Arthrex® AR-1678-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00888867020887), received between Aug 23, 2016 and Aug 26, 2026 — classified as 14 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Physical Resistance/Sticking

  Patient problems: Insufficient Information

  MAUDE report 50454154 ↗
• MalfunctionFeb 16, 2026Failure to Advance

  ON 28-JAN-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THE ANCHOR FROM AN AR-1678-CP INTERNALBRACE LIGAMENT AUGMENTATION REPAIR KIT COULD NOT BE INSERTED INTO THE BONE. THE PAD WAS HELD APPROPRIATELY, AND THE SCREWDRIVER WAS TURNED, BUT THE ANCHOR WOULD NOT ADVANCE. THE BONE QUALITY WAS DESCRIBED AS HARD. NO FRAGMENTS WERE RETAINED IN THE PATIENT. THE OCCURRENCE OCCURRED DURING A LISFRANC LIGAMENT RECONSTRUCTION PERFORMED ON (B)(6) 2026. THE CASE WAS COMPLETED USING A REPLACEMENT AR-1678-CP KIT. THERE WAS NO SIGNIFICANT SURGICAL DELAY, NO ADDITIONAL ANESTHESIA WAS REQUIRED, AND NO ADVERSE EFFECTS WERE REPORTED. NO PATIENT HARM WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344217 ↗
• MalfunctionOct 29, 2025Material Fragmentation; Material Fragmentation

  ON 10/20/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN ISSUE OCCURRED WITH THE AR-1678-CP INTERNALBRACE LIGAMENT AUGMENTATION REPAIR KIT DURING A PROCEDURE. WHILE DRILLING INTO THE FIBULA USING THE 2.7 MM HOLLOW DRILL THROUGH THE DRILL GUIDE, A METAL FRAGMENT-LIKE OBJECT WAS FOUND ATTACHED TO THE DRILL. THE SURGEON INSPECTED THE DRILL GUIDE BUT FOUND NO FOREIGN MATERIAL PRESENT. NO FRAGMENTS WERE REPORTED TO BE RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-1678-CP KIT. NO DETAILED INFORMATION WAS PROVIDED REGARDING THE TYPE OF SURGERY. THERE WAS NO SIGNIFICANT DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO ADVERSE EFFECTS REPORTED. ADDITIONALLY, NO PHOTOGRAPHS WERE TAKEN OF THE EVENT. THE ISSUE WAS IDENTIFIED DURING A PROCEDURE ON (B)(6) 2025, WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415132 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A LATERAL ANKLE STABILISATION SURGERY THE 4.75 SWIVELOK ANCHOR BROKE ON INSERTION. 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 20158894 ↗
• MalfunctionJul 8, 2024Melted; Melted

  ON 06/11/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA E-MAIL THAT AN AR-1678-CP IMPLANT SYSTEMS PLASTIC SLEEVE BEGAN TO MELT DUE TO HEAT. THIS OCCURRED DURING A CASE WHILE DRILLING WITH A 2.7MM DRILL, THE PLASTIC SLEEVE BEGAN TO MELT DUE TO HEAT. THIS CASE WAS COMPLETED AS IS WITH NO REPLACEMENTS. NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 6/18/2024: NO ONE WAS HURT DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688642 ↗
• MalfunctionJun 10, 2024Environmental Particulates; Environmental Particulates

