SYNERGY 71366716Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010429698), received between Sep 6, 2018 and Feb 21, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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.

• MalfunctionFeb 21, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, WHERE THE BROACH ATTACHES TO THE BROACH HANDLE IT BROKE OFF AND THE STAFF WAS UNABLE TO GET THE BROACH TRIAL OUT. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH AN EQUIVALENT S+N BACK-UP PRODUCT. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410360 ↗
• MalfunctionOct 7, 2020Defective Device; Connection Problem; Defective Device; Connection Problem

  IT WAS REPORTED THAT SURGEON DOES NOT LIKE HOW THE BROACHES ARE SEATING. NO CASE RELATED, THEREFORE NO PATIENT INVOLVED. 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; No Patient Involvement

  MAUDE report 10645691 ↗
• MalfunctionSep 27, 2020Connection Problem; Incomplete or Inadequate Connection; Connection Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE BROACHES WERE NOT SEATING PROPERLY. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10591322 ↗
• InjuryOct 21, 2019Break; Break

  IT WAS REPORTED THAT DURING A THR, THE SIZE 16 BROACH CONNECTOR BROKE WHILE THE SURGEON WAS TRYING TO TAKE OUT THE BROACH STEM AFTER TRAILING. THE PIECE THAT CONNECTS TO THE BROACH HANDLE BROKE OFF AND THE BROACH STEM REMAINED IN THE PATIENT¿S FEMUR. THE SURGEON WAS ABLE TO MAKE A SMALL INCISION AND REMOVE THE BROACH STEM WITH A BONE HOOK. THERE WAS A DELAY REPORTED OF 10 MIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9216088 ↗
• InjurySep 6, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS REQUIRED DUE TO 16 BROACH (7136-6716, 14FM18758) SHRED OFF THE BROACH DURING HIP REPLACEMENT WITH HIGH OFFSET TRIAL NECK 7136-6514, 14GM06585. DR PERFORMED OSTEOTOMY TO REMOVE THE BROACH SUCCESSFULLY. THERE WAS 40 MINUTE DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7851908 ↗

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