Accord 71340007Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 03596010485731), received between Apr 12, 2017 and Aug 4, 2025 — classified as 29 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (19 reports).

1 other recall cover devices cleared under the same FDA submission (K031162, K211176, K223762, K233949); 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED DISCOMFORT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) ACC 2.0MM COCR CABLE W/CLAMP WAS REMOVED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 22710727 ↗
• MalfunctionSep 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AN ACC 2.0MM COCR CABLE W/CLAMP TORE WHILE TENSIONING. ALL PIECES WERE REMOVED BY HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338562 ↗
• InjuryAug 7, 2024Fracture; Device Slipped; Fracture; Device Slipped

  IT WAS REPORTED THAT, DURING STEM PREPARATION IN A THR SURGERY, A FEMORAL FRACTURE OCCURRED WHILE USING A NON-SMITH AND NEPHEW PETER BREHM STEM, FOLLOWED BY ONE (1) ACC 2.0MM COCR CABLE W/CLAMP SLIPPING OUT OF THE CLAMP DESPITE THE TORQUE LOCK AS A CONSEQUENCE OF THE BONE FRACTURE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING A COMPETITOR¿S SYNTHES CABLE DEVICE. A SAMPLE DEVICE SLIPPED FROM THE BONE INTO THE SOFT TISSUE CAUSING POTENTIAL INJURIES TO MUSCLE AND TO OTHER NON VERIFIABLE AREA SINCE IT WAS OVERLAID. ALSO, ADDITIONAL X-RAYS WERE USED. NO OTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: Bone Fracture(s); Bruise/Contusion; Erosion; Hip Fracture; Insufficient Information

  MAUDE report 19935338 ↗
• MalfunctionJul 5, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT, DURING THE EXCHANGE OF A COMPETITOR'S THR PRIMARY SYSTEM TO A REDAPT SYSTEM, AT THE MOMENT TENSIONING TWO (2) ACCORD 2.0MM COBALT CHROME CABLES, THE FIBERS BEGAN TO UNRAVEL. IT IS UNKNOWN IF THIS FAILURE REQUIRED FURTHER INTERVENTION. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680227 ↗
• MalfunctionNov 30, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE TIGHTENING, THE CLAMP OF AN ACC 2.0MM COCR CABLE W/CLAMP BROKE. NO PIECES FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237578 ↗
• InjuryMar 2, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE CABLE OF AN ACCORD 2.0MM COBALT CHROME CABLE W/CLAMP STARTED TO FRAY WHILE TENSIONING. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13655181 ↗
• MalfunctionApr 6, 2021Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT, DURING A THR WHEN THE ACC 2.0MM COCR CABLE W/CLAMP WAS CUT IT FRAYED AT THE END. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS THAN OR EQUAL TO 30MIN USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624909 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING PROCEDURE THE ACC 2.0MM COCR CABLE W/CLAMP WAS CUT OFF WHEN TENSIONER WAS APPLIED. IT HAD BEEN SHIFTED SEVERAL TIMES. INSTRUMENTS INSIDE THE PATIENT. IT CAN NOT DENY POSSIBILITY OF REMAINING IN THE BODY. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS THAN OR EQUAL TO 30MIN WITH A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593536 ↗
• InjuryOct 19, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING SURGERY, THE 2.0 ACCORD CABLE FRAYED WHILE INSIDE THE PATIENT. ITEM WAS RETRIEVED FROM PATIENT AND PROCEDURE CONCLUDED WITH A DELAY OF 5 MINUTES AND WITHOUT AN INJURY. IT IS UNKNOWN IF A BACKUP DEVICE FROM SMITH AND NEPHEW WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10696478 ↗
• MalfunctionSep 30, 2020Break; Break

  IT WAS REPORTED THAT THE CABLE BROKE DURING A REVISION SURGERY (NON S&N DEVICES). NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10604572 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON USED AN ACCORD CABLE, THE CABLE BROKE DURING FASTENING PROCESS. THERE WAS NO INJURY TO PATIENT AND A SECOND IMPLANT WAS AVAILABLE. THERE WAS NO DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319274 ↗
• InjuryJun 18, 2020Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION OF FEMORAL FRACTURE, TWO ACCORD CABLES WERE BROKE INSIDE THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. NO 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 Known Impact Or Consequence To Patient

  MAUDE report 10171577 ↗
• InjuryJun 18, 2020Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION OF FEMORAL FRACTURE, TWO ACCORD CABLES WERE BROKE INSIDE THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. NO 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 Known Impact Or Consequence To Patient

