NA 71364021Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010479112), received between Oct 28, 2020 and Mar 15, 2022 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED THAT THE LOW PROFILE BROACH HANDLE WAS FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776559 ↗
• MalfunctionNov 12, 2021Crack; Crack

  IT WAS REPORTED THAT, WHERE IMPACTING HEAD MEETS THE LOW PROFILE BROACH HANDLE, WELD HAD CRACKED AT SOME POINT. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT. 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 12803631 ↗
• MalfunctionOct 18, 2021Break; Break

  IT WAS REPORTED THAT ONE LOW PROFILE BROACH HANDLE IS BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647774 ↗
• MalfunctionOct 12, 2021Break; Break

  IT WAS REPORTED THAT A LOW PROFILE BROACH HANDLE IS BROKE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615701 ↗
• MalfunctionJun 14, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT TWO (2) LOW PROFILE BROACH HANDLE ARE LOOSE. INCIDENT OCCURRED DURING SET UP OR INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995825 ↗
• MalfunctionJun 14, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT (2) LOW PROFILE BROACH HANDLE ARE LOOSE. INCIDENT OCCURRED DURING SET UP OR INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11991962 ↗
• MalfunctionJun 12, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, 2 LOW PROFILE BROACH HANDLES ARE LOOSE. AS THIS WAS NOTICED DURING INSPECTION ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988796 ↗
• MalfunctionJun 12, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, 2 LOW PROFILE BROACH HANDLES ARE LOOSE. AS THIS WAS NOTICED DURING INSPECTION ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988794 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION A LOW PROFILE BROACH HANDLE WAS FOUND TO BE BROKEN AROUND PINS. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803379 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION A LOW PROFILE BROACH HANDLE WAS FOUND CRACKED AROUND THE PINS. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803254 ↗
• MalfunctionMay 7, 2021Crack; Crack

  IT WAS REPORTED THAT A LOW PROFILE BROACH HANDLE HAS WELDS CRACKED ON IT. AS THIS WAS NOTICED DURING INSPECTION ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794741 ↗
• MalfunctionMay 7, 2021Break; Break

  IT WAS REPORTED THAT A LOW PROFILE BROACH HANDLE HAS THE WELDS BROKEN. AS THIS WAS NOTICED DURING INSPECTION ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794667 ↗
• MalfunctionMay 4, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE LOW PROFILE BROACH HANDLE DOES NOT LOCK PROPERLY ON BROACH. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772827 ↗
• MalfunctionMar 14, 2021Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT, DURING A THR PROCEDURE THE LOW PROFILE BROACH HANDLE WAS NOT ABLE TO LATCH ON TO THE ANTHOLOGY BROACH AND STAY LOCKED. IT WORKED FOR THE FIRST COUPLE BROACHES BUT MUST HAVE BROKEN THROUGH ITS USE. THERE¿S A SMALL CRACK IN THE METAL WHERE THE BROACH MALE END ENGAGES WITH THE FEMALE END OF THE HANDLE. INSTRUMENTS WERE OUTSIDE THE PATIENT. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WAS NO DELAY OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478890 ↗
• MalfunctionFeb 15, 2021Loose or Intermittent Connection; Naturally Worn; Loose or Intermittent Connection; Naturally Worn

  IT WAS REPORTED THAT, DURING A THR WAS NOTICED THE LOW PROFILE BROACH HANDLE IS WORN WHERE THE BROACH LATCHES INTO THE HANDLE. THERE IS MOVEMENT BETWEEN THE BROACH AND HANDLE WHEN CHECKING ROTATIONAL STABILITY DURING THE PROCEDURE. (INSTRUMENTS INSIDE THE PATIENT) THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11326367 ↗
• MalfunctionFeb 15, 2021Loose or Intermittent Connection; Naturally Worn; Loose or Intermittent Connection; Naturally Worn

  IT WAS REPORTED THAT, DURING A THR THE LOW PROFILE BROACH HANDLE IS WORN WHERE THE BROACH LATCHES INTO THE HANDLE. THERE IS MOVEMENT BETWEEN THE BROACH AND HANDLE WHEN CHECKING ROTATIONAL STABILITY DURING THE PROCEDURE. (INSTRUMENTS INSIDE THE PATIENT) THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11326361 ↗
• MalfunctionJan 12, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING INSPECTION, LEVER OF A LOW PROFILE BROACH HANDLE DOES NOT LOCK. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153970 ↗
• MalfunctionNov 11, 2020Break; Break

  IT WAS REPORTED THAT THE LOW PROFILE BROACH HANDLE WAS FOUND TO BE BROKEN. IT IS UNKNOWN WHEN THIS MALFUNCTION OCCURRED AND IF THERE WAS ANY PROCEDURE COMPLICATION. NO INJURIES TO ANY PATIENT. 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 10825425 ↗
• MalfunctionOct 28, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BROACH'S HANDLE WAS LOOSE, WHILE INSIDE THE PATIENT. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10747532 ↗
• MalfunctionOct 28, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BROACH'S HANDLE WAS LOOSE, WHILE INSIDE THE PATIENT. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10747513 ↗

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