  ON 5/13/2024 IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA E-MAIL THAT AN AR-1678-CP IMPLANT SYSTEM WAS PRODUCING ION DUST WHEN DRILLING. THIS OCCURRED OUTSIDE THE PATIENT DURING AN INTERNAL BRACE PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497196 ↗
• MalfunctionJun 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 5/1/2023 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT THE DRILL AND DRILL GUIDE FROM AN AR-1678-CP INTERNALBRACE IMPLANT SYSTEM GOT STUCK. THE CASE WAS COMPLETED USING ANOTHER AR-1678-CP INTERNALBRACE IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 5/2/2023: THIS WAS DISCOVERED DURING AN ANTERIOR TALOFIBULAR LIGAMENT REPAIR PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19493170 ↗
• MalfunctionApr 17, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 3/15/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1678-CP IMPLANT SYSTEM, INTERNALBRACE LIGAMENT AUGMENTATION REPAIR HAD THE 4.75MM SWIVELOCK ANCHOR IS NOT DISASSOCIATED FROM THE SHAFT. NO PIECES BROKE INSIDE THE PATIENT, AND THE CASE WAS COMPLETED USING ANOTHER AR-1678-CP IMPLANT SYSTEM FROM AN UNKNOWN LOT. THIS WAS DISCOVERED DURING AN MBO WITH INTERNALBRACE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 3/19/224: THE CASE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127291 ↗
• MalfunctionFeb 9, 2024Break; Break

  ON 1/24/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-1678-CP INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM PEEK ANCHOR BROKE WHILE BEING INSERTED. THE REPORT WAS NEGATIVE FOR A FOREIGN BODY, AND THE CASE WAS FINISHED WITHOUT FURTHER INCIDENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. NO FURTHER INFORMATION WAS REPORTED.ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18676745 ↗
• MalfunctionJan 24, 2024

  DURING THE PROCEDURE, A PEEK ANCHOR BROKE WHILE BEING INSERTED. REPORT WAS NEGATIVE FOR FOREIGN BODY AND CASE WAS FINISHED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570544 ↗
• MalfunctionAug 31, 2023Break; Break

  ON 08/03/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1678-CP IMPLANT SYSTEM SCREW BROKE RIGHT AFTER INSERTING IT INTO THE PATIENT. THIS WAS DISCOVERED DURING AN ELBOW INTERNAL BRACE. THE CASE WAS COMPLETED BY USING A NEW AR-1678-CP.

  Patient problems: Insufficient Information

  MAUDE report 17662421 ↗
• MalfunctionAug 25, 2023Break; Break

  ADDITIONAL INFORMATION: THE ANCHOR BROKE INSIDE THE PATIENT, AND ALL FRAGMENTS WERE REMOVED. THE ANCHOR WAS PART OF THE AR-1678-CP IMPLANT SYSTEM. A 3.4MM DRILL BIT AND A 4.75MM SWIVELOCK TAP WERE USED TO PREPARE THE BONE SOCKET FOR IMPLANT INSERTION. IT WAS A YOUNG PATIENT WITH HARD BONE QUALITY. THERE WAS A CASE DELAY OF 20-30 MINUTES. SPINAL ANESTHESIA WAS USED, BUT ADDITIONAL ANESTHESIA DOSES WEREN¿T ADMINISTERED DURING THE CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624868 ↗
• MalfunctionAug 24, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A ATFL REPAIR SURGERY WITH INTERNAL BRACE, AFTER TAPPING THE TALUS WITH THE 4.74MM TAP, THE SURGEON ATTEMPTED TO ADVANCE THE SUTURE LOADED 4.75MM SWIVELOCK BIO-COMPOSITE SCREW INTO THE TALUS. THE SCREW DID NOT ADVANCE AND CAUSED THE GREEN PLASTIC SHEATH TO WRAP OVER THE TOP OF THE SCREW. A SEPARATE AR-2324BCC WAS OPENED TO COMPLETE THE SURGERY. UPON INSPECTION OF THE FAULTY ANCHOR POST-OP, THEY WERE STILL UNABLE TO MOVE THE SCREW FROM THE DRIVER TIP. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610408 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE TIP OF THE WORKING INSTRUMENT BROKE OFF INTRAOPERATIVELY, NOTHING WAS RETAINED. 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 17033127 ↗
• InjuryMay 10, 2023Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1678-CP INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM WAS USED IN AN ATFL PROCEDURE ON (B)(6) 2023. POSTOPERATIVELY, THE PATIENT EXPERIENCED AN ALLERGIC REACTION, POSSIBLY LEADING TO AN INFECTION. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023, IN WHICH THE IMPLANTS WERE REMOVED, AND THE AFFECTED AREAS WERE WASHED. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 16905855 ↗
• MalfunctionApr 17, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-1678-CP IMPLANT SYSTEMS DRILLS TIP SNAPPED AT THE TIP INTO A COUPLE OF PIECES. THIS OCCURRED DURING A RIGHT ANKLE INTERNAL BRACE WHEN ATTEMPTING TO DRILL WITH THE 3.4 CANNULATED DRILL USING THE PIN AS A GUIDE WHEN THE TIP OF THE DRILL SNAPPED INTO A COUPLE OF PIECES. THE FRAGMENTS WERE SUCCESSFULLY RETRIEVED, AND THE CASE WAS COMPLETED USING THE NON-CANNULATED 3.4 DRILL. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751394 ↗
• MalfunctionDec 5, 2022Break; Manufacturing, Packaging or Shipping Problem; Mechanical Jam

