SPECIALIST 96-6510Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295248620), received between Aug 21, 2018 and Sep 17, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Break; Break

  DURING THE PROCEDURE, THE HANDLE BROKE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236368 ↗
• MalfunctionApr 12, 2024Break; Break

  IT WAS REPORTED THAT THE BACK OF THE BLACK SLAP BROKE OFF. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19095376 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT THE END CAP OF THE SLAP HAMMER ATTACHMENT BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080946 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT DURING TOTAL KNEE REPLACEMENT, WHEN THE SURGEON WAS POSITIONING THE TEST, THIS PIECE BROKE IN THE PROXIMAL HANDLE, LEAVING TWO BROKEN PIECES. IT ENDS CX WITHOUT AFFECTING THE PATIENT. ANOTHER PIECE OF THE UNCOMPLICATED MATERIAL IS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596830 ↗
• MalfunctionJun 12, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE FEMUR INSERT/EXTRACTOR HANDLE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107863 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT THE FEMUR INSERT/EXTRACTOR HANDLE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 17107662 ↗
• MalfunctionMay 1, 2023Break; Break

  IT WAS REPORTED THAT THE ITEM IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844750 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT THE STOPPER AT TOP OF SLAP HANDLE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245864 ↗
• MalfunctionNov 21, 2022Break; Break

  IT WAS REPORTED THAT THE SLAP HAMMER BROKE UP THE PIN EXTRACTION OF THE FEMORAL TRIAL. THERE WAS NO REPORTED SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835504 ↗
• MalfunctionAug 16, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED INSTRUMENT IS WORN DUE TO GENERAL WEAR AND TEAR AND AN ATTACHMENT IS BROKEN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232178 ↗
• MalfunctionAug 3, 2022Break; Break

  IT WAS REPORTED THAT THE SLAP HAMMER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15158029 ↗
• MalfunctionApr 29, 2022Break; Break

  THE TOP OF THE SLAM HAMMER BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250393 ↗
• MalfunctionDec 14, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT INSTRUMENT BROKE INTO TWO PIECES AND THERE WAS ABOUT A 5 MIN SURGICAL DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001122 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT WHEN USED TO IMPACT THE DEFINITIVE KNEE PROSTHESIS, THE BACK OF THE IMPACTOR STOP WAS BROKEN BY HAMMER BLOWS. IT DID NOT AFFECT THE PATIENT BECAUSE IT WAS RESOLVED WITH ANOTHER IMPACTOR THAT WAS IN THE EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802738 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN AND NO LONGER USABLE. THE SLAP HAMMER WAS USED DURING SURGERY AND FOUND TO BE BROKEN AND NOT USABLE. THERE WAS NO IMPACT ON SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235162 ↗
• MalfunctionJun 14, 2021Break; Break

  IT WAS REPORTED THAT THE EXTRACTOR BASE BROKE OFF WHILE MALLETING ON FEMORAL TRIAL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992202 ↗
• MalfunctionSep 18, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE HCP PROVIDED THE SALES REP WITH WRONG COMPLAINT INFO MISTAKENLY. THE CORRECT COMPLAINT INFO IS THAT THE THREAD OF SP2 SLAP HAMMER ATTACHMENT DOES NOT GRIP IN THE PAN AND COULD NOT BE USED ANYMORE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10556319 ↗
• MalfunctionJul 30, 2019Break; Break

  IT WAS REPORTED PROXIMAL OF THE INSTRUMENT PART BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8840847 ↗
• MalfunctionAug 21, 2018Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BELOW WAS FOUND TO BE DAMAGED UPON INSPECTION AFTER THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7802682 ↗