SYNERGY 71366709Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010429629), received between Sep 27, 2020 and Oct 19, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2020Nonstandard Device; Dull, Blunt; Material Deformation; Nonstandard Device; Dull, Blunt; Material Deformation

  IT WAS REPORTED THAT, AFTER PROCEDURE, THIS BROACH WAS NOTICED TO BE DULL AND NOT TRUE TO SIZE. THE DEVICE HAD BEEN USED TO COMPLETE THE PROCEDURE AND NO ISSUES WERE REPORTED DURING CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10697006 ↗
• MalfunctionOct 19, 2020Nonstandard Device; Dull, Blunt; Material Deformation; Nonstandard Device; Dull, Blunt; Material Deformation

  IT WAS REPORTED THAT, AFTER PROCEDURE, THIS BROACH WAS NOTICED TO BE DULL AND NOT TRUE TO SIZE. THE DEVICE HAD BEEN USED TO COMPLETE THE PROCEDURE AND NO ISSUES WERE REPORTED DURING CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10697002 ↗
• MalfunctionOct 19, 2020Nonstandard Device; Dull, Blunt; Nonstandard Device; Dull, Blunt

  IT WAS REPORTED THAT, AFTER PROCEDURE, THIS BROACH WAS NOTICED TO BE DULL AND NOT TRUE TO SIZE. THE DEVICE HAD BEEN USED TO COMPLETE THE PROCEDURE AND NO ISSUES WERE REPORTED DURING CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10696997 ↗
• MalfunctionOct 19, 2020Nonstandard Device; Dull, Blunt; Nonstandard Device; Dull, Blunt

  IT WAS REPORTED THAT, AFTER PROCEDURE, THIS BROACH WAS NOTICED TO BE DULL AND NOT TRUE TO SIZE. THE DEVICE HAD BEEN USED TO COMPLETE THE PROCEDURE AND NO ISSUES WERE REPORTED DURING CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10696994 ↗
• MalfunctionOct 19, 2020Nonstandard Device; Dull, Blunt; Nonstandard Device; Dull, Blunt

  IT WAS REPORTED THAT, AFTER PROCEDURE, THIS BROACH WAS NOTICED TO BE DULL AND NOT TRUE TO SIZE. THE DEVICE HAD BEEN USED TO COMPLETE THE PROCEDURE AND NO ISSUES WERE REPORTED DURING CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10696985 ↗
• MalfunctionOct 19, 2020Nonstandard Device; Dull, Blunt; Material Deformation; Nonstandard Device; Dull, Blunt; Material Deformation

  IT WAS REPORTED THAT, AFTER PROCEDURE, THIS BROACH WAS NOTICED TO BE DULL AND NOT TRUE TO SIZE. THE DEVICE HAD BEEN USED TO COMPLETE THE PROCEDURE AND NO ISSUES WERE REPORTED DURING CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10696977 ↗
• 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 10645664 ↗
• MalfunctionSep 27, 2020Fitting Problem; Connection Problem; Incomplete or Inadequate Connection; Fitting Problem; 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10591330 ↗

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