Arthrex® AR-3630-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867276871), received between Apr 26, 2024 and Dec 9, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionDec 9, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A KNEE COLATERAL RECONSTRUCTION + ANTERIOR CRUCIATE LIGAMENT SURGERY THE TWO ANCHORS AR-3632SP (LOT: 15436729) AND AR-3630-1 (LOT: 15327535) WHERE INSERTED TO THE TIBIA AND DIDN'T HOLD. ANOTHER ANCHOR WAS INSERTED INSTEAD (AR-3632SP) THAT DID HOLD IN THE BONE AND THE SURGERY ENDED WELL WITH NO DAMGE TO THE PATIENT. 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 23758089 ↗
• MalfunctionNov 27, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SHOULDER ARTHROSCOPY A SEAM OF THE DEVICE FELL OFF THE ANCHOR. 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 20797791 ↗
• MalfunctionSep 20, 2024Break; Break

  ON 12 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3630-1 FIBERTAK, DOUBLOAD FW BL/W, BLK/W WAS REPORTED TO HAVE SNAPPED DURING USE. THIS OCCURRED ON (B)(6) 2024 ON (B)(6) HOSPITAL DURING A ROTATOR CUFF REPAIR. IT WAS REPORTED THAT THE FIBERTAK ANCHOR WAS IMPLANTED AND WHEN SURGEON PASSED ONE LIMB OF THE SUTURE, IT SNAPPED OFF CLOSE TO THE MID PART OF THE SUTURE. NOTHING SHARP CAME IN CONTACT WITH ANY POINT OF SUTURE. THE CASE WAS COMPLETED SUCCESSFULLY USING EXTRA FIBERWIRE. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20268959 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY THE ANCHOR CAME OUT WHEN PULLING ON THE SUTURE. WHEN THE SURGEON TRIED TO REPLACE THE DEVICE, HE NOTICED THAT THE DEVICE WAS BROKEN. A X-RAY WAS USED TO FIND THE MISSING PART. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE CORKSCREW AR-1927BCF TO FIXATE THE SUTURE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181496 ↗
• MalfunctionJun 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A LABRUM REFIX SURGERY THE ANCHOR COULD NOT BE RELEASED. 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 19494680 ↗
• MalfunctionMay 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN RM SUTURE WHILE INSERTING THE ANCHOR, THE ANCHOR BACKED OUT OF THE BONE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH A DIFFERENT PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 30-JUL-2021 DW UPDATE: FURTHER INFORMATION WERE PROVIDED THAT NO ADDITIONAL HOLE WAS NEEDED. THE SURGEON USED THE SAME HOLE WITH THE NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267157 ↗
• MalfunctionApr 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROXIMAL BICEP TENODESIS SURGERY THE FIBERWIRE SUTURE FROM THE DEVICE UNRAVELED WHEN TOUCHED AND MANIUPLUATED WITH THE SIXTER AND RHINO SUTURE RETRIEVED. 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.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19191475 ↗
• MalfunctionApr 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROXIMAL BICEP TENODESIS SURGERY THE FIBERWIRE SUTURE FROM THE DEVICE UNRAVELED WHEN TOUCHED AND MANIUPLUATED WITH THE SIXTER AND RHINO SUTURE RETRIEVED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19191380 ↗