Arthrex® AR-8916VSL-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867130999), received between Dec 27, 2017 and Jul 9, 2024 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ON 6/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT DISTAL 2.4 SCREWS WERE GOING THROUGH AN AR-8916VSL-03 VOLAR DISTAL RADIUS PLATE DURING INSERTION. THE PLATE WAS SWAPPED FOR A NEW AR-8916VSL-03 VOLAR DISTAL RADIUS PLATE, BUT THE SCREWS WERE STILL GOING THROUGH THE PLATE. THE ISSUE OCCURRED EVEN THOUGH THE SURGEON USED A TORQUE LIMITER DRIVER TO INSERT THE SCREW. THIS WAS DISCOVERED DURING A DISTAL RADIUS PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 6/24/2024: THE CASE WAS COMPLETED BY USING A NEW PLATE AND SCREWS. THE CASE WAS DELAYED THIRTY MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 19701619 ↗
• MalfunctionJul 9, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT DISTAL 2.4 SCREWS WERE GOING THROUGH AN AR-8916VSL-03 VOLAR DISTAL RADIUS PLATE DURING INSERTION. THE PLATE WAS SWAPPED FOR A NEW AR-8916VSL-03 VOLAR DISTAL RADIUS PLATE, BUT THE SCREWS WERE STILL GOING THROUGH THE PLATE. THE ISSUE OCCURRED EVEN THOUGH THE SURGEON USED A TORQUE LIMITER DRIVER TO INSERT THE SCREW. THIS WAS DISCOVERED DURING A DISTAL RADIUS PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 6/24/2024: THE CASE WAS COMPLETED BY USING A NEW PLATE AND SCREWS. THE CASE WAS DELAYED THIRTY MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 19701540 ↗
• MalfunctionJun 17, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A DISTAL RADIUS FRACTURE REPAIR PROCEDURE, AS THE SURGEON WAS INSERTING THE AR-8724-22 2.4MM SCREW INTO THE AR-8916VSL-03, VOLAR DISTAL RADIUS PLATE, AS THE SURGEON WAS COMPLETING THE FINAL TIGHTENING, THE SCREW HEAD WENT STRAIGHT THROUGH. THE SURGEON REMOVED THE PLATE AND SCREW. THE CASE WAS COMPLETED USING A DIFFERENT AR-8916VSL-03, LOT: 0290944 AND AR-8724V-20, 2.4MM LOCKING SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547045 ↗
• MalfunctionJun 12, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A VOLAR DISTAL PROCEDURE, THE SCREWS DID NOT FIT INTO THE PLATE AR-8916VSL-03 HOLES. THE CASE WAS COMPLETED BY USING AN NEW AR-8916VSL-03 WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525311 ↗
• MalfunctionJun 7, 2024Damaged Thread; Damaged Thread

  ON 1/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8916VSL-03 VOLAR DISTAL RADIUS PLATE WOULD NOT CATCH THE THREADS OF THE LOCKING SCREW. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19485752 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT THE AR-8916CX24-24 SCREW WENT THROUGH THE PLATE AR-8916VSL-03 DURING IMPLANT FOR A DISTAL RADIUS FRACTURE. THE IMPLANTATION STARTED ON POWER; THE SURGEON WAS USING HAND CONTROL AT THE LAST PART WHICH IS WHEN THE SCREW BROKE THROUGH THE PLATE. ANOTHER SCREW AND PLATE WERE USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446137 ↗
• MalfunctionMay 13, 2024Use of Device Problem; Use of Device Problem

