Accord 71360046Recalls & reported problems

Summary

The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 03596010611543), received between May 14, 2018 and Aug 9, 2024 — classified as 13 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (74 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 25 most recent of 171 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING SURGERY, THE ACCORD DUAL ENDED HEX DRIVER WAS UNABLE TO TIGHTEN THE ACC 2.0MM COCR CABLE W/CLAMP. SURGERY WAS PERFORMED, WITH A GREATER THAN 30 MINUTES DELAY, WITH BOTH SCREW DRIVER AND CABLE FROM COMPETITOR'S DEVICE. PATIENT IS IN GOOD HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950867 ↗
• MalfunctionMay 24, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING A REVISION SURGERY, THE SURGEON WAS USING AN ACCORD CABLING SET. THE SURGEON ASKED FOR 2 CABLES TO BE OPENED, IMMEDIATELY FOLLOWING THE REMOVAL OF THE FEMORAL STEM. ONCE ADEQUATE TENSION WAS ACHIEVED, THE CABLES NEEDED TO BE LOCKED OFF BY TIGHTENING A SCREW USING A TORQUE LIMITING DRIVER. THE NURSE WAS INSTRUCTED TO PUT THE ACCORD DUAL ENDED HEX DRIVER ON THE TORQUE DRIVER HANDLE. SURGEON TRIED TIGHTENING THE SCREW UNTIL THE AUDIBLE CLICK OF THE TORQUE LIMITING DRIVER, HOWEVER, THE ACCORD DUAL ENDED HEX DRIVER TIP WAS SO BADLY STRIPPED THAT HE WAS NOT ABLE TO TIGHTEN THE SCREW TO LOCK THE TENSION OF THE CABLE. THE SET USUALLY CONTAINS TWO (2) DRIVERS, BOTH OF WHICH WERE NOT USABLE. AS A RESULT, HE WAS UNABLE TO USE THE CABLES AND SURGERY WAS COMPLETED, AFTER A SIGNIFICANT DELAY, USING A COMPETITOR DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993427 ↗
• MalfunctionFeb 8, 2022Break; Break

  IT WAS REPORTED THAT AN ACCORD DUAL ENDED HEX DRIVER BROKE. SINCE IT WAS NOTICED DURING AN INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13486917 ↗
• MalfunctionNov 24, 2021Break; Break

  IT WAS REPORTED THAT, FROM THE LISTED DEVICES, FOUR (4) HAD A FAULTY JOINT AND THE OTHER ONES WERE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868986 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT A ACCORD DUAL ENDED HEX DRIVER IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866445 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT A ACCORD DUAL ENDED HEX DRIVER IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866381 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT A ACCORD DUAL ENDED HEX DRIVER IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866379 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND/OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860812 ↗
• MalfunctionSep 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF TWO (2) ACCORD DUAL ENDED HEX DRIVERS ARE STRIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537231 ↗
• MalfunctionSep 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF (2) ACCORD DUAL ENDED HEX DRIVERS ARE STRIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12534024 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497168 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497108 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497099 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497074 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497051 ↗
• MalfunctionSep 20, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497018 ↗
• MalfunctionSep 20, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496960 ↗
• MalfunctionJun 22, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN ACCORD DUAL ENDED HEX DRIVER WAS STRIPPED ON ONE SIDE OF THE HEX. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12043038 ↗
• MalfunctionJun 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN INSPECTION, IT WAS NOTICED THAT THE TIP OF A ACCORD DUAL ENDED HEX DRIVER WAS ROUNDING OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943721 ↗
• MalfunctionJun 2, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE ENDS OF A ACCORD DUAL ENDED HEX DRIVER WERE WORN DOWN AND STRIPPED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921516 ↗
• MalfunctionMay 31, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A THR, THE ACCORD DUAL ENDED HEX DRIVER WAS STRIPPED FROM NORMAL USE. THERE WAS A DELAY OF 30 MINUTES OR LESS AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909315 ↗
• MalfunctionMay 31, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SURGERY, AN ACCORD DUAL ENDED HEX DRIVER WAS STRIPPED. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909305 ↗
• MalfunctionMay 31, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A THR, THE ACCORD DUAL ENDED HEX DRIVER WAS STRIPPED FROM NORMAL USE. THERE WAS A DELAY OF 30 MINUTES OR LESS AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909290 ↗
• MalfunctionMay 28, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING INSPECTION, THE THREADS ON AN ACCORD DUAL ENDED HEX DRIVER WERE NOTICED TO BE STRIPPED. NO CASE INVOLVED; THEREFORE, NO PATIENT WAS 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

  MAUDE report 11904499 ↗
• MalfunctionMay 28, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING THR SURGERY, AN ACCORD DUAL ENDED HEX DRIVER WAS NOTICED TO BE STRIPPED. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE TO CONCLUDE THE PROCEDURE. 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 11903077 ↗

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