Arthrex® AR-8928BCJ-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867251991), received between Apr 18, 2018 and Aug 18, 2023 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 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.

• MalfunctionAug 18, 2023Component Missing; Component Missing

  ON 7/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8928BCJ-CP ACHILLES SPEEDBRIDGE KIT WAS MISSING THE GREEN DRILL GUIDE AND THERE WAS AN EXTRA POWER TAP. THIS WAS DISCOVERED UPON OPENING THE PACKAGE DURING A HAGLUND AND ACHILLES PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED BY OPENING ANOTHER KIT.

  Patient problems: Insufficient Information

  MAUDE report 17571361 ↗
• MalfunctionMay 10, 2023Break; Break

  ON 4/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8928BCJ-CP IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP ANCHOR BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING A SINGLE SWIVELOCK. THIS WAS DISCOVERED DURING AN ACHILLES SPEEDBRIDGE PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16905097 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem

  ON 10/31/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8928BCJ-CP ACHILLES SPEEDBRIDGE IMPLANT SYSTEM WAS EXPLANTED DURING A REVISION SURGERY ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 10/31/2022. AN AR-8928BCJ-CP ACHILLES SPEEDBRIDGE IMPLANT SYSTEM AND AN ABS-4200-034 AMNION WERE IMPLANTED DURING ORIGINAL PROCEDURE ON 2/18/2022. DUE TO CHRONIC INFLAMMATION AND PAIN, REVISION SURGERY WAS PERFORMED, AND AR-8928BCJ-CP WAS REMOVED. BOTH SURGERIES OCCURRED AT THE SAME FACILITY.

  Patient problems: Inflammation; Pain

  MAUDE report 15834873 ↗
• MalfunctionAug 4, 2022Patient-Device Incompatibility

  ON (B)(6) 2022, IT WAS REPORTED BY THE PATIENT VIA EMAIL THAT AFTER UNDERGOING A PROCEDURE ON HER LEFT HEEL UTILIZING ARTHREX¿S SPEEDBRIDGE/FIBERWIRE SHE HAS SUFFERED A REACTION TO THE SUTURE MATERIAL IMPLANTED. THE PATIENT HAS SINCE UNDERGONE TWO PROCEDURES, INCLUDING AN I & D FOR MRSA, AS A RESULT OF A HYPERSENSITIVITY TO THE FIBERWIRE. ADDITIONAL INFORMATION RECEIVED ON 7/12/2022: THE PATIENT FURTHER REPORTED THAT THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2022. THEREAFTER, ON MAY 4TH, THE PATIENT WENT BACK TO GET THE STAPLES REMOVED AND THE WOUND APPEARED TO BE HEALING SLOWLY. THEN ON MAY 12 IT WAS FOUND THAT THE PATIENT DEVELOPED A REACTION DUE TO NON-CLOSURE OF SURGICAL WOUND. ON MAY 18TH THE SURGEON EXAMINED THE WOUND AGAIN, WHICH AT THIS POINT WAS SIGNIFICANTLY OPENED. IT WAS CLEANED OUT AND THE SURGEON INDICATED THAT THE INTERNAL SUTURES SEEMED TO BE IRRITATING THE SURROUNDING TISSUE. THE PATIENT BEGAN TAKING KEFLEX ANTIBIOTICS AND REPORTED THAT OVER THE NEXT 36 HOURS, THE PAIN AND SWELLING IN THE FOOT BECAME UNBEARABLE. THE PATIENT WENT BACK TO SEE THE SURGEON ON MAY 19TH, AND AN I & D PROCEDURE WAS PERFORMED AND CULTURES CAME BACK POSITIVE FOR MRSA. THE PATIENT WAS THEN

  Patient problems: Drug Resistant Bacterial Infection; Hypersensitivity/Allergic reaction; Laceration(s); Pain; Swelling/ Edema

  MAUDE report 15163931 ↗
• InjuryDec 9, 2019Product Quality Problem

  IT WAS REPORTED THAT BONESYNC, ABS-3103, WAS BEING USED IN AN ANKLE CASE. THE PATIENT HAD A PREVIOUS CALCANEAL FRACTURE, THAT WAS AGAIN REFRACTURED AT THE INSERTION SITE OF THE ACHILLES TENDON. THE LARGE FRAGMENT WAS PINNED AND PATIENT RETURNED FOR REPAIR OF THE ACHILLES¿ TENDON. PATIENT HAS A HISTORY OF SMOKING. AFTER INSERTION OF THE FIRST ANCHOR OF THE SPEEDBRIDGE IMPLANT SYSTEM, THE ANCHOR PULLED OUT DUE TO VERY POOR BONE QUALITY. THE SURGEON INCREASED THE SIZE OF THE ANCHOR TO A 5.5 SWIVELOCK, BUT ULTIMATELY, IT STILL PULLED OUT. AT THIS POINT, THE REP RECOMMENDED THE USE OF BONE SYNC. AFTER QUICK APPROVAL FROM THE FACILITY, THE REP RETRIEVED 3CC OF BONESYNC, ABS-3103. HE REVIEWED THE INDICATIONS AND TECHNIQUE PROVIDED BY ARTHREX AND AFTER DISCUSSING WITH THE DOCTOR AND DUE TO TIME SENSITIVITY (PATIENT WAS ON THE TABLE FOR AN HOUR AND A HALF AT THIS POINT), SURGEON DECIDED TO USE ROOM TEMPERATURE SALINE INSTEAD OF BLOOD - BOTH INDICATED AND VIABLE SOLUTIONS TO USE WHEN MIXING WITH THE BONE CEMENT POWDER. SURGEON MIXED 3CC OF BONESYNC WITH 2.8CC OF SALINE (2.6CC FOR FASTER SETTING, 2.8CC FOR FACILITATED MIXING REQUIRING A SLIGHTLY LONGER SET TIME). REP WHO WAS PRESENT STATED TH

