Arthrex® AR-8929BC-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867131651), received between May 22, 2017 and Dec 1, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Break; Break

  ON 11/11/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE ANCHOR OF THE SWIVELOCK FROM THE AR-8929BC-CP ACHILLES MID SUBSTANCE SPEEDBRIDGE IMPLANT SYSTEM, SNAPPED DURING INSERTION. THE BONE WAS PREPARED, DRILLED, AND TAPPED ACCORDING TO THE RECOMMENDED TECHNIQUE. THE EYELET REMAINED IN PLACE WITH A PARTIAL ANCHOR BECAUSE THE PORTION ALREADY INSERTED COULD NOT BE REMOVED. THIS WAS DISCOVERED DURING AN ACHILLES REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/17/2025: THE SURGEON REPORTED THAT THE ANCHOR OF THE SWIVELOCK FROM THE AR-8929BC-CP ACHILLES MID-SUBSTANCE SPEEDBRIDGE IMPLANT SYSTEM FELT NORMAL RESISTANCE UPON INSERTION. THE ANCHOR WAS PARTIALLY INSERTED WHEN IT BROKE. NO ADDITIONAL PRODUCTS WERE USED TO COMPLETE THE CASE BECAUSE THE ANCHOR REMAINED SECURE WITH PARTIAL INSERTION. THERE WAS A CASE DELAY OF APPROXIMATELY 3¿5 MINUTES, RESULTING IN AN ADDITIONAL 3¿5 MINUTES OF ANESTHESIA. ALL DETACHED FRAGMENTS WERE ACCOUNTED FOR AND RETRIEVED. THE EYELET REMAINED INTACT DURING THE EVENT. BONE PREPARATION FOR IMPLANT INSERTION WAS PERFORMED USING THE INSTRUMENTATION PROVIDED IN THE KIT. THE DRILL, DRILL GUIDE, AND HAND TAP WERE USED; THE POWER T

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23684846 ↗
• MalfunctionMay 1, 2025Break; Break

  ON 4/3/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT ONE OF THE SWIVELOCK ANCHORS FROM AN AR-8929BC-CP ACHILLES MID SUBSTANCE SPEEDBRIDGE IMPLANT SYSTEM BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 4/30/2025.

  Patient problems: Insufficient Information

  MAUDE report 21942405 ↗
• MalfunctionFeb 6, 2025Break; Break

  ON 20TH JANUARY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8929BC-CP, IMPL SYS, BIO-COMP ACHILLES MID-SUBSTANCE WAS BROKEN. THIS WAS DETECTED DURING A TENDON ACHILLES PROCEDURE ON (B)(6) 2025. SWIVELOCK IN AR-8929BC-CP WAS BROKEN DURING IMPLANTATION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM BY USING ANOTHER NEW IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321679 ↗
• MalfunctionJun 18, 2024Melted; Melted

  IT WAS REPORTED THAT THE DEVICE BROKE DURING SCREWING IN AND SHOWS SIGNS OF MELTED MATERIAL. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE ACHILLES SPEED BRIDGE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 18-FEB-2021: THE ANCHOR DIDN`T BRAKE OFF INSIDE THE PATIENT AND THEREFORE NOTHING REMAINED IN THE PATIENT. ONLY THE HANDLE WAS BROKEN. THE SURGERY WENT WITHOUT FURTHER COMPLICATIONS, THEY USED ANOTHER ANCHOR AND NO FURTHER DRILLING WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558146 ↗
• MalfunctionNov 7, 2022Break

  ON 10/18/2022, IT WAS REPORTED BY MEDWATCH VIA EMAIL THAT AN AR-8929BC-CP ACHILLES MID SUBSTANCE SPEEDBRIDGE IMPLANT SYSTEM BROKE IN HALF. SURGEON IDENTIFIED NO INJURY TO THE PATIENT. THIS WAS DISCOVERED DURING AN ACHILLES TENDON REPAIR PROCEDURE ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743479 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem

  ON 5/27/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8929BC-CP ACHILLES MID SUBSTANCE SPEEDBRIDGE IMPLANT SYSTEM WAS IMPLANTED IN THE PATIENT. POST SURGERY, PATIENT EXPERIENCE INFECTION WHICH CAUSED NECROSIS OF THE ACHILLES TENDON. SURGEON IS PLANNING FOR A REVISION SURGERY TO REMOVE THE IMPLANTS, DATE HAVE NOT BEEN PROVIDED AT THIS TIME. SURGEON BECAME AWARE OF THE INFECTION ON (B)(6) 2022.

