Arthrex® AR-8912DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867048850), received between Oct 21, 2016 and Dec 12, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2023Break; Break

  ON 11/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8912DS MINI TIGHTROPE FIBERWIRE SNAPPED WHEN UNDER TENSION. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED BY FILLING BONE VOID WITH ALLOSYNC. DELAY OVER 15 MINUTES.C THE DEVICE WAS NOT REPLACED, THE SURGEON WAS ABLE TO TETHER OFF OF ANOTHER TIGHTROPE THAT WORKED. DELAY WAS A DEVIATION FROM THE PROCEDURE TO USE ALLOSYNC, WHICH IS NOT COMMON TO A LISFRANK PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314314 ↗
• InjuryMay 3, 2018Break; Detachment Of Device Component; Entrapment of Device

  IT WAS REPORTED THAT THE SURGEON WAS USING THE TIGHTROPE FT FOR A LISFRANC REPAIR. HE PLACED THE WIRE, DRILLED WITH THE 2.7MM DRILL AND THEN THE 4.5MM DRILL. HE THEN TAPPED (ON POWER AS NO HANDLE WAS AVAILABLE), CHECKING EVERYTHING UNDER FLUROSCOPY. HE THEN STARTED TO INSERT THE BIO TIGHTROPE FT AND HEARD A CLICK AND FELT THE SCREWDRIVER DISENGAGE. HE CHECKED WITH FLUROSCOPY AND SAW THAT THE TIP OF THE DRIVER HAD SNAPPED OFF. THE SCREW WAS HOLDING, BUT MAY NOT HAVE BEEN ALL THE WAY ACROSS THE JOINT. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. THE SURGEON COULD NOT DO ANYTHING ELSE, SO LEFT IT IN PLACE.. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. FOLLOW-UP INVESTIGATION: THE TIP/DRIVER PART OF THE SCREWDRIVER, WHICH SITS INSIDE THE SCREW BROKE-OFF AND REMAINS IN THE PATIENT. NOTHING ELSE BROKE OFF, SO IT IS JUST THE METAL PART OF THE SCREWDRIVER THAT IS IN THE PATIENT. THE SURGEON WAS HAPPY WITH THE REDUCTION AND COULD NOT SEE ANYWAY TO REMOVE THE DRIVER TIP THAT WAS LEFT BEHIND.

  Patient problems: Foreign Body In Patient

  MAUDE report 7483534 ↗
• InjuryOct 21, 2016Break; Detachment Of Device Component; Entrapment of Device

  IT WAS REPORTED THAT DURING A LIS FRANC DISLOCATION REPAIR PROCEDURE, THE SURGEON PLACED A REGULAR TIGHTROPE FOR INITIAL FIXATION WITH NO ISSUES, HOWEVER, WHEN HE WENT TO APPLY THE MINI TIGHTROPE FT, THE SCREWDRIVER FELT AS IF IT WAS GETTING WEAK OR THE ANCHOR WAS STRIPPING. THE SURGEON PULLED THE ANCHOR OUT AND RE-INSERTED WHEN THE TIP OF THE DRIVER BROKE-OFF INTO THE SCREW. THE TIP OF THE DRIVER WAS LEFT INSIDE OF THE SCREW TO AVOID A 2ND INCISION AND POSSIBLE HARM TO THE PATIENT. THE TIP OF THE DRIVER IS CLEARLY VISIBLE ON THE PATIENT'S X-RAY. THE TIGHTROPE MECHANISM WAS STILL INTACT. THE BUTTON WAS SLID DOWN TO THE BONE AND REDUCTION WAS ACHIEVED TO COMPLETE THE CASE. FINAL X-RAYS SHOWED THE DISLOCATION HAD BEEN REDUCED. PATIENT IS A (B)(6) MALE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6048636 ↗