Arthrex® AR-8978-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867286801), received between Jul 28, 2020 and Sep 2, 2026 — classified as 7 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563658 ↗
• MalfunctionSep 2, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563522 ↗
• InjuryApr 6, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED A CYSTIC / ¿ALLERGIC-TYPE¿ REACTION AFTER A SCAPHOLUNATE RECONSTRUCTION PERFORMED WITH THE INTERNALBRACE SYSTEM.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24792878 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 11/11/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE FORK TIP OF A 3.5 SWIVELOCK FROM THE AR-8978-CP HAND/WRIST INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM DETACHED AND FELL TO THE FLOOR WITHOUT ANY PRIOR MANIPULATION. SUBSEQUENTLY, THE REMAINDER OF THE ANCHOR ALSO SEPARATED FROM THE INSERTER AND FELL TO THE FLOOR. NO HARM OCCURRED TO THE PATIENT. A NEW AR-8978-CP WAS OPENED TO COMPLETE THE PROCEDURE. THIS ISSUE WAS IDENTIFIED DURING A THUMB UCL REPAIR WITH INTERNAL BRACE PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 11/14/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707326 ↗
• MalfunctionOct 30, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8978-CP IMPLANT SYSTEMS (2) SWIVELOCKS BROKE. THIS OCCURRED DURING A THUMB RECONSTRUCTION ON (B)(6) 2025, WHEN THE SUTURES WERE BEING TIGHTENED, BOTH OF THE EYELETS BROKE OFF. THE PATIENT HAD A MEDIUM BONE QUALITY THAT WAS PREPPED USING THE DRILL IN THE KIT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE CONTINUED USING A SECOND AR-8978-CP IMPLANT SYSTEM. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426152 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY UPON IMPLANTATION, ONE OF THE TIPS OF THE BONE ANCHOR SNAPPED OFF PREMATURELY LEAVING THIS TIP IN THE BONE. THE SURGEON WAS UNABLE TO LOCATE AND REMOVE THIS TIP. THE TIP WAS LEFT IN SITU AND ANOTHER ANCHOR WAS IMPLANTED INTO THE SAME HOLE. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23393014 ↗
• MalfunctionJan 7, 2025Break; Break

  ON 12/10/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN AR-8978-CP IMPLANT SYSTEMS PLASTIC DRILL GUIDE SNAPPED AS THEY WERE USING IT. THIS OCCURRED DURING A CARPAL, METACARPAL PROCEDURE ON (B)(6) 2024 NO FRAGMENTS ENTERED THE PATIENT. THE CASE CONTINUED USING ANOTHER AR-8978-CP. THERE WAS NO PATIENT HARM. THEY DO NOT BELIEVE ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21094332 ↗
• MalfunctionOct 17, 2024Break; Break

  ON 10/4/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06679357 THAT THE KNOB OF THE SWIVELOCK FROM AN AR-8978-CP HAND/WRIST INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM KNOW WOULD NOT TWIST APPROPRIATELY. THE ANCHOR EVENTUALLY FLIPPED ON ITSELF UPON ENTRY. THE FORKED EYELET TIP BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 10/9/2024: THE FORKED EYELET BROKE BUT NOT INSIDE THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-8978-CP HAND/WRIST INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM. THE CASE WAS DELAYED ABOUT TWELVE MINUTES WITH NO ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474652 ↗
• MalfunctionApr 8, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A THUMB UCL RECONSTRUCTION SURGERY THE DEVICE WAS OPENED AND THE BLUE DRILL GUIDE WAS MISSING FROM THE IMPLANT SYSTEM. THE SURGEON DECIDED TO USE THE SET DESPITE MISSING DRILL GUIDE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067697 ↗
• MalfunctionMar 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 03/01/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8978-CP IMPLANT SYSTEM ANCHOR PULLED OUT. THIS OCCURRED DURING A CMC ARTHROPLASTY PROCEDURE ON (B)(6) 2024 WHEN THE SURGEON PLACED THE 3.5 SWIVELOCK FROM THE HAND AND WRIST INTERNAL BRACE KIT INTO THE 2ND METACARPAL, AND WHEN THEY TRIED TO REMOVE THE DRIVER IT WOULDN'T COME OUT. WHEN IT WAS FINALLY OUT THE ANCHOR PULLED OUT AND THE FORK TIP WAS LEFT IN THE TUNNEL. THE DRIVER SEEMED TO BE DEFECTIVE AND DID NOT RELEASE AS IT SHOULD HAVE. THE CASE WAS COMPLETED USING A CMC MINI TIGHTROPE.

