Arthrex® AR-8730-32HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867127050), received between Feb 19, 2019 and Jan 12, 2024 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2024Break; Break

  ON 12/14/2023, IT WAS REPORTED BY A DISTRIBUTOR THAT AN AR-8730-32H MINI COMPRESSION FT SCREW BROKE. THIS OCCURRED DURING A NAVICULAR FRACTURE ON (B)(6) 2023, WHERE THE NAVICULAR WAS PROPERLY REDUCED AND DRILLED. UPON INSERTING THE SCREW, THE FIRST SCREWDRIVER USED WAS STRIPPED. A SECOND DRIVER WAS USED BUT BEGAN STRIPPING AS WELL. THE EXTRACTOR/TREPHINE FROM THE AR-8738C SET WAS USED TO TRY AND REMOVE THE SCREW, BUT THE SCREW BROKE. THE PORTION OF THE BROKEN SCREW AND K-WIRE REMAINED IN THE PATIENT AS PART OF THE FINAL CONSTRUCT. A DYNANITE STAPLE WAS USED AS WELL TO PROVIDE FURTHER COMPRESSION. THE DOCTOR NOTED THAT THE PATIENT HAD VERY HARD BONE QUALITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18505873 ↗
• InjuryAug 18, 2023Break; Break

  ON (B)(6) 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

  Patient problems: Foreign Body In Patient

  MAUDE report 17572069 ↗
• InjuryOct 5, 2020Break

  IT WAS REPORTED, THAT DURING AN ANKLE FRACTURE REPAIR, THE SURGEON PREPPED THE BONE USING THE 2.7 DRILL, WITH K-WIRE AND PROFILE DRILL. WHEN INSERTING THE FIRST AR-8730-32H, COMPRESSION SCREW ON POWER, THE DRIVER TORQUED. THE SURGEON CONTINUED BY USING A HAND DRIVER TO ADVANCE THE SCREW BEFORE IT SNAPPED ABOUT 2/3 THE WAY IN. THE SURGEON WAS ABLE TO REMOVE THE SCREW USING VICE GRIPS. THE SURGEON CLEANED THE INSERTION SITE USING A 2.7 DRILL BIT AND PROFILE DRILL A SECOND TIME TO CREATE A CLEANER DRILL HOLE AND REMOVE ANY BONE DEBRIS. THE SURGEON THEN ATTEMPTED TO INSERT A SECOND AR-8730-32H COMPRESSION SCREW WITH THE HAND DRIVER AND THE SCREW SNAPPED OFF IN THE SAME LOCATION. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PART OF THE SCREW. THE CASE WAS COMPLETED WITH THE REDUCTION OF THE FRACTURE NOT AS EXPECTED. THE ISSUES EXTENDED THE PROCEDURE BY ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10631200 ↗
• InjuryFeb 19, 2019Break

  IT WAS REPORTED THAT DURING A 1ST MTP JOINT FUSION, THE SURGEON PERFORMED PER THE USUAL TECHNIQUE. THE BONE WAS PREPPED BY DRILLING WITH K-WIRE AND OVER-DRILL. THE K-WIRE AND DRILL WERE PART OF THE REQUIRED SET. WHILE INSERTING THE COMPRESSION SCREW, THE SCREW SHAFT SNAPPED LEAVING 2/3 OF THE SCREW IN THE BONE. THE HEAD PORTION OF THE SCREW WAS REMOVED FROM THE PATIENT AND THE CASE WAS COMPLETED BY INSERTING A SECOND SCREW IN A DIFFERENT DIRECTION. THE SURGEON WAS ABLE TO ACHIEVE JOINT COMPRESSION PRIOR TO PLATING.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8349714 ↗