Arthrex® AR-8827L-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867047051), received between Feb 13, 2018 and Mar 4, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Damaged Thread” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Patient Device Interaction Problem

  ON 21-OCT-2025, A HEALTH CARE PROFESSIONAL REPORTED VIA EMAIL THAT A CLAVICLE PLATE IMPLANTED IN A PATIENT EXPERIENCED A FAILURE. ACCORDING TO THE REPORT, THE FAILURE OCCURRED APPROXIMATELY SIX MONTHS POST IMPLANTATION, AND NO TRAUMA WAS NOTED DURING THAT PERIOD. RADIOGRAPHIC IMAGES OF THE PLATE FAILURE WERE PROVIDED FOR REVIEW. ADDITIONAL INFORMATION WAS RECEIVED ON 24-OCT-2025: THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2025, INVOLVING AN ORIF OF THE RIGHT CLAVICLE. THERE WERE NO INTRAOPERATIVE COMPLICATIONS, INCLUDING NO CASE DELAYS, ADDED ANESTHESIA TIME, OR ADVERSE EVENTS. THE SPECIFIC ARTHREX PART NUMBERS USED DURING THE PROCEDURE WERE NOT PROVIDED. THE IMPLANT FAILURE WAS IDENTIFIED SIX MONTHS POSTOPERATIVELY, OCCURRING AT THE JUNCTION BETWEEN THE SCREW HOLES. A REVISION SURGERY HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION REGARDING THE EVENT IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 10/30/2025: THE SPECIFIC ARTHREX PART NUMBERS USED DURING THE INITIAL PROCEDURE HAVE NOT BEEN PROVIDED AT THIS TIME. A REVISION SURGERY IS SCHEDULED TO TAKE PLACE IN TWO WEEKS. THE PATIENT DID NOT REPORT ANY PRIOR SYMPTOMS OR EXPERIENCE A POPPING SENSATION AT THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 24506295 ↗
• MalfunctionAug 12, 2025Damaged Thread; Damaged Thread

  IT WAS REPORTED DURING THE CLAVICLE FRACTURE PLATING SURGERY THAT THE SCREW STRIPPED WHEN FIXING IT IN THE PLATE AND THE UPPER THREAD OF THE SCREW DID NOT ENGAGE THE PLATE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782703 ↗
• MalfunctionAug 12, 2025Positioning Failure; Damaged Thread; Positioning Failure; Damaged Thread

  IT WAS REPORTED DURING THE CLAVICLE FRACTURE PLATING SURGERY THAT THE SCREW STRIPPED WHEN FIXING IT IN THE PLATE AND THE UPPER THREAD OF THE SCREW DID NOT ENGAGE THE PLATE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782656 ↗
• MalfunctionAug 12, 2025Positioning Failure; Damaged Thread; Positioning Failure; Damaged Thread

  IT WAS REPORTED DURING THE CLAVICLE FRACTURE PLATING SURGERY THAT THE SCREW STRIPPED WHEN FIXING IT IN THE PLATE AND THE UPPER THREAD OF THE SCREW DID NOT ENGAGE THE PLATE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782368 ↗
• MalfunctionJun 6, 2024Use of Device Problem; Use of Device Problem

  ON 1/13/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT QTY. 2 OF AN AR-8827L-14 LO-PRO LOCK SCREW HAD AN ISSUE. DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2023, WHEN THE SURGEON WAS TRYING TO LOCK THE SCREWS INTO THE PLATE, THEY KEPT SPINNING. BOTH SCREWS WERE REMOVED IN ONE PIECE, AND NOTHING BROKE INSIDE THE PATIENT. THE SURGEON USED THE BASEPLATE, MADE TWO HOLES NEXT TO THE ORIGINAL HOLES, AND USED TWO NON-LOCKING SCREWS AR-8827-14 LO-PRO SCREWS WITH UNKNOWN LOT NUMBERS INSTEAD. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THE COMPLAINT DEVICES WERE DISCARDED AND NO PICTURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478110 ↗
• InjuryMar 13, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED BY A PATIENT THAT SHE HAD UNDERGONE ANKLE SURGERY ON (B)(6) 2013 DURING WHICH TIME ARTHREX DEVICES WERE IMPLANTED. PATIENT MAY POSSIBLY BE HAVING AN ALLERGIC REACTION TO THE IMPLANT MATERIALS AND WAS INQUIRING ABOUT THE MATERIAL COMPOSITION. AT TIME OF INITIAL REPORT PATIENT DID NOT HAVE THE SPECIFIC PRODUCT NUMBERS OF HER IMPLANTS. PATIENT DOES NOT HAVE AN ALLERGY TO METAL BUT DOES HAVE ALLERGIES TO AT LEAST ONE COMPONENT OF TITANIUM, WHICH IS VANADIUM. ADDITIONAL INFORMATION OBTAINED 2/18/19: THE PROCEDURE ON (B)(6) 2013 WAS TO REPAIR AND ANKLE FRACTURE. THE PATIENT'S SYMPTOMS BEGAN SEVERAL MONTH AFTER SURGERY. THE AREA AROUND THE SURGICAL SITE BECAME SWOLLEN WITH SKIN DISCOLORATIONS AS WELL AS TEXTURE WHICH CONTINUE SEVERAL YEARS POST OP. PATIENT HAS FREQUENT FEELINGS OF STIFFNESS AND PRESSURE IN THE AREA AS WELL. PATIENT HAS BEEN TREATED WITH MOBIC (NON-STEROIDAL ANTI-INFLAMMATORY DRUGS). MATERIAL COMPOSITION OF THE IMPLANTED DEVICES, WHICH ARE COMPRISED OF STAINLESS STEEL AND MEET ASTM STANDARDS, HAS BEEN PROVIDED TO THE PATIENT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE (B)(6) 2013 PROCEDURE: AR-8943BR-06, LOCKING DISTAL FIBULA PLATE, RIGHT 6 HOLE (QTY 1