  Patient problems: Insufficient Information

  MAUDE report 18923495 ↗
• MalfunctionMar 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 2/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT ONE OF THE SWIVELOCK ANCHORS FROM AN AR-8978-CP HAND/WRIST INTERNALBRACE IMPLANT SYSTEM PULLED OUT. THE SURGEON USED A SUTURE BUTTON AND TIED IT WITH THE OTHER SWIVELOCK FROM THE KIT, AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A CMC ARTHROPLASTY PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS DELAYED LESS THAN FIFTEEN MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 18884548 ↗
• MalfunctionFeb 8, 2024Crack; Crack

  ON 01/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8978-CP IMPLANT SYSTEM CRACKED. THIS OCCURRED DURING A CASE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669235 ↗
• MalfunctionJan 29, 2024Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  ON 1/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE EYELET OF THE SWIVELOCK'S FROM AN AR-8978-CP HAND/WRIST INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM AND FROM AN AR-8978P DX SWIVELOCK WOULD NOT UNTHREAD OR WOULD NOT BECOME UNSCREWED. THE SURGEON ATTEMPTED MULTIPLE TIMES WITHOUT SUCCESS. THE CASE WAS COMPLETED USING ANOTHER AR-8978-CP HAND/WRIST INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM AND FROM AN AR-8978P DX SWIVELOCK. THIS WAS DISCOVERED DURING A SCAPHOLUNATE LIGAMENT RECONSTRUCTION ON (B)(6) 2024. THE PATIENT WAS NOT AFFECTED, AND THE CASE WAS ONLY DELAYED TO OPEN THE NEW IMPLANTS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597281 ↗
• MalfunctionDec 7, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A SCAPHOLUNATE RECON SURGERY IT WAS FOUND THAT THE HAND AND WRIST DISPOSABLE KIT DID NOT CONTAIN A DRILL GUIDE WHEN IT WAS OPENED. AN ARTHREX REPRESENTATIVE WAS AT THE SURGERY AND SUPPORTED THE SURGEON. THE CUSTOMER THE USED THE CLEAR FUNNEL TO HOLD THE KEY WIRES. THE SURGEON MEASURED OUT THE DEPTH OF THE ANCHOR AND CUT THE TUBE WITH A SCALPEL TO FINISH THE SURGERY SUCCESSFULLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. UPDATE DW 13-NOV-2023. FURTHER INFORMATION WERE PROVIDED THAT THE PROCEDURE COULD BE CARRIED OUT EXACTLY LIKE IT SHOULD AND THAT NO ADDITIONAL SURGERY WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287521 ↗
• MalfunctionSep 26, 2023Failure to Advance; Failure to Advance

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE ANCHOR FROM AN AR-8978-CP HAND/WRIST INTERNALBRACE IMPLANT SYSTEM COULD NOT BE THREADED IN THE BONE. THIS WAS DISCOVERED DURING A CMC INTERNAL BRACE PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER ANCHOR. ADDITIONAL INFORMATION RECEIVED ON 9/11/2023: THE CASE WAS COMPLETED USING ANOTHER AR-8978-CP HAND/WRIST INTERNALBRACE IMPLANT SYSTEM; NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817346 ↗
• MalfunctionAug 31, 2023Component Missing; Component Missing

