Arthrex® AR-8978P-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867287105), received between Mar 1, 2019 and May 5, 2025 — classified as 2 injuries, 6 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 16, 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.

• MalfunctionMay 5, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE DEVICE DID NOT GRIP AND FELL OUT. 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 21963387 ↗
• MalfunctionApr 9, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY ONE ELEMENT CAME LOOSE WHILE THE IMPLANT WAS SCREWED IN AND THEREFORE THE SUTURE COULD NOT BE TIGHTENED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071416 ↗
• MalfunctionJul 25, 2022Break; Crack

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION SURGERY WHEN INSERTING THE DEVICES, THE IMPLANTS CRACKED AND A PART OF THE DEVICES BROKE OFF. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 15093432 ↗
• MalfunctionJul 11, 2022Break

  IT WAS REPORTED THAT DURING A DORSAL SCAPHOLUNATE RECONSTRUCTION PROCEDURE FOR TENDON AND FIBERTAPE FIXATION THE ANCHOR OF THE DEVICE BROKE BETWEEN ANCHOR THREADED PART AND FORKED TIP. THE TIP BROKE OF AT THE STAGE WHEN SURGEON COULD NOT INSERT THE THREADED PART IN THE BONE AND DUE TO THAT TOOK THE ANCHOR OUT. THE FORKED TIP COULD NO LONGER BE SCREWS ON AND THE AFFECTED ANCHOR WAS NOT USED. ALL BROKE PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 14976431 ↗
• InjuryJun 13, 2022Break

  3 ANCHORS BROKE UPON INSERTION AND INCORRECT ADVICE DURING USE. THERE WAS A 30 MINUTES DELAY TO THE SCAPHOLUNATE LIGAMENT RECONSTRUCTION PROCEDURE. ADDITIONAL ANESTHESIA IS REQUIRED PATIENT OUTCOME WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675323 ↗
• MalfunctionSep 28, 2021Break

  IT WAS REPORTED THAT THE FORK OF THE DEVICE AR-8978P-1 (LOT 11857988) BROKE DURING IMPLANTATION. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE ON 13-SEP-2021: IT WAS CONFIRMED THAT THE AR-8978P-1 DEVICE WAS USED FIRST AND WHEN IT BROKE, THE AR-1530BC DEVICE WAS INSERTED INTO THE SAME BONE TUNNEL, WHICH ALSO BROKE. ALL FRAGMENTS OF THE AR-8978P-1 WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540281 ↗
• MalfunctionFeb 15, 2021Break

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE BROKE OFF WHEN IMPLANTING THE SCREW BUT THE SALES REP STATED THAT NOTHING BROKE OFF INSIDE PATIENT. NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY WAS 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 11328091 ↗
• InjuryMar 1, 2019Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SCAPHOLUNARY LIGAMENT RECONSTRUCTION ON (B)(6) 2017 DUE TO A SCAPHOLUNAR DISSOCIATION. THE SURGERY WAS PERFORMED WITH AN ARTHREX RECONSTRUCTION SET (INTERNAL BRACE) AUGMENTED WITH ECRL TENDON STRIPS, TRANSFIXATION WITH K-WIRE. THE PATIENT HAD GOOD JOINT CARTILAGE CONDITIONS AT THIS TIME. AFTER THE FIRST SURGERY, THE PATIENT SUFFERED FROM PERSISTENT DISCOMFORT AND RENEWED DISSOCIATION AS WELL AS THE DEVELOPMENT OF LARGE LYSIS ZONES IN THE AREA OF THE SCREW ANCHORAGE OF THE LIGAMENT RECONSTRUCTION. IN A CT PERFORMED ON THE PATIENT, ONLY A RADIOULNAR PARTIALLY INTACT JOINT SPACE WAS VISIBLE. THE DOCTOR DECIDED TO PERFORM A REVISION SURGERY ON (B)(6) 2019. WHEN THE ANCHORS WERE REMOVED, ONE WAS BROKEN AND THE OTHER WAS LOOSE, CAUSING THEM TO GRIND AND DAMAGE THE CARTILAGE IN THE RADIOCARPAL JOINT. THE TAPE SHOWED ITSELF PROMINENTLY IN THE JOINT. THE PATIENT RECEIVED A WRIST STIFFENING DUE TO THE INCIDENT BECAUSE THE CARTILAGE AND BONE WERE SO SERIOUSLY DESTROYED THAT A JOINT-PRESERVING INTERVENTION WITH PARTIAL ARTHRODESIS WAS NO LONGER POSSIBLE. DUE TO THE ARTHRODESIS OF THE WRIST, THE PATIENT CAN NO LONGER MOVE THE WRIST.

  Patient problems: Discomfort

  MAUDE report 8381688 ↗