  ON 4/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8724-24 LOW PROFILE SCREW, 2.4 MM X 24 MM, WENT STRAIGHT THROUGH AN AR-8916VSL-03 VOLAR DISTAL RADIUS PLATE. ANOTHER SCREW WAS ATTEMPTED, AND THE SAME THING HAPPENED; IT WENT STRAIGHT THROUGH THE PLATE. FINALLY, ANOTHER PLATE WAS USED, AND THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 4/27/2023: THE AR-8916VSL-03 VOLAR DISTAL RADIUS PLATE COULD NOT GET ANY OF THE SCREWS TO LOCK. THE SURGEON USED THE SAME SCREW ON A NEW PLATE WHICH WORKED SUCCESSFULLY. THE CASE WAS COMPLETED WITH ANOTHER AR-8916VSL-03 AR-8916VSL-03. THIS WAS DISCOVERED DURING A DISTAL RADIUS ORIF PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19299378 ↗
• MalfunctionMay 7, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE THE SURGEON HAD AN ISSUE WITH A VOLAR DISTAL RADIUS PLATE. THE DISTAL 2.4 LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE AND JUST SPUN IN PLACE. THE SURGEON THEN TOOK OUT THE PLATE, REPLACED WITH ANOTHER PLATE, AND DID NOT WANT TO USE ANY OF THE SCREWS FROM THIS SET. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257681 ↗
• MalfunctionFeb 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A COMPLEX HWR OF SPANNING PLATE AND ORIF DISTAL RADIUS, POSSIBLE ARTHREX PLATE, POSSIBLE WRIST EX-FIX, ORIF DRUJ, TRICEPS REVISION/REPAIR PROCEDURE, THE PLATE WAS REMOVED AND REDUCTION OF THE FRACTURE WAS PERFORMED. WHEN MANIPULATING THE FRACTURE, THE SURGEON MENTIONED THAT THE BONE WAS SUBPAR AND X-RAYS SHOWED THE SAME. HE ASKED TO USE THE ARTHREX DRP SET; IT WAS OPENED AND HE CHOSE TO USE THE STANDARD LEFT 3-HOLE PLATE, AR-8916VSL-03. HE INSERTED A 3.5 CORTICAL SCREWS IN THE OBLONG HOLE AND DIDN'T LIKE THE FIT, SO HE TOOK IT OUT AND BENT THE PLATE. INSERTED A 3.5 SCREW BACK INTO THE OBLONG HOLE AND LIKED THE FIT MUCH BETTER. HE ASKED FOR THE LOCKING TOWER, THEN ABOUT VARIABLE ANGLE, SO WE GAVE HIM THE VAL GUIDE AND REP TOLD HIM HE HAD A 20 DEGREE CONE. HE DRILLED, MEASURED AND INSERTED A 20MM 2.4 VAL, AR-8724V-20, SCREW IN THE CENTRAL-MEDIAL HOLE. REP DIDN'T HAVE DIRECT VISUALIZATION BUT SAW HIM BACK THE SCREW OUT, OR TRY TO, AND THEN ASKED WHY OUR DRIVER TIPS ARE BLUNT. THE REP GAVE HIM THE OTHER TIP FROM THE SET AND HE STRIPPED THE SCREW. HE PULLED THE THE 3.5 SCREW OUT, PULLED THE PLATE OUT AND SAID THE 2.4 WENT THROUGH THE PLATE. HE THEN ASKED FOR

  Patient problems: Insufficient Information

  MAUDE report 18684574 ↗
• MalfunctionOct 9, 2023Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 2.4MM VAL SCREW BIT THREW AN AR-8916VSL-03 VOLAR DISTAL RADIUS PLATE DURING INSERTION. THE PLATE WAS REMOVED, AND NOTHING BROKE INSIDE THE PATIENT. NO EXTRA BONE SOCKETS WERE CREATED, AND THE PATIENT HAD AN ADEQUATE BONE QUALITY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17899188 ↗
• MalfunctionSep 7, 2023Fitting Problem; Fitting Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8916VSL-03 VOLAR DISTAL RADIUS PLATE HOLES APPEARED TO BE LARGER THAN THE DISTAL HOLES. WHEN THE SURGEON ATTEMPTED TO LOCK A 2.4MM SCREW, IT PUSHED PAST THE HOLES, UNABLE TO BE LOCKED. THIS WAS DISCOVERED DURING A DISTAL RADIUS ORIF PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 17699945 ↗
• InjuryDec 10, 2019Positioning Failure

  IT WAS REPORTED BY THE SALES REP, THAT DURING A DISTAL RADIUS FRACTURE REPAIR, THE SURGEON IMPLANTED AN AR-8919VSL-03, VOLAR DISTAL RADIUS PLATE AND 3 SCREWS, AS THE SURGEON WAS PLACING THE LAST TWO LOCKING SCREWS AR-8724V-20, THE SCREWS WENT COMPLETELY THROUGH THE VOLAR PLATE. THE SURGEON THEN REMOVED ALL FIVE SCREWS AND PLATE, CAUSING A 30 MINUTE DELAY IN SURGERY. ADDITIONAL ANESTHESIA NEEDED TO BE ADMINISTERED TO THE PATIENT FOR THE DELAY. THE SURGEON COMPLETED THE CASE USING A DIFFERENT AR-8724VSL-20, VOLAR PLATE AND FIVE NEW AR-8724V-20, SCREWS WITHOUT FURTHER DELAYS OR COMPLICATIONS. ADDITIONAL INFORMATION OBTAINED 11/25/2019: THE SALES REP HAS REVIEWED THE ORIGINAL EVENT DESCRIPTION AND HAS PROVIDED AN UPDATED DESCRIPTION WITH CORRECTED PART NUMBERS: IT WAS REPORTED BY THE SALES REP, THAT DURING A DISTAL RADIUS FRACTURE REPAIR, THE SURGEON IMPLANTED AN AR-8916VSL-03 (LOT 10307271), VOLAR DISTAL RADIUS PLATE. THE SURGEON PLACED ALL FIVE OF THE SCREWS INTO THE PLACE BUT NOTICED THAT THE TWO DISTAL SCREWS, AR-8724V-20, HAD PASSED ALL THE WAY THROUGH THE LOCKING HOLES ONTO THE PATIENTS RADIUS BONE. THEY HAD ATTEMPTED TO ENGAGE THE SCREW WITH THE DRIVER AND REVERSE THEM THROUGH T

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9443999 ↗
• InjuryMar 7, 2018Bent; Crack; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL PROCEDURE WAS PERFORMED (B)(6) 2018. CASE: DISTAL RADIUS. EVERYTHING WENT WELL WITH THE ORIGINAL SURGERY TO THE BEST OF THE SURGEON'S KNOWLEDGE. ON (B)(6) 2018, PATIENT HAD A REVISION BECAUSE THE PLATE CRACKED OR BENT AND THE ONE OF MORE SCREWS WERE BACKING OUT. SURGEON WAS GOING TO GO BACK IN AND TIGHTEN THEM DOWN, HOWEVER, UPON SCREWING THEM BACK IN; THE SCREWS WERE NOT HOLDING. THE SURGEON ENDED UP HAVING TO REPLACE THE RIGHT SIDED PLATE AND FOUR SCREWS. FOLLOW UP INFORMATION: AFTER A PATIENT FALL 4 OF THE DISTAL SCREWS BACKED OUT OF THE PLATE RESULTING IN SURGEON NEED TO PERFORM A REVISION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7321369 ↗
• InjuryDec 27, 2017Bent; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2017 WHERE A VOLAR DISTAL RADIUS PLATE (AR-8916VSL-03) WAS IMPLANTED ALONG WITH 5 CORTEX SCREWS. THE PATIENT AFTER INITIAL IMPLANTATION RETURNED HOME AND REPORTS NO FURTHER ISSUES UNTIL FOLLOW UP WITH THE SURGEON. ON (B)(6) 2017, A REVISION WAS PERFORMED TO EXPLANT THE VOLAR DISTAL RADIUS PLATE AND ALL 5 CORTEX SCREWS AS DURING THE PATIENT'S POST-OP APPOINTMENT, THE SURGEON FOUND THAT ALL 5 SCREWS WERE BENT AND HAD BACKED OUT OF THEIR RESPECTIVE LOCKING HOLES IN THE DISTAL RADIUS PLATE. THE SURGEON REPORTS THAT PATIENT HAD NO FALLS, EARLY RANGE OF MOTION OR OTHER EVENT THAT COULD HAVE OCCURRED THAT WOULD'VE CAUSED THIS ISSUE, HOWEVER HE BELIEVES THAT THE PATIENT COULD HAVE EXPERIENCED A FALL OR SOME TYPE OF EVENT THAT CAUSED THIS FAILURE TO OCCUR BUT THE PATIENT DOES NOT RELIABLY GIVE A HISTORY OF SUCH. PATIENT IS A FEMALE, (B)(6). THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: AR-8916VNC-14, LOT: 151596 / (B)(4); AR-8916VNC-16, LOT: 95141729 / (B)(4); AR-8916VNC-18, LOT: 95241731 / (B)(4); AR-8935-12, LOT: 10150458 / (B)(4); AR-8935-14, LOT: 10158950 / (B)(4) AND AR-8916

  Patient problems: Bone Fracture(s)

  MAUDE report 7147525 ↗