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8978-CP INTERNAL BRACE KIT WAS MISSING ONE OF THE 2.0 FIBERLOOP. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. DELAY IN PROCEDURE GREATER THAN 15 MINUTES. SURGEON BROUGHT IN X-RAY TO CHECK THAT THE MISSING NEEDLE WAS NOT LOST IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662180 ↗
• MalfunctionJul 14, 2023Component Missing; Component Missing

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT QTY. 2 OF AN AR-8978-CP IMPLANT SYSTEM HAD AN OUT-OF-BOX ISSUE. DURING A CNC ARTHROPLASTY PROCEDURE, WHEN THE SURGEON OPENED THE FIRST IMPLANT SYSTEM, THE FIBERLOOP SUTURES WERE MISSING OUT-OF-BOX. HE OPENED A SECOND IMPLANT SYSTEM WITH THE SAME LOT NUMBER, AND THAT WAS ALSO MISSING THE FIBERLOOP SUTURES. THE SURGEON THEN USED SUTURES OFF THE SHELVES, AN AR-7232-05 FIBERLOOP WITH A CURVED NEEDLE WITH AN UNKNOWN NUMBER, TO COMPLETE THE CASE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. PARTS OF THE IMPLANT SYSTEM REMAIN IN THE PATIENT, AND NO PICTURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17328516 ↗
• InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE PERFORMED ON THE RIGHT HAND, IN (B)(6) 2021. THE PATIENT IS POSSIBLY EXPERIENCING A REACTION TO MATERIAL(S) USED FOR THE REPAIR. THE PATIENT WILL BE SEEING AN ALLERGIST ON (B)(6) 2023, FOR SENSITIVITY TESTING. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16173397 ↗
• MalfunctionJul 25, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ANCHOR FROM AN AR-8978-CP HAND/WRIST INTERNAL BRACE KIT AND AN AR-8978P DX SWIVELOCK ANCHOR BROKE DURING INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 15092754 ↗
• InjuryJan 18, 2022Device Slipped

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8978-CP INTERNAL BRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM ANCHOR PULLED OUT. THIS WAS DISCOVERED DURING A CNC INTERNAL BRACE ON (B)(6) 2021. ONCE THE SURGEON INSERTED THE FIRST ANCHOR INTO THE PATIENT, THE SCREW BECAME STUCK TO THE INSERTER. THE SURGEON THEN USED A HAMMER TO TAP THE INSERTER TO REMOVE IT BUT INSTEAD THE SCREW PULLED OUT. THE BONE HOLE WAS THEN TOO LARGE TO USE ANOTHER AR-8978-CP, SO THE SURGEON THEN CREATED A NEW BONE HOLE, DISTAL TO THE PREVIOUS HOLE AND USED A AR-8919DS TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 13281816 ↗
• InjuryJan 11, 2022Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990ST-2 DX FIBERTAK WAS INSERTED THROUGH A 1.6MM PREPARED BONE TUNNEL AND AFTER IT PASSED THROUGH THE CORTEX, IT WAS DISCOVERED THAT THE FORKS ON THE INSERTER DEVICE HAD SHREDDED THE SUTURES BUNDLE. THIS WAS DISCOVERED DURING A REVISION OF A FAILED CMC INTERNAL BRACE ON (B)(6) 22021. SURGEON REDIRECTED TUNNELS AND USED A SINGLE-LOADED FIBERTAK DX TO COMPLETE PROCEDURE. ADDITIONAL INFORMATION RECEIVED 12/23/2021. THERE WERE NOT ARTHREX DEVICES EXPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13225998 ↗
• InjuryOct 12, 2021Device Slipped

  ON 09/23/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT WHEN THE SURGEON WAS DRILLING USING THE AR-8978-CP IMPLANT SYSTEM, HE NOTICED THAT THE KIT ONLY CONTAINED QTY.2 ON THE 3.5 DRILL BITS. THE SURGEON USED THE 3.5 DRILL BIT AND WHEN INSERTED THE IMPLANT ONTO THE PATIENT, THE IMPLANT PULLED OUT OF THE BONE AS IT HAD NO INTERFERENCE. THIS WAS DISCOVERED DURING USE IN A UCL INTERNAL BRACE PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING AN AR-1941PSV, 3.9 MM KNOTLESS CORKSCREW.