  Patient problems: Failure of Implant; Necrosis; Unspecified Infection

  MAUDE report 14675404 ↗
• InjurySep 18, 2019Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT AN ACHILLES REPAIR PROCEDURE WHERE A BIO-COMPOSITE ACHILLES MID-SUBSTANCE IMPLANT SYSTEM, AR-8929BC-CP, WAS IMPLANTED. TWO WEEKS AFTER THE SURGERY, THE PATIENT BEGAN TO EXPERIENCE ALLERGIC REACTION-LIKE ERUPTION IN THEIR SKIN. THE AFFECTED AREA HAD REPEATED BLISTERS, RASHES AND RUPTURES WHICH WERE INITIALLY RECOGNIZED THROUGHOUT THE BODY, BUT WERE GRADUALLY CONFINED TO THE WOUND AREA. A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2019 WHERE THE SURGEON EXPLANTED THE IMPLANT. A PATCH TEST WAS PERFORMED ON THE EXTRACTED PRODUCT AND A POSITIVE REACTION WAS OBSERVED. THE PATIENT WAS SEEN ON (B)(6) 2019 AND IT WAS REPORTED THAT THE PATIENT'S CONDITION AFTER REMOVAL WAS GOOD.

  Patient problems: Hypersensitivity/Allergic reaction; Local Reaction

  MAUDE report 9081172 ↗
• InjuryApr 18, 2018Insufficient Device Problem Information

  IT WAS DISCOVERED DURING MAUDE REVIEW AND REPORTED VIA MEDWATCH LETTER (MW5075218) THAT A PATIENT HAD REPORTED THE FOLLOWING INCIDENT: IN 2017 PATIENT HAD SURGERY TO REPAIR PATIENT'S LEFT ACHILLES TENDON WITH A NEW PROCEDURE CALLED "ACHILLES MIDSUBSTANCE SPEEDBRIDGE REPAIR. SURGERY INVOLVED 6 FIBERWIRES FROM THE TOP OF THE ACHILLES ATTACHED TO THE LOWER ACHILLES WITH NO KNOTS AND ANCHORED IN PATIENT'S HEEL. AFTER 5 MONTHS POST SURGERY PATIENT NOTICED THAT A BLISTER DEVELOPED AND STARTED TO DRAIN ON THE INCISION SITE. PATIENT'S DOCTOR SUGGESTED IT WAS INFECTED AND PRESCRIBED ANTIBIOTICS FOR ONE MONTH. THE WOUND WOULD NOT STOP DRAINING FOR 3 MONTHS. PATIENT VISITED DOCTOR AGAIN AND DOCTOR SUGGESTED IT WAS PATIENT'S UPPER SKIN THAT WAS ALLERGIC TO THE FIBERWIRES THAT WAS HOLDING PATIENT'S ACHILLES TOGETHER. THERE ARE 2 SETS OF WIRES, ONE SET ON PATIENT'S LEFT SIDE OF HEEL AND ANOTHER ON THE RIGHT SIDE. EACH SET OF WIRES CONSIST OF 3 FIBERWIRES. PATIENT'S DOCTOR CUT AND EXTRACTED AS FAR BACK AS SHE COULD WITHOUT GOING TO OPERATING TABLE AND STITCHED PATIENT UP. CURRENTLY PATIENT REPORTED TO BE STILL LIMPING FROM THE WIRE EXTRACTION. DOCTOR TOLD PATIENT IT WILL TAKE TIME FOR TENDON TO G

