SL-PLUS/SBG/IPA 75007308Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07611996074895), received between Aug 11, 2020 and Apr 17, 2024 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2024Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124876 ↗
• MalfunctionNov 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE END OF A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM BROKE OFF WHILE THE SURGEON WAS BROACHING THE FEMUR. NO PARTS FELL INTO THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18119958 ↗
• InjuryApr 12, 2023Break; Break

  IT WAS REPORTED THAT DURING THR SURGERY, A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM BROKE. THE BOLT FELL INSIDE THE PATIENT'S ANATOMY AND WAS RETRIEVED BY THE SURGEON. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728318 ↗
• MalfunctionSep 15, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM CONNECTION MECHANISM IS BROKEN. SINCE IT WAS NOTICED DURING AN INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434218 ↗
• MalfunctionJul 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THR, THE HANDLE OF THE SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM BROKE, NO PIECES FELL INTO THE PATIENT AS THE BROKEN PART REMAINED IN THE BROACH HANDLE. THE SURGEON INSPECTED THE BREAK BY ASSEMBLING THE 2 PARTS BY HAND ON THE BACK TABLE, TO ASSURE NO ¿CHIPS¿ WERE UNACCOUNTED FOR. 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 14974401 ↗
• MalfunctionMay 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A 40MM OFFSET ADAPTER BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492566 ↗
• MalfunctionSep 30, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A SL-PLUS MIA OFFSET ADAPTER 40MM SET BROKE. SURGERY WAS RESUMED WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND WHEN OCCURRED. NEVERTHELESS, PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558700 ↗
• InjurySep 6, 2021Break; Break

  IT WAS REPORTED THAT DURING A THR THE HANDLE OF A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM BROKE. PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACKUP DEVICE, NO DELAY REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431066 ↗
• MalfunctionAug 26, 2021Break; Break

  IT WAS REPORTED THAT A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40 MM IS BROKEN. IT IS UNKNOWN IN WHAT CONTEXT THIS FAILURE WAS OBSERVED, OR IF THERE WAS PATIENT INVOLVEMENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375421 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A THR SURGERY, A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40 MM BROKE. SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH THIS DEVICE. AS THIS HAPPENED AFTER THE PROCEDURE, THE PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239460 ↗
• InjuryJan 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT AN ATTACHMENT OF THE PLUS SL-PLUS MIA DBL OFFSET ADAPT. HAS BROKEN OFF IN LARGE KNOCK PLATE WHILE BROACH WAS IMPACTED INTO PATIENT. PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11183308 ↗
• MalfunctionNov 17, 2020Corroded; Corroded

  IT WAS REPORTED THAT SOME RUST HAS STARTING TO FORM IN THE SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM. NO PROCEDURE RELATED.

  Patient problems: No Patient Involvement

  MAUDE report 10857342 ↗
• MalfunctionNov 17, 2020Corroded; Corroded

  IT WAS REPORTED THAT SOME RUST HAS STARTING TO FORM IN THE SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM. NO PROCEDURE RELATED.

  Patient problems: No Patient Involvement

  MAUDE report 10857340 ↗
• MalfunctionAug 11, 2020Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED TAT THE TIP OF THE SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM THAT CONNECTS ONTO BROACH HANDLE PLATE BROKE OFF WHILE IMPACTING. ITEM BROKE OUTSIDE THE PATIENT. NO INJURIES OR SURGICAL DELAYS REPORTED. PROCEDURE WAS FINISHED WITH AN S+N BACKUP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394243 ↗

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