Arthrex® AR-8934BCNFRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867050365), received between Feb 25, 2020 and Feb 3, 2025 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8934BCNF SMALL JOINT BIOCOMPOSITE SUTURETAK® WITH NEEDLES BROKE. THIS OCCURRED DURING USE THEY PREVIOUSLY MADE THE BROCADE AND PREPARATION OF THE INSERTION SITE AND AT THE MOMENT OF IMPACT THE DEVICE BROKE. ANOTHER ANCHOR WAS PASSED TO THE SURGEON WITH WHICH HE FINISHED THE PROCEDURE WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293461 ↗
• MalfunctionOct 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8934BCNF SMALL JOINT BIOCOMPOSITE SUTURETAK ANCHOR PULLED OUT. AFTER THE IMPLANT WAS INSERTED INTO THE TUNNEL AND MALLETED FLUSH TO THE LASER LINE, THE SURGEON TUGGED LIGHTLY ON THE NUMBER ONE FIBERWIRE TO CHECK FOR ANCHOR SECURITY; AT THIS TIME, THE ANCHOR PULLED OUT, AND IT APPEARED THE BIOCOMPOSITE HAD BEEN SLIGHTLY COMPROMISED. THE CASE WAS COMPLETED USING A NEW ANCHOR. THIS WAS DISCOVERED DURING AN EXTENSOR TAKEDOWN AND REPAIR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 10/2/2023: THE CASE WAS COMPLETED USING ANOTHER AR-8934BCNF SMALL JOINT BIOCOMPOSITE SUTURETAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996439 ↗
• MalfunctionApr 18, 2022Break; Material Twisted/Bent

  ON 3/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8934BCNF BIOCOMPOSITE SUTURETAK BENT AND BROKE WHEN SURGEON HIT IT WITH A MALLET DURING INSERTION. ALL BROKEN FRAGMENTS WERE RETRIEVED AND CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER AR-8934BCNF BIOCOMPOSITE SUTURETAK FROM THE SAME LOT NUMBER. THIS WAS DISCOVERED DURING A BROSTROM ANKLE REPAIR ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135360 ↗
• MalfunctionOct 11, 2021Break

  IT WAS REPORTED ON (B)(6) 2021 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8934BCNF SUTURE ANCHOR BROKE DURING USE. AFTER FIXING THE ANKLE ORIF, THE SURGEON INCISED MEDIALLY AND RESECTED THE PARTIALLY-TORN DELTOID LIGAMENT. THE TIBIAL FOOTPRINT WAS DRILLED WITH THE 2.5 MM DRILL BIT AND GUIDE FROM THE AR-8934DSC KIT, AND THE ANCHOR WAS INSERTED AS PER USUAL. THE 1ST ANCHOR BROKE OFF THE INSERTER AS IT WAS MALLETED INTO THE BONE TUNNEL, AND THE 2ND BROKE INSIDE THE BONE TUNNEL AFTER IT WAS INSERTED ~50%.THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 12608755 ↗
• MalfunctionAug 24, 2021Break

  IT WAS REPORTED THAT DURING AN ANKLE FRACTURE/LIGAMENT REPAIR SURGERY THE SURGEON DRILLED THE BONE USING THE BONE DRILL FROM THE DRILL KIT. UPON INSERTION, THE DEVICE BROKE OFF AND CRUMBLED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE 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.

  Patient problems: Insufficient Information

  MAUDE report 12361332 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT ANKLE ARTHROSCOPY WITH DEBRIDEMENT AND LATERAL LIGAMENT RECONSTRUCTION. THE DATE OF SURGERY WAS (B)(6) 2021. THE PATIENT HAS DEVELOPED AN INFECTION AT THE SITE. THIS WAS SEEN BY THE SURGEON AT A FOLLOW UP APPOINTMENT. THE PATIENT IS MALE, (B)(6) YEARS AND PRESENTED WITH OSTEOMYELITIS; HE IS BEING TREATED WITH ANTIBIOTICS AND IS DOING WELL TO DATE. THERE ARE NO PLANS TO REMOVE THE IMPLANT.

  Patient problems: Osteomyelitis

  MAUDE report 11842409 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT ANKLE ARTHROSCOPY WITH DEBRIDEMENT AND LATERAL LIGAMENT RECONSTRUCTION.; DATE OF SURGERY WAS (B)(6) 2021. THE PATIENT HAS DEVELOPED AN INFECTION AT THE SITE. THIS WAS SEEN BY THE SURGEON AT A FOLLOW UP APPOINTMENT. THE PATIENT IS MALE, (B)(6) YEARS AND PRESENTED WITH OSTEOMYELITIS; HE IS BEING TREATED WITH ANTIBIOTICS AND IS DOING WELL TO DATE. THERE ARE NO PLANS TO REMOVE THE IMPLANT.

  Patient problems: Osteomyelitis

  MAUDE report 11842389 ↗
• InjuryMar 9, 2020Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD ANKLE RECONSTRUCTION SURGERY A FEW YEARS AGO UTILIZING ARTHREX PRODUCTS. SINCE SURGERY SHE HAS DEVELOPED REACTION TYPE SYMPTOMS WHICH INCLUDE RASHES AT THE SURGICAL SITE. PATIENT IS SEEKING MATERIAL COMPOSITION OF THE DEVICES. PATIENT WILL PROVIDE ADDITIONAL INFORMATION VIA EMAIL AND WILL OBTAIN THE SPECIFIC PART NUMBERS INVOLVED TO PROVIDE TO ARTHREX. ADDITIONAL INFORMATION OBTAINED 02/17/2020: PATIENT'S SURGERY TOOK PLACE (B)(6) 2013. PROCEDURE WAS ON HER RIGHT FOOT. SHE HAD AN ACCESSORY NAVICULAR REMOVED AND THE ARCH IN HER FOOT WAS CORRECTED. PATIENT REPORTS HER ANKLE HAS ALWAYS BEEN TENDER BUT SHE FIGURED THAT WAS NORMAL (LONG LASTING EFFECTS OF SURGERY). SHE BEGAN HAVING RASHES ON HER KNUCKLES AROUND THE END OF 2016. IN THE PAST YEAR SHE HAS HAD RASHES ON HER SHINS; WHAT LOOKS LIKE POLPHOLYX ON HER FINGERS THAT COMES AND GOES; AND A SMALL PATCH OF DRY/ CRUSTY SKIN ON HER OUTER RIGHT ANKLE. THE ONLY THING THAT SEEMS TO HELP THE PATIENT IS ORAL BENADRYL. IN (B)(6) 2018 PATIENT'S EYESIGHT SUDDENLY BECAME SENSITIZED TO HIGH CONTRACT IMAGES/ LIGHTING. PATIENT HAS HEADACHES MORE OFTEN THAN EVER BEFORE. PATIENT'S OPHTHALMOLOGIST SAYS THE S

  Patient problems: Headache; Rash; Reaction; Visual Impairment

  MAUDE report 9805028 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 3 WEEKS POST-OP FROM AN ELBOW PROCEDURE IT WAS DISCOVERED THE TENDON TORE THROUGH THE SUTURE. A REVISION PROCEDURE WAS NEEDED TO REMOVE THE SUTURES. THE FIRST ANCHOR REMAINED IMPLANTED BUT ANOTHER HOLE WAS DRILLED TO INSERT ANOTHER ANCHOR AND TIE OVER A GRAFT. ADDITIONAL INFORMATION 02-04-2020: ORIGINAL OP DATE: (B)(6), REVISION DATE: (B)(6). PT HAS NOT BEEN SEEN YET FOR FOLLOW UP.

  Patient problems: Tissue Damage

  MAUDE report 9750574 ↗
• InjuryFeb 25, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED 3 WEEKS POST-OP FROM AN ELBOW PROCEDURE IT WAS DISCOVERED THE TENDON TORE THROUGH THE SUTURE. A REVISION PROCEDURE WAS NEEDED TO REMOVE THE SUTURES. THE FIRST ANCHOR REMAINED IMPLANTED BUT ANOTHER HOLE WAS DRILLED TO INSERT ANOTHER ANCHOR AND TIE OVER A GRAFT. ADDITIONAL INFORMATION 02-04-2020: ORIGINAL OP DATE: (B)(6) 2019, REVISION DATE: (B)(6), PT STATUS PER THE DOCTOR'S FOLLOW UP: STATUS: DOING GREAT.

  Patient problems: No Code Available

  MAUDE report 9750562 ↗