  Patient problems: Insufficient Information

  MAUDE report 12616680 ↗
• InjuryJan 5, 2021Patient-Device Incompatibility

  IT WAS REPORTED THROUGH THE ARTHREX WEBSITE THAT THE PATIENT HAS BEEN EXPERIENCING POSSIBLE ALLERGIC REACTIONS SINCE HAVING SURGERY USING AN ARTHREX INTERNAL BRACE FOR CMC. THE PATIENT HAS A TWO YEAR OLD SURGERY SCAR THAT IS ON THE SHOULDER/BICEP AREA THAT IS FEVERISH. IN ADDITION THE WRIST, TOP AND BOTTOM, ARE ALSO FEVERISH. PATIENT REPORTS A DESMOID TUMOR IN THE SAME BICEP. DOCTOR HAS PRESCRIBED CLINDAMYCIN TO TRY AND COMBAT THE ISSUE BUT THE MEDICATION MAKES THE PATIENT SICK TO HER STOMACH. SPECIFIC PART NUMBER OF IMPLANT(S) WAS NOT PROVIDED WITH INITIAL REPORT. ADDITIONAL INFORMATION OBTAINED 12/14/2020: THE PATIENT'S DATE OF LEFT HAND SURGERY WAS (B)(6) 2020. ARTHREX IMPLANT PART NUMBER WAS AR-8978-CP IMPLANT SYSTEM-HAND/WRITS INTERNAL BRACE (LOT 11759559). FIVE DAYS POST OP WHEN THE PATIENT WAS HAVING HER BANDAGES CHANGED OUT IT WAS DISCOVERED THAT HER LEFT THUMB AND HER BICEP SURGERY SCAR WERE BOTH FEVERISH AND RED. PATIENT REPORTS BEING IN EXCRUCIATING PAIN SINCE SURGERY. PATIENT ALSO HAS A DESMOID TUMOR IN HER LEFT BICEP. SHE WAS ORIGINALLY CONCERNED ABOUT IMPLANTING ANYTHING BECAUSE THE TUMOR HAD BEEN SHRINKING WITHOUT MEDICAL INTERVENTION. HER ONCOLOGY TEAM THOUGHT IT WO

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Pain; Skin Irritation

  MAUDE report 11116998 ↗
• InjuryJul 28, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO ONE OF THE DEVICES IMPLANTED IN A CASE ON HER RIGHT WRIST IN (B)(6) 2019 WHICH WAS DUE TO AN INJURY ROLLER SKATING ABOUT TWO YEARS AGO. USED DURING THE CASE WAS AR-1530PS, AR-8978-CP AND A K-WIRE, LOT # 0919343245 (NON-ARTHREX DEVICE). TWO WEEKS AFTER THE CASE, THE PATIENT RETURNED TO THE SURGEON WITH SWOLLEN FINGERS AND A BURNING SENSATION AT THE SITE. SHE IS ALLERGIC TO NICKEL; THE SURGEON WAS AWARE OF THIS PRIOR TO THE CASE BUT HAD THOUGHT THE K-WIRE WAS TITANIUM. WHEN SHE RETURNED. HE RECHECKED THE DEVICES USED AND FOUND THAT THE K-WIRE DID CONTAIN NICKEL; IT WAS THEN REMOVED FROM THE PATIENT. IT WAS ORIGINALLY SUPPOSED TO BE IN FOR EIGHT WEEKS TO IMMOBILIZE THE SITE AND WOULD HAVE BEEN REMOVED AFTER THAT. AFTER IT WAS REMOVED, THE PATIENT'S SYMPTOMS WERE REDUCED, BUT SHE STILL HAS MOBILITY PROBLEMS; SHE CANNOT CLOSE THE INDEX FINGER AND THE THUMB HURTS. PATIENT IS A (B)(6) FEMALE.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; Reaction; Swelling

  MAUDE report 10332236 ↗