Arthrex® AR-3632SP-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867341890), received between Apr 4, 2022 and Mar 13, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Positioning Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE ANCHOR DID NOT OPEN PROPERLY AND THEREFORE, THE DEVICE DID NOT GRIP. 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 24593849 ↗
• MalfunctionDec 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SURGERY TWO ANCHORS AR-3632SP-1 (LOT: 15459433) GOT CUT IN THE MIDDLE. 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 23815408 ↗
• MalfunctionDec 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SURGERY TWO ANCHORS AR-3632SP-1 (LOT: 15459433) GOT CUT IN THE MIDDLE. 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 23815337 ↗
• MalfunctionDec 1, 2025Positioning Failure; Positioning Failure

  ON 11 NOVEMBER 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3632SP-1, SP FIBERTAK RC DBLOAD TAPE BL/W BLK/W WAS REPORTED TO HAVE FAILED TO DEPLOY DURING USE. THIS OCCURRED ON (B)(6) 2025 DURING A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING A HARD BODIED ANCHOR. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23682221 ↗
• MalfunctionOct 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ***UPDATE, KHE, 28-OCT-2025. FURTHER INFORMATION RECEIVED WITH THE INCOMING DELIVERY DOCUMENT. IT WAS REPORTED THAT THE ANCHOR WAS TORN OUT DURING PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378757 ↗
• MalfunctionMay 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE ANCHOR BENT DURING INSERTION. 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 22045891 ↗
• MalfunctionMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LEMAIRE SURGERY THE ANCHOR TORE OUT. 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 22027153 ↗
• MalfunctionFeb 26, 2025Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR DIDN`T HOLD. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 21470341 ↗
• MalfunctionJan 3, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SELF-PUNSH DID NOT WORK AND THE ANCHOR COULD NOT BE RELEASED FROM THE DRIVER. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069410 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER RECONSