Anthology 71365208Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010559753), received between Mar 20, 2020 and Mar 3, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE ANTHOLOGY ANTERIOR BROACH SZ 8 EDGE MARKER SHEARED OFF IN CASE. INCIDENT OCCURRED WITH INSTRUMENT INSIDE PATIENT. ALL PIECES WERE ACCOUNTED FOR. SURGERY WAS RESUMED, WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. PATIENT WAS NOT HARMED BEYOND THE REPORTED ISSUE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664266 ↗
• MalfunctionFeb 8, 2022Break; Break

  IT WAS REPORTED THAT ANTHOLOGY ANTERIOR BROACH SZ 8 BROKE DURING CLEANING. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478776 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT, THE METAL ON TOP OF A ANTHOLOGY ANTERIOR BROACH SZ 8 APPEARS TO BE CHIPPED OFF WHERE THE "8" IS. 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 12656866 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A THR PROCEDURE, THE TOP OF THE ANTHOLOGY ANTERIOR BROACH SIZE 8 BROKE WITH USE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593392 ↗
• MalfunctionMar 20, 2020Break; Break

  IT WAS REPORTED THAT DURING A THR PROCEDURE, PERFORMING THE FEMORAL PREP THE #8 ANTHOLOGY BROACH BROKE AT THE PROXIMAL END, WHICH DID NOT ALLOW THE NECK ANGLE TO SEAT ON THE BROACH PRIOR TO TRIALING. ALL PIECES WERE RECOVERED. LENGTH OF DELAY IS UNKNOWN. SMITH & NEPHEW BACKUP DEVICE WAS AVAILABLE. NO IMPACT OR INJURY TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9860672 ↗

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