  MAUDE report 10171571 ↗
• MalfunctionDec 20, 2019Break; Break

  IT WAS REPORTED THAT THE CABLE BROKE DURING SURGERY. THERE WAS NO DELAY NOR INJURY REPORTED. THE DEVICE BROKE INSIDE THE PATIENT BUT NO PIECES FELL INSIDE THE INCISION. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9503325 ↗
• MalfunctionSep 24, 2019Break; Break

  IT WAS REPORTED THAT DURING A THR PROCEDURE, CABLE UNRAVELED WHILE TENSIONING AND BROKE. DELAY FROM (0-30) MINUTES REPORTED. NO DELAY. NO IMPACT OR INJURY TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9114228 ↗
• InjurySep 3, 2019Break; Break

  IT WAS REPORTED A REVISION SURGERY DUE TO CUT OUT.

  Patient problems: Injury

  MAUDE report 8955192 ↗
• MalfunctionJul 3, 2019Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED AS THE SURGEON BEGAN TO TENSION THE CABLE AFTER FOLLOWING THE PROTOCOL ON HOW TO PASS IT, THE CABLE BEGAN TO FRAY AND SPLIT. NOTHING VISUALLY WAS CAUSING THE PROBLEM. THE CABLE SCREW WAS UNLOCKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8761644 ↗
• MalfunctionJul 3, 2019Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED AS THE SURGEON BEGAN TO TENSION THE CABLE AFTER FOLLOWING THE PROTOCOL ON HOW TO PASS IT, THE CABLE BEGAN TO FRAY AND SPLIT. NOTHING VISUALLY WAS CAUSING THE PROBLEM. THE CABLE SCREW WAS UNLOCKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8761631 ↗
• MalfunctionJun 26, 2019Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED AS THE SURGEON BEGAN TO TENSION THE CABLE AFTER FOLLOWING THE PROTOCOL ON HOW TO PASS IT, THE CABLE BEGAN TO FRAY AND SPLIT. NOTHING VISUALLY WAS CAUSING THE PROBLEM. THE CABLE SCREW WAS UNLOCKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8738108 ↗
• MalfunctionApr 7, 2019Break; Break

  IT WAS REPORTED THAT DURING THAT DURING THE TREATMENT OF A INTERTROCHANTERIC COMMINUTED FRACTURE, THE CABLE SUDDENLY BROKE. DELAY OF LESS THAN 30MIN REPORTED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489944 ↗
• MalfunctionOct 2, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DEVICE RELEASED DURING PROCEDURE. DELAY OVER 2 HOURS, BACK UP AVAILABLE, NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7929013 ↗
• InjuryAug 23, 2018Loss of or Failure to Bond

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT'S TROCHANTERIC REGION AND GREATER TROCHANTER WAS COMPLETELY UNUNITED. THE CABLES AND CLAW WERE REMOVED. THE TROCHANTERIC NONUNION WAS FIXED BY REAPPROXIMATING THE GREATER TROCHANTER IN THE APPROPRIATE POSITION AND PLACING A NEW CABLE CLAW CONSTRUCT IN THE APPROPRIATE POSITION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7808653 ↗
• InjuryAug 23, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT'S TROCHANTERIC REGION AND GREATER TROCHANTER WAS COMPLETELY UNUNITED. THE CABLES AND CLAW WERE REMOVED. THE TROCHANTERIC NONUNION WAS FIXED BY REAPPROXIMATING THE GREATER TROCHANTER IN THE APPROPRIATE POSITION AND PLACING A NEW CABLE CLAW CONSTRUCT IN THE APPROPRIATE POSITION.

  Patient problems: No Code Available

  MAUDE report 7808643 ↗
• InjuryAug 23, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT'S TROCHANTERIC REGION AND GREATER TROCHANTER WAS COMPLETELY UNUNITED. THE CABLES AND CLAW WERE REMOVED. THE TROCHANTERIC NONUNION WAS FIXED BY REAPPROXIMATING THE GREATER TROCHANTER IN THE APPROPRIATE POSITION AND PLACING A NEW CABLE CLAW CONSTRUCT IN THE APPROPRIATE POSITION.

  Patient problems: No Code Available

  MAUDE report 7808641 ↗
• MalfunctionAug 22, 2018Break; Material Separation

  IT WAS REPORTED THAT METAL THREADS UNBRAIDED WHEN THE SURGEON HAS TIGHTENED AND THE CABLE BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806651 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031162, K211176, K223762, K233949. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.