Accord 71360020Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 03596010485359), received between Aug 6, 2018 and Jan 30, 2026 — classified as 11 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY ONE (1) ACCORD TENSIONER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220149 ↗
• MalfunctionJan 28, 2026Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, IT WAS OBSERVED THAT THE TIP OF ONE (1) ACCORD TENSIONER WAS CHIPPED. NO PIECES FELL INSIDE THE PATIENT'S INCISION. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. THE CURRENT HEALTH STATUS OF THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206621 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) ACCORD TENSIONER BROKE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192248 ↗
• MalfunctionAug 15, 2024Separation Failure; Mechanical Jam; Separation Failure; Mechanical Jam

  IT WAS REPORTED THAT, DURING A REVISION INTERNAL FIXATION SURGERY, TWO (2) ACCORD TENSIONER WERE USED BUT THEN THE LOCKING HANDLE BECAME LOCKED AND NOT ABLE TO UNLOCK. MULTIPLE PEOPLE TRIED OF VARIOUS SIZE AND BUILD BUT NO-ONE COULD UNLOCK IT. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, CHANGING THE SURGICAL TECHNIQUE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991310 ↗
• MalfunctionNov 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, ONE (1) ACCORD TENSIONER WAS NOTICED TO BE FRACTURED. ALL THE PIECES WERE REMOVED USING TWEEZERS. THERE ARE NO OPERATIVE REPORTS OR X RAYS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171271 ↗
• MalfunctionOct 4, 2022Break; Mechanics Altered; Break; Mechanics Altered

  IT WAS REPORTED THAT DURING SURGERY, THE CLAMP OF THE ACCORD TENSIONER WOULD TIGHTEN. THE PIECE IS BROKEN. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535446 ↗
• InjuryApr 9, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING THR REVISION, THE ACCORD TENSIONER WAS GETTING STUCK AND NOT RESETTING. PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068769 ↗
• MalfunctionJun 22, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT AN ACCORD TENSIONER DID NOT TENSION CABLE TIGHT ENOUGH. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038842 ↗
• MalfunctionJun 17, 2021Failure to Reset; Failure to Reset

  IT WAS REPORTED THAT AN ACCORD TENSIONER RESET SWITCH DOES NOT WORK CONSISTENTLY. 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 12018352 ↗
• MalfunctionJun 4, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE ACCORD TENSIONER WAS NOT FEEDING THE CABLE THROUGH PROPERLY. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943746 ↗
• MalfunctionJun 1, 2021Break; Break

  IT WAS REPORTED THAT ONE OF THE METAL PIECES ON THE HANDLE OF AN ACCORD TENSIONER BROKE OFF AND WAS FULLY RECOVERED. IT IS UNKNOWN IF THIS HAPPENED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT IS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916522 ↗
• MalfunctionMay 31, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING SURGERY, AN ACCORD TENSIONER HAD A WIRE STUCK IN IT. DEVICE OUTSIDE THE PATIENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AND IF THERE WAS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909296 ↗
• MalfunctionMay 28, 2021Device Damaged by Another Device; Mechanical Jam; Device Damaged by Another Device; Mechanical Jam

  IT WAS REPORTED THAT, DURING THR SURGERY, AN ACCORD TENSIONER WAS UNABLE TO BE USED AS INTENDED BECAUSE A WIRE WAS STUCK IN IT. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED, AS A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE. NEITHER PATIENT INJURY NOR 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 11903087 ↗
• MalfunctionMay 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE ACCORD TENSIONER DID NOT RETRACT ((B)(4)) AND THE ACCORD DUAL ENDED HEX DRIVER WAS STRIPPED ((B)(4)). THERE WERE NO DELAYS AND THE PROCEDURE WAS FINISHED WITH SMITH AND NEPHEW BACK UP DEVICES. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853598 ↗
• MalfunctionMay 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY THE ACCORD TENSIONER CABLE DID NOT TIGHTEN WHEN THE SLACK WAS PULLED OUT. THERE WERE NO BROKEN PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846687 ↗
• MalfunctionMay 17, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT DURING THR SURGERY, ONE ACCORD TENSIONER WAS SLIPPING THE OTHER ACCORD TENSIONER WOULD NOT TENSION ABOVE 50. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832488 ↗
• MalfunctionMay 17, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT DURING THR SURGERY, ONE ACCORD TENSIONER WAS SLIPPING THE OTHER ACCORD TENSIONER WOULD NOT TENSION ABOVE 50. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832475 ↗
• MalfunctionMay 11, 2021Break; Break

  IT WAS REPORTED THAT A ACCORD TENSIONER WAS BROKEN. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT IS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806040 ↗
• MalfunctionMay 7, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ACCORD TENSIONER GOT STUCK. AS THIS WAS DISCOVERED DURING INSPECTION ON THE WAREHOUSE, NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794721 ↗
• MalfunctionMay 5, 2021Break; Break

  IT WAS REPORTED THAT AN ACCORD TENSIONER BROKE. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781283 ↗
• InjuryApr 26, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY AFTER FASTENING IT TO THE FEMUR WITH A PASSER WITH AN ACCORD TENSIONER, THE LOCKING HANDLE DID NOT MOVE WHEN THE FIRST TENSIONER WAS USED TO TIGHTEN IT UP. WHEN THE SECOND TENSIONER WAS USED TO TIGHTEN UP THE LOCKING HANDLE STOP MOVING. THE PROCEDURE WAS COMPLETED WITH 1 HOUR DELAY USING A COMPETITOR BACK-UP DEVICE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722534 ↗
• InjuryApr 26, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY AFTER FASTENING IT TO THE FEMUR WITH A PASSER WITH AN ACCORD TENSIONER, THE LOCKING HANDLE DID NOT MOVE WHEN THE FIRST TENSIONER WAS USED TO TIGHTEN IT UP. WHEN THE SECOND TENSIONER WAS USED TO TIGHTEN UP THE LOCKING HANDLE STOP MOVING. THE PROCEDURE WAS COMPLETED WITH 1 HOUR DELAY USING A COMPETITOR BACK-UP DEVICE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722533 ↗
• InjuryApr 23, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, BOTH TENSIONERS IN THE SET WEREN'T TIGHTEN CORRECTLY AND NEITHER WOULD FEED THE CABLE CORRECTLY. NEED TO BE REPLACED. IT IS UNKNOWN IF THERE WAS A DELAY. PROCEDURE WAS COMPLETED WITHOUT A CABLE. INSTRUMENTS WERE OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720927 ↗
• InjuryApr 23, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, BOTH TENSIONERS IN THE SET WEREN'T TIGHTEN CORRECTLY AND NEITHER WOULD FEED THE CABLE CORRECTLY. NEED TO BE REPLACED. IT IS UNKNOWN IF THERE WAS A DELAY. PROCEDURE WAS COMPLETED WITHOUT A CABLE. INSTRUMENTS WERE OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720917 ↗
• MalfunctionApr 21, 2021Thickening of Material; Thickening of Material

  IT WAS REPORTED THAT DURING AN INSPECTION, IT WAS NOTICED THAT AN ACCORD TENSIONER HAD WEAR AND TEAR PROVOKED BY USE AND IT WAS STARTING TO STICK. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704305 ↗

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