Arthrex® AR-8827L-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867047068), received between Jun 27, 2019 and Mar 4, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Damaged Thread” (1 report).

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 4 most recent of 4 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 24506285 ↗
• 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 22782625 ↗
• MalfunctionMay 7, 2024Failure to Advance; Failure to Advance

  ON 9/21/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 8827L-16 LOCKING SCREW WOULD NOT LOCK IN THE DISTAL HOLES OF THE PLATE. THIS WAS FOUND DURING A PROCEDURE. SURGEON COMPLETED CASE BY USING A NEW SCREW. ADDITIONAL INFO RECEIVED 9/21/2021 THIS WAS DISCOVERED DURING A CLAVICLE FRACTURE PROCEDURE AND THE NEW SCREW USED TO COMPLETE THE CASE WAS ANOTHER 8827L-16 LOCKING SCREW

  Patient problems: Insufficient Information

  MAUDE report 19265874 ↗
• InjuryJun 27, 2019Appropriate Device Problem Term/Code Not Available; Inaccurate Information

  IT WAS REPORTED DURING A PRIMARY PERCUTANEOUS PROCEDURE THAT TOOK PLACE ON (B)(6) 2019, THE SURGEON WAS ATTEMPTING TO PUT A SONOMA 3.5 X 55 ((B)(4)/ LOT: A17111705 ) SCREW INTO THE AR-8973L-30-130 FIBULA NAIL (LOT: 10297815), BUT THE SCREW WOULD NOT LINE UP AND THE SURGEON COULD NOT GET THE RIGHT TRAJECTORY. THE SURGEON WAS ABLE TO ACHIEVE GOOD FIXATION WITHOUT USING THE SCREW. THE FIBULA NAIL WAS LEFT IMPLANTED, AND THE CASE WAS COMPLETED SUCCESSFULLY. THE PATIENT CAME IN FOR A FOLLOW UP VISIT ON (B)(6) 2019 AND DURING THE FOLLOW-UP VISIT IT WAS DISCOVERED THAT THE PATIENT AMBULATED ON THE NAIL POST-OPERATIVELY AND RE-FRACTURED THEIR FIBULA. A REVISION/REMOVAL PROCEDURE TOOK PLACE ON (B)(6) 2019, AND WAS PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY. DURING THE REVISION PROCEDURE, THE AR-8973L-30-130 WAS SUCCESSFULLY REMOVED. UPON REMOVAL, IT WAS DISCOVERED THAT THE DEVICE IS LABELED AS AN AR-8973L-30-130 (LEFT) NAIL, BUT THE DEVICE IS ACTUALLY A RIGHT NAIL. THE NAIL WAS REINSERTED ON THE JIG, AND UPON FURTHER INVESTIGATION ALL HOLES LINED UP AS A RIGHT NAIL. IT WAS ALSO DISCOVERED THAT THE LOT NUMBER ETCHED ON THE DEVICE IS DIFFERENT THAN THE LOT NUMBER THAT WAS ON THE ORIGI

  Patient problems: Bone Fracture(s)

  MAUDE report 8739499 ↗