Accord 71360044Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010568205), received between Jun 18, 2020 and May 21, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, THE ACCORD PILOT SCRWDRIVER BIT ((B)(4)) AND THE ACCORD DUAL ENDED HEX DRIVER ((B)(4)) WERE STRIPPED BEFORE THE TORQUE LIMIT DRIVER FUNCTION ENGAGED. IT IS UNKNOWN IF A SIGNIFICANT DELAY HAPPENED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863525 ↗
• MalfunctionApr 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER THR PROCEDURE, THE ACCORD PILOT SCREWDRIVER BIT WAS NOTICED TO BE STRIPPED AND AN OLD STYLE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE AND NO DELAY OR INJURY WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704311 ↗
• MalfunctionJan 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION, ACCORD SCREWDRIVER BIT WITH PILOT TIP AND WAS NOTICED TO BE STRIPPED. BACKUP DEVICE FROM SMITH AND NEPHEW WAS AVAILABLE AND NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT. 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 11109174 ↗
• InjuryDec 5, 2020Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE ACCORD PILOT SCRWDRIVER BIT HAD SOME ISSUES DURING TOTAL HIP REPLACEMENT PROCEDURE THE TIP END OF THE SCREWDRIVER HAS BROKEN. IT CONTINUES TO REMOVE SOME OF THE THREADS FROM THE SCREWS AND WE ARE NOT ABLE TO TIGHTEN IT. THE PROCEDURE WAS FINISHED USING A COMPETITOR DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10951588 ↗
• MalfunctionOct 8, 2020Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation

  IT WAS REPORTED THAT, DURING A ROUTINE EFIP INSPECTION, DEVICE WAS NOTICED TO BE DULL. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10650069 ↗
• MalfunctionJun 24, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT AN ACCORD PILOT SCREWDRIVER BIT IS STRIPPED. NO CASE 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 10192088 ↗
• MalfunctionJun 18, 2020Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THE ACCORD PILOT SCREWDRIVER BIT ARE NOT SEATING PROPERLY, CAUSING SCREWS TO FEEL LIKE THEY ARE STRIPPED DURING TRAUMA FEM. NAILING. INCIDENT OCCURRED DURING SURGERY WITH INSTRUMENTS INSIDE THE 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 10171820 ↗
• MalfunctionJun 18, 2020Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THE ACCORD PILOT SCREWDRIVER BIT ARE NOT SEATING PROPERLY, CAUSING SCREWS TO FEEL LIKE THEY ARE STRIPPED DURING TRAUMA FEM. NAILING. INCIDENT OCCURRED DURING SURGERY WITH INSTRUMENTS INSIDE THE 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 10171818 ↗

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