  Patient problems: Fluid Discharge; Reaction; Swelling

  MAUDE report 7439292 ↗
• InjuryDec 27, 2017Device Operates Differently Than Expected; Material Protrusion/Extrusion

  IT WAS REPORTED BY PATIENT'S SPOUSE THAT THE PATIENT HAD AN ACHILLES SPEEDBRIDGE REPAIR ON (B)(6) 2017. THE SURGERY SITE WAS NOT HEALING AND A PIECE OF YELLOW MATERIAL (BELIEVED TO BE AT LEAST A PORTION OF THE BANANA SUTURE LASSO HANDLE OF THE DEVICE) BEGAN TO PROTRUDE OUT OF PATIENT'S INCISION SITE. IN (B)(6) 2017 DURING A FOLLOW UP VISIT AT SURGEON'S OFFICE THE SURGEON REMOVED THE YELLOW OBJECT IN PIECES BY DIGGING IT OUT. PATIENT LATER HAD AN EXTENSIVE DEBRIDEMENT PERFORMED BY A DIFFERENT SURGEON. PATIENT IS REPORTED TO NOW HAVE OSTEOMYELITIS AS WELL. FOLLOW-UP INVESTIGATION: ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2017, NOT (B)(6) 2017 AS INITIALLY REPORTED. DURING ORIGINALLY SURGERY THE FOLLOWING DEVICES WERE IMPLANTED: AR-8929BC-CP AND AR-8860DS. PATIENT STATES THAT WHEN REVIEWING HIS ORIGINAL SURGEON OFFICE RECORDS HE HAS DISCOVERED THAT THERE WAS NO NOTATION DEALING WITH HIS AUGUST FOLLOW UP DURING WHICH THE SURGEON DUG OUT THE YELLOW PIECES FROM HIS INCISION SITE. PATIENT NOTED THAT THE PIECES DUG OUT WERE IMMEDIATELY DISCARDED BY THE SURGEON AT HIS OFFICE AND WERE NOT SENT FOR EVALUATION OR CULTURE. LEADING UP TO THE AUGUST APPOINTMENT THE PATIENT STATES HIS INCISION SITE W

  Patient problems: Impaired Healing; Pain; Wound Dehiscence

  MAUDE report 7147520 ↗
• InjuryJul 19, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT IS A YEAR OUT FROM HER SURGERY THAT INVOLVED A SPEEDBRIDGE. SHE WAS INQUIRING IF THE SPEEDBRIDGE WAS A BIO PRODUCT OR A BIO-COMPOSITE PRODUCT. FOLLOW UP INVESTIGATION: IT WAS REPORTED THAT THE PATIENT IS A YEAR OUT FROM HER RESECTION OF RETRO CALCANEAL SPUR AND HAGLUND DEFORMITY WITH DETACHMENT AND REATTACHMENT OF ACHILLES TENDON ON THE RIGHT FOOT. THE PATIENT IS EXPERIENCING SWELLING OVER THE SURGICAL AREA AND ALSO HAS SOME ELEVATED TITER'S THAT MAY BE SHOWING AN INFLAMMATORY RESPONSE.

  Patient problems: Inflammation; Swelling; Test Result

  MAUDE report 6724219 ↗
• InjuryMay 22, 2017Loose or Intermittent Connection; Material Rupture

  IT WAS REPORTED BY THE PATIENT VIA EMAIL THAT AN ARTHREX SPEEDBRIDGE WAS IMPLANTED AFTER AN ACHILLES RUPTURE ABOUT A YEAR PRIOR (~ (B)(6) 2016). PATIENT HAS BEEN SUFFERING FROM WOUND HEALING DISORDER AND PAIN SINCE THE SURGERY. ON ABOUT (B)(6) 2017, ANCHOR GOT LOOSE WHEN THE WOUND WAS BEING CLEANED / DISINFECTED. WOUND ALSO IS INFLAMED. PART NUMBER WAS CONFIRMED TO BE THE ACHILLES SPEEDBRIDGE.

  Patient problems: Impaired Healing; Inflammation; Pain

  MAUDE report 6580999 ↗