  IT WAS REPORTED THAT AN ANKLE INSTABILITY SURGERY WAS PERFORMED. FIRST OF ALL, THE 4.75 MM BC SWIVELOCK ANCHOR HAD NO SCREW. THEN THEY TRIED TO PLACE THE 3.5 MM SWIVELOCK BUT THE ANCHOR WAS POORLY LOADED AND IT DIDN'T TURN. SO THEY WEREN'T ABLE TO SCREW IT CORRECTLY INTO THE BONE. WHEN THEY TRIED TO REMOVE THE SCREW IT BROKE. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 15914169 ↗
• MalfunctionJul 5, 2022Material Separation; Component Missing

  ON 6/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN EYELET AND SUTURES FROM AN (B)(4) INTERNAL BRACE IMPLANT SYSTEM, CAME OFF THE SCREW, AND THE SCREW WAS LOST IN THE PATIENTS BODY. SURGEON SPENT ABOUT 90 MINUTES SEARCHING FOR THE SCREW UNDER DIRECT VISION AND COULD NOT LOCATE IT. ANOTHER AR-1678-CP INTERNAL BRACE IMPLANT SYSTEM WAS OPENED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A FLAT FOOT CORRECTION SPRING LIGAMENT INTERNAL BRACE PROCEDURE ON (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 14914543 ↗
• MalfunctionJan 31, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1678-CP INTERNAL BRACE IMPLANT SYSTEM 3.5 SWIVELOCK SCREW HAD BEEN BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13397866 ↗
• MalfunctionNov 15, 2021Break; Entrapment of Device

  ON 10/29/2021, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA E-MAIL THAT WHILE THE SURGEON WAS USING AN AR-1678-CP IMPLANT SYSTEM, AND INSERTED THE SCREW INTO THE BONE HOLE CREATED IN THE FIBULA, IT WAS FOUND THAT THE TIP OF THE SCREWDRIVER WAS BROKEN AND THE BROKEN PIECE FELL OFF AND REMAINED IN THE PATIENT'S BODY. THE SURGEON TRIED TO REMOVE THE BROKEN PIECE, BUT IT COULD NOT BE REMOVED, AND THE PIECE STILL REMAINS IN THE PATIENT'S BODY. THIS WAS DISCOVERED DURING USE IN A LATERAL LIGAMENT OF THE FOOT ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-1678-CP.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12814675 ↗
• MalfunctionAug 24, 2021Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE SURGEON INSERTED THE AR-1678-CP, THE 3.5MM SWIVEL WOULD NOT INSERT. UPON CONFIRMATION, THE OUTER CYLINDER WAS TORN EVEN THOUGH THE SCREW WAS NOT BROKEN. THE CASE WAS COMPLETED BY USING A NEW AR-1678-CP. NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 12362119 ↗
• MalfunctionJun 8, 2021Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANKLE LIGAMENT RECONSTRUCTION SURGERY THE INTRODUCER TIP BROKE ON INSERTION OF SCREW FROM THE IMPLANT. IT WAS FURTHER REPORTED BY THE SURGEON THAT THE TIP REMAINED INSIDE THE PATIENT BUT IT IS NOT EXPECTED TO CAUSE ANY SHORT OF LONG TERM PROBLEMS TO THE PATIENT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11956462 ↗
• InjuryOct 19, 2020Break