  Patient problems: Failure of Implant

  MAUDE report 9438097 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACHILLES TENDON REPAIR PROCEDURE ON (B)(6) 2018. THE CASE WENT SMOOTH. THE SURGEON REMOVED THE BONE SPURS AND USED AN ACHILLES SPEEDBRIDGE, AR-8928BCJ-CP, TO REPAIR THE ACHILLES TENDON. THE SURGEON THEN USED AFLEX201 FOR ADDITIONAL REINFORCEMENT OF THE ACHILLES. FOUR MONTHS POST-OP, THE PATIENT IS SHOWING AN INFLAMMATORY REACTION AT THE SURGICAL SITE. THERE IS ALSO BONE DISTRACTION AS WELL. THE SURGEON PUT THE PATIENT INTO THE HOSPITAL FOR A BONE BIOPSY AND THREE PHASE BONE SCAN TO DIFFERENTIATE BETWEEN AN IMPLANT REACTION OR OSTEOMYELITIS. ADDITIONAL INFORMATION PROVIDED 6/26/2018: THE SURGEON HAS ONLY REMOVED THE AFLEX ONLY AT THIS POINT (REMOVED ON (B)(6) 2018). THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND STAYED A TOTAL OF 5 DAYS. NO PHOTOS OF THE REACTION WERE TAKEN.

  Patient problems: Inflammation; Reaction

  MAUDE report 7684938 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACHILLES DEBRIDEMENT AND REMOVAL OF HAGLUNDS DEFORMITY WITH A GASTRIC LENGTHENING PROCEDURE AND THERE WERE NO ISSUES IMPLANTING THE ACHILLES SPEEDBRIDGE AND AMNION. THE PATIENT DID WELL POST-OPERATIVELY UNTIL 6/4/2018 (4 WEEKS POST-OP) WHEN THEY RETURNED TO THE CLINIC WITH AN OPEN WOUND AROUND THE ACHILLES INSERTION. THE SURGEON NOTED THAT IT DIDN¿T LOOK INFECTED AND HAD IT CULTURED TO FIND OUT. HE NOTIFIED THE REP AFTER THE PATIENT¿S APPOINTMENT AND WAS WONDERING IF THERE MIGHT BE AN ISSUE WITH THE AMNION AND/OR ACHILLES SPEEDBRIDGE. HE REQUESTED THAT THEY TAKE A FURTHER LOOK INTO IT. SURGEON THINKS IT MAY BE A HEMATOMA THAT CAUSED THE ISSUE BUT THE PATIENT HAS HAD NO PAIN UNTIL NOW. THE PATIENT IS CURRENTLY GOING TO A WOUND CLINIC FOR A WOUND VAC. PATIENT HAS BEEN ON ASPIRIN FOR DVT. THE SURGEON DOESN¿T BELIEVE THE AMNION IS THE PROBLEM AND THE PATIENT LOOKED GOOD UNTIL COMING INTO HIS CLINIC ON (B)(6) 2018. PATIENT ALSO HAD A SIMILAR ISSUE WITH A PREVIOUS ACHILLES SURGERY ON HER RIGHT LEG. NO AMNION WAS USED ON THE RIGHT LEG WHEN IT WAS DONE.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 7629355 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT ACCORDING TO THE SURGEON THE PATIENT HAS HAD A REACTION TO THE MATERIAL AND IS HAVING A REVISION DONE. REPRESENTATIVE DID NOT HAVE ALL DETAILS AT THE TIME OF THE INITIAL REPORT BECAUSE THE REVISION HAD NOT STARTED YET AT THE TIME OF THE REPORT. FOLLOW-UP INVESTIGATION: THE EXPLANTED DEVICE HAS BEEN CONFIRMED TO BE AR-8928BCJ-CP, LOT 10129351. ORIGINAL SURGERY TOOK PLACE (B)(6) 2017. APPROXIMATELY (B)(6) 2017 THE PATIENT BEGAN TO EXPERIENCE PAIN, SENSITIVITY, SWELLING AND TIGHTNESS WHICH CONTINUED THROUGH MARCH. ON (B)(6) 2018 THE PATIENT'S ORIGINAL SURGERY REPAIR HAD HEALED AND THE PATIENT UNDERWENT A REVISION PROCEDURE. THE SURGEON REMOVED THE ORIGINAL IMPLANT AND FLUSHED THE AREA OUT. BOTH PROCEDURES TOOK PLACE AT THE SAME FACILITY.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Reaction; Swelling

  MAUDE report 7439297 ↗