Arthrex® AR-8950SD-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867220010), received between Jan 16, 2023 and Apr 6, 2026 — classified as 5 malfunctions.

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

• MalfunctionApr 6, 2026Break

  ON (B)(6) 2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8950SD-10 STRAIGHT, SOLID T10 HEXALOBE SHAFT BROKE DURING A HARDWARE REMOVAL. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792319 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT DURING THE DISTAL TIBIAL FRACTURE SURGERY, THE TIP OF THE DEVICE BROKE OFF AND REMAINED IN THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE 19-FEB-2026, FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE DISTAL TIBIAL FRACTURE SURGERY, THE TIP OF THE DEVICE BROKE OFF AND BECAME LODGED IN THE PATIENT'S SCREW. THE BROKEN PIECE IS THEREFORE LOCATED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: Foreign Body In Patient

  MAUDE report 24567928 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A METAL REMOVAL SURGERY A PART OF THE DEVICE BROKE OFF. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474056 ↗
• MalfunctionAug 18, 2023Break; Break

  ON 07/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8950SD-10 T10 HEXALOBE SHAFT HAD AN ISSUE. DURING AN UNKNOWN PROCEDURE, WHEN TRYING TO REMOVE A 3.5 HEADLESS COMPRESSION FT SCREW, PART OF THE TIP BROKE OFF IN THE SCREW. THEY WERE ABLE TO USE A DENTAL PICK AND GET THE PIECE OUT AND USED ANOTHER DRIVER HANDLE. PART OF THE SCREW ENDED UP BREAKING AS WELL BUT LEFT HALF OF THE SCREW IN. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.ON 8/1/2023, THE SALES REPRESENTATIVE STATED THE FOLLOWING ADDITIONAL INFORMATION OVER THE PHONE: THIS OCCURRED DURING A REVISION SURGERY. THE INITIAL MIDFOOT FUSION SURGERY WITH UNKNOWN ARTHREX PARTS TOOK PLACE WITHIN THE LAST YEAR AND WAS SUCCESSFUL, BUT THE PATIENT AFTERWARD STILL EXPERIENCED PAIN. DURING THE REVISION SURGERY, THE SURGEON REMOVED A COMPRESSION DYNANITE PLATE AND TRIED TO REMOVE TWO AR-8730-32H MINI COMPRESSION FT SCREWS. WHEN TRYING TO REMOVE THE FIRST SCREW, THE TIP OF THE HEXALOBE SHAFT BROKE OFF IN THE SCREW, BUT THEY WERE ABLE TO REMOVE THAT FRAGMENT FROM THE SCREW BY USING A DENTAL PICK. WHEN A DRIVER HANDLE WAS USED TO REMOVE THAT FIRST SCREW AFTERWARD, ABOUT 1 IN

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 17571409 ↗
• MalfunctionJan 16, 2023Break

  ON 12/30/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT A AR-8950SD-10 T10 HEXALOBE SHAFTS TIP OF THE DRIVER BROKE. THIS OCCURRED DURING A CASE WHILE PUTTING A 2.7MM LOCKING SCREW IN THE DISTAL END OF THE PLATE, THE TIP OF THE SCREW DRIVER BROKE WITHIN THE SCREW. THEY NOTICED AND TRIED TO REMOVED WITHOUT SUCCESS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 16173478 ↗