RENOVATION 71367541Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010402738), received between Jul 7, 2020 and Jul 4, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SMALL SLAP HAMMER THREADING BROKE OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911143 ↗
• MalfunctionMay 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF A SMALL SLAP HAMMER IS MISSING. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455137 ↗
• InjuryDec 17, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT, THE SURGEON WAS UNABLE TO ATTACH THE SLAP HAMMER TO THE IMPACTOR DURING A SURGERY. THE SURGEON WAS ABLE TO USE A MALLET INSTEAD OF THE SLAP HAMMER. A SMITH+NEPHEW ALTERNATE IMPACTOR WAS AVAILABLE. NO HARM DONE TO THE PATIENT AND NO TIME ADDED TO THE CASE. 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 11027331 ↗
• InjuryJul 7, 2020Break; Break

  IT WAS REPORTED THAT A R3 SLAPHAMMER BROKE INTRAOPERATIVE. NO ITEMS WERE LEFT IN PATIENT, NO HARM WAS DONE TO THE PATIENT AND NO DELAY WAS REPORTED. S+N BACKUP WAS AVAILABLE, BUT NOT NEEDED. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10242418 ↗

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