  IT WAS REPORTED IN MAILED IN MEDWATCH THAT THE FOLLOWING INCIDENT (MW5096382) HAD BEEN REPORTED TO THE FDA: "PATIENT WAS UNDERGOING A SCHEDULED RIGHT ANKLE LIGAMENTOUS RECONSTRUCTION WITH ARTHREX ANCHORS AND INTERNAL BRACE, AR-1678-CP. INTRA-OP, THE IMPLANT BROKE WHILE BEING INSERTED. AN 0.8MM PIECE REMAINS ON THE IMPLANT, APPROXIMATELY, 0.8MM PIECE INSERTED INTO THE BONE BY THE SURGEON. THE SURGEON AND THE ARTHREX EQUIPMENT ARE AWARE AND ARE IN AGREEMENT THAT THE IMPLANT IS SUFFICIENT AS IS. DISCUSSED WITH THE SURGEON WHO REPORTED THAT THE LENGTH OF THE IMPLANT WAS SUFFICIENT FOR ANCHORING. NO PATIENT HARM. PATIENT DISCHARGED TO HOME SAME DAY AS PLANNED." THE MEDWATCH REPORT DOES NOT CONTAIN FACILITY OR REPORTER INFORMATION. THEREFORE NO FOLLOW IS POSSIBLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10698188 ↗
• InjuryJul 7, 2020Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANTERIOR TALOFIBULAR LIGAMENT REPAIR AND AUGMENTATION A 3.5MM SWIVELOCK ANCHOR WAS INSERTED. WHILE THE ANCHOR WAS PUSHED INTO THE BONE THE INSERTER BECAME BENT AFTER FORCE WAS APPLIED. ONCE THE HANDLE WAS ENGAGED THE ANCHOR SCREWED IN BUT THE TOP PORTION OF THE ANCHOR SNAPPED OFF ON THE HANDLE. THE SURGEON DECIDED THAT THE CONSTRUCT IS STRONG AND STABLE ENOUGH AND FINISHED THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10240599 ↗
• InjuryFeb 26, 2020Material Fragmentation

  IT WAS REPORTED THAT USING INTERNAL BRACE FOR LATERAL ANKLE REPAIR. THE 1.35MM K-WIRE WAS INSERTED INTO THE TALUS, AND THE 2.7MM CANNULATED DRILL WAS USED OVER THE K-WIRE. AS THE SURGEON STARTED DRILLING INTO THE BONE, THE DRILL BIT FRACTURED INTO MULTIPLE PIECES. FRAGMENTS HAD TO RETRIEVED FROM THE PATIENT. SURGERY CONTINUED WITH THE OTHER DRILL BITS AND SWIVELOCK ANCHORS, AND THE END RESULT WAS FINE, WITH NO HARM TO THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE SOLID 2.7MM DRILL IN THE INTERNAL BRACE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ON 14-FEB-2020 (B)(6): THE END USER REPORTED THIS INCIDENT TO THE (B)(6) AUTHORITY - (B)(6). THE END USER STATED THAT WHILE DRILLING OVER A PREVIOUSLY INSERTED K-WIRE, THE CANNULATED DRILL SHATTERED IN THE PATIENTS BONE BENDING THE K-WIRE AND LEAVING SHRAPNEL IN THE BONE. THE K-WIRE WAS REMOVED AND THE SURGEON TOOK AN X-RAY OF THE PATIENTS ANKLE. IT WAS FOUND THAT MOST OF THE METAL FRAGMENTS WERE REMOVED BUT SOME WERE TOO DEEP TO REMOVE WITHOUT CAUSING FURTHER TRAUMA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9756832 ↗