 MINUTES. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912573 ↗
• MalfunctionNov 17, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE HEAD OF THE R3 LNR MPACTOR HD II 28MM WAS FOUND BROKEN. NO CASE RELATED, THEREFORE NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10850462 ↗
• InjuryAug 1, 2020Break; Break

  IT WAS REPORTED THAT THE R3 LINER IMPACTOR HD II 28MM CRACKED WHILE BEING IMPACTED IN THE PATIENT. PROCEDURE WAS FINISHED WITH A SN BACKUP DEVICE. ANY OTHER ISSUE THAT COULD AFFECT THE PATIENT'S CONDITION WAS NOT REPORTED BY THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INCONVENIENCES TO THE PATIENT'S CONDITION WERE NOT REPORTED DUE TO THIS EVENT.

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

  MAUDE report 10354125 ↗

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