Arthrex® AR-1570BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867018945), received between Jan 3, 2023 and Aug 27, 2026 — classified as 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Break

  On (b)(6) 2026, a distributor reported via email that an AR-1570BC BioComposite-Tenodesis Screw (7 x 23 mm) broke while being tightened after being placed in the joint. Another implant was used to complete the procedure. This was discovered during a tendon transfer procedure on (b)(6) 2026. No harm to the patient was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474251 ↗
• MalfunctionOct 23, 2025Break; Break

  ON 10/14/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-1570BC BIOCOMPOSITE TENODESIS SCREW BROKE DURING THE PASSAGE OF AN FHL ¿ ACHILLES TENDON TRANSFER. IT REMAINED LODGED WITH ONLY HALF ITS LENGTH AND HELD THE GRAFT IN PLACE. A REINFORCEMENT WAS APPLIED TO THE TENDON. THE SURGICAL TECHNICIAN REPORTED THAT THE TECHNIQUE WAS CORRECTLY PERFORMED AND THAT NO FRAGMENTS WERE LEFT BEHIND.

  Patient problems: Insufficient Information

  MAUDE report 23366400 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE. NO FURTHER INFORMATION WAS RECEIVED. UPDATE (B)(6) 27-AUG-25: MORE INFORMATION WAS PROVIDED. IT WAS REPORTED THAT DURING A RECONSTRUCTION SURGERY OF THE ACHILLES TENDON, THE SURGEON LOST GRIP DURING PLACEMENT OF THE SCREW. HE THEN CHECKED THE ANKLE AND SAW THAT THE SCREW WAS BROKEN. AFTER THAT HE TRIED TO RETRIEVE THE SCREW, BUT ONLY THE TOP CAME OFF, SO HE LEFT THE A PART IN THE PATIENT. THE BONE WAS QUITE SOFT SO IT¿S STRANGE THAT IT BROKE. THE SURGERY WAS FINISHED SUCCESSFULLY BY PLACING A SHORT SCREW ON TOP OF THE BROKEN SCREW. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 23015974 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A FLEXOR DIGITORUM LONGUS (FDL) TENDON TRANSFER, THE HEAD OF THE SCREW BROKE DURING INSERTION. THIS OCCURRED TWO TIMES DURING THE SURGERY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT 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 22148834 ↗
• MalfunctionApr 22, 2025Break; Break

  ON 4/10/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1570BC BIOCOMPOSITE-TENODESIS SCREW HAD AN ISSUE DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON PUT THE SCREW INSIDE THE PATIENT, THE TIP OF THE SCREW CRACKED UPON INSERTION. NO PART OF THE SCREW BROKE OFF INSIDE THE PATIENT, AND THE SCREW WAS REMOVED IN ONE PIECE FROM THE PATIENT WITH NO HARM. ANOTHER AR-1570BC BIOCOMPOSITE-TENODESIS SCREW WITH AN UNKNOWN LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. THERE WAS A SLIGHT CASE DELAY OF UNDER 5 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881571 ↗
• MalfunctionJan 3, 2023Break

  ON 12/14/22 IT WAS REPORTED BY A SALES REPRESENTATIVE BY EMAIL THAT A AR-1570BC BIOCOMPOSITE-TENODESIS SCREW BROKE WHEN PERFORMING A DUNK TECHNIQUE. THIS WAS DISCOVERED DURING AN ANTERIOR TIBIALIS TENDON TRANSFER TO THE LATERAL CUNEIFORM ON (B)(6) 2022. ALL PIECES OF THE BROKEN SCREW WERE RECOVERED. THE PROCEDURE WAS RESOLVED USING ANOTHER AR-1570BC SCREW WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086527 ↗