  Patient problems: Reaction; Skin Discoloration; Swelling

  MAUDE report 8417423 ↗
• InjuryJun 21, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A REVISION LT ANKLE FX PROCEDURE A TOTAL OF QTY. 3 AR-8827L-12 (LOT: 031731, LOT: 10158067, LOT: 185363) AND QTY. 2 AR-8827L-14 (LOT: 031725) WOULD NOT STAY ENGAGED IN THE PLATE. THE BONE WAS PREPPED BY A 2.0MM DRILL. ADDITIONAL INFORMATION RECEIVED 6/12/2018: THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2017. THE TYPE OF PROCEDURE BEING PERFORMED WAS A FIBULA FX. THE CASE TOOK PLACE AT (B)(6) HOSPITAL AND THE SURGERY WAS PERFORMED BY DR. (B)(6). THE FOLLOWING ARTHREX PART NUMBERS WERE IMPLANTED DURING THE (B)(6) 2017 PROCEDURE (LOT NUMBERS OF THE DEVICES ARE UNKNOWN). AR-8943BL-05; AR-8835-12 (QTY. 2); AR-8830-14 (QTY. 1); AR-8835-14 (QTY. 1); AR-8827L-14 (QTY. 3); AR-8827L-10 (QTY. 1). THE REVISION SURGERY TOOK PLACE ON (B)(6) 2018 TO FIX A HIGH NON UNION FIBULA FX. IT IS UNKNOWN IF OR WHAT SPECIFIC PART AND LOT NUMBERS WERE EXPLANTED DURING THE (B)(6) 2018 REVISION SURGERY. DURING THE REVISION SURGERY, A 2.7 LOCKING GUIDE WAS PLACED INTO THE LOCKING HOLE. THE BONE WAS DRILLED WITH A 2MM DRILL. A QUANTITY OF 3 AR-8827L-12, LOW PROFILE LOCKING SCREW(S) (LOT: 031731 // LOT: 10158067 // LOT: 185363) WOULD NOT FULLY ENGAGE INTO THE FIBULA PLATE. THE SURGEON B

  Patient problems: Failure of Implant

  MAUDE report 7625237 ↗
• InjuryFeb 13, 2018Fracture

  IT WAS REPORTED BY A FACILITY, WHO SENT A COPY OF A MEDWATCH (B)(4) WHICH THEY HAD FILED, THAT A PATIENT HAD ORIGINAL PLACEMENT OF HARDWARE THAT INCLUDED A PLATE AND SCREWS ON (B)(6) 2017 FOR A RIGHT DISPLACED LATERAL MALLEOLAR FRACTURE BY A HOSPITAL ORTHOPEDIC SURGEON. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2017 THE PATIENT WAS SEEN IN THE SURGEON'S OFFICE AND HAD COMPLAINTS OF INCREASING PAIN FOR THE PAST TWO MONTHS. THE PATIENT REPORTED TENDERNESS OVER PROMINENCE OF ONE OF THE SCREWS AS WELL AS THE ADDITIONAL AREA OF THE PLATE. THE SURGEON REVIEWED THE X-RAYS AND INDICATED NO CHANGE IN THE HARDWARE POSITION WITH NONE OF THE SCREWS BACKING OUT. ON (B)(6) 2017 THE PATIENT PRESENTED TO THE HOSPITAL WHERE THE ORTHOPEDIC SURGEON REPORTED THE FRACTURE AS HEALED BUT THE PATIENT REPORTED PAIN AND DYSFUNCTION WITH THE HARDWARE AND HAD WISHES FOR IT TO BE REMOVED. THE PATIENT HAD PLATE (AR-8943BR-04 LOCKING DISTAL FIBULA PLATE - (B)(4)) AND SCREW REMOVAL FROM HER RIGHT ANKLE UNDER GENERAL PLUS LOCAL ANESTHESIA. NO COMPLICATIONS WERE REPORTED. FOLLOW-UP INVESTIGATION: PER FACILITY MEDWATCH REPORTER, THE SURGEON'S OFFICE NOTES INDICATED THAT THERE WAS PAIN AND "PROMINENCE AT LOCKING SCRE

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 7266964 ↗