Arthrex® AR-8914DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867048881), received between Apr 20, 2018 and Apr 22, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A CARPOMETACARPAL (CMC) HAND MINITIGHTROPE REFIXATION SURGERY THE TIGHTOPE TORE UNDER X-RAY CONTROL. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155427 ↗
• InjuryDec 2, 2020Break

  IT WAS REPORTED THAT DURING A (B)(6) 2020 PROCEDURE WHILE THE SURGEON WAS ADVANCING THE K-WIRE FROM THE AR-8914DS (MINI TIGHTROPE IMPLANT SYSTEM) THROUGH THE SECOND METACARPAL HARD BONE WAS ENCOUNTERED AND THE TIP OF THE K-WIRE BROKE OFF INTO THE METACARPAL. AFTER FLUOROSCOPIC EXAMINATION AND DISCUSSION, THE SURGEON WAS FORCED TO LEAVE THE TIP OF THE K-WIRE IN THE PATIENT'S SECOND METACARPAL. ADDITIONAL INFORMATION OBTAINED 11/16/2020: PROCEDURE WAS A CMC SUSPENSIONPLASTY. LOT NUMBER OF THE K-WIRE WAS NOT RECORDED. REMAINING K-WIRE WAS DISCARDED IN A SHARPS BOX AND IS NOT AVAILABLE TO RETURN.

  Patient problems: Foreign Body In Patient

  MAUDE report 10934364 ↗
• InjuryMar 26, 2020Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION BASAL JOINT ARTHROPLASTY WITH SUSPENSIONPLASTY PROCEDURE WAS PERFORMED ON A PATIENT ON (B)(6) 2020, WHERE A MINI TIGHTROPE, AR-8914DS, WAS EXPLANTED. NO FURTHER DETAILS, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2020: THE PATIENT UNDERWENT A BASAL JOINT ARTHROPLASTY WITH SUSPENSIONPLASTY PROCEDURE ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT STARTED TO NOTICE SWELLING OVER THE (LEFT THUMB) BASAL JOINT AREA AND EXPERIENCED PAIN AND POPPING. THE PATIENT DOES NOT RECALL ANY NEW SPECIFIC TRAUMA OR INJURY. SHE HAS BEEN USING THE BRACE PROVIDED BY THE SURGEON, ESPECIALLY WHEN SHE WAS LIFTING UP KIDS FOR HER WORK. THE SURGEON EXPLAINED TO THE PATIENT THAT THE ENDOBUTTON APPEARED TO BE LOSE AND THAT IS WHAT IS BOTHERING HER, CAUSING A CYST. PER THE SURGEON, THE THUMB APPEARS STABLE AND THERE IS A GOOD GAP AT THE BASAL JOINT AREA IN SPITE OF THE TIGHTROPE NOT WORKING. SURGEON SUGGESTED THAT THE HARDWARE BE REPLACED. REVISION SURGERY WAS PERFOMRED ON (B)(6) 2020. OPERATIVE REPORT (B)(6) 2020: SURGEON NOTED THE FOLLOWING ON THE OPERATIVE REPORT: "AT THIS STAGE, I NOTICED THAT THE BUTTON WAS NOT AT THE BASE OF THE FIRST METACARPAL A

  Patient problems: Cyst(s); Pain; Swelling

  MAUDE report 9883007 ↗
• InjuryAug 22, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BUNIONECTOMY ON HER RIGHT FOOT ON (B)(6) 2017 WHERE A MINI TIGHTROPE, AR-8914DS, WAS IMPLANTED. ABOUT TWO MONTHS POST-OP, IN (B)(6), THE PATIENT BEGAN TO EXPERIENCE RASH-LIKE SYMPTOMS BEGINNING AT THE TOP OF HER FOOT NEAR THE INCISION SITE. SHE WENT TO SEE HER SURGEON WHO PRESCRIBED HER A TOPICAL OINTMENT. THE OINTMENT RELIEVED THE SYMPTOMS BUT DID NOT CURE THE RASH. SHE THEN WENT TO THE ER WHERE SHE WAS PRESCRIBED ANOTHER TOPICAL OINTMENT. THIS PRESCRIPTION ALSO ONLY RELIEVED THE SYMPTOMS. THE PATIENT HAS ALSO SEEN A DERMATOLOGIST AND AN ALLERGIST AND HAS NOT BEEN ABLE TO CURE THE RASH THAT HAS NOW TURNED INTO BLISTERS.

  Patient problems: Rash; Swelling

  MAUDE report 7806010 ↗
• InjuryApr 20, 2018Stretched; Device Operates Differently Than Expected; Material Twisted/Bent

  IT WAS REPORTED BY PATIENT THAT SHE HAD A PROCEDURE ON HER LEFT THUMB ON (B)(6) 2015 DURING WHICH TIME AN ARTHREX TIGHTROPE WAS IMPLANTED. APPROXIMATELY 6 MONTHS PRIOR TO REPORTING THIS INCIDENT THE PATIENT BEGAN TO HAVE TREMENDOUS PAIN. SHE HAD AN X-RAY TAKEN AND ORIGINAL SURGEON INFORMED HER THAT HER REPAIR HAD FAILED AND THAT THE TIGHTROPE CONSTRUCT HAD STRETCHED. SINCE HER ORIGINAL SURGEON IS NOT ACCEPTING MEDICARE SHE HAD A REVISION SURGERY PERFORMED BY ANOTHER SURGEON ON (B)(6) 2017. THE REVISION SURGEON INFORMED PATIENT THAT THE CONSTRUCT OF THE DEVICE WAS OUT OF SHAPE, TWISTED AND STRETCHED. THE REVISION WAS COMPLETED BY THE NEW SURGEON USING A COMPLETELY DIFFERENT METHOD WHICH INVOLVED USING CADAVER PARTS. PART NUMBERS PROVIDED (B)(6) 2018: (B)(4) IMPLANT SYSTEM, MINI TIGHTROPE, LOT 1146784. THE FOLLOWING INFORMATION WAS OBTAINED FROM PATIENT MEDICAL REPORTS: OP REPORT (B)(6) 2015 - PROCEDURE: LEFT BASAL JOINT ARTHROPLASTY REVISION, TIGHTROPE PROCEDURE. PATIENT HAS FAILED APPROXIMATELY FOUR OPERATIONS PRIOR DONE ELSEWHERE INCLUDING BASAL JOINT ARTHROPLASTY, TENDON GRAFTING (PER PATIENT THESE PREVIOUS SURGERIES DID NOT INVOLVED ARTHREX PRODUCTS AND USED HER OWN TENDONS FOR

  Patient problems: Pain

  MAUDE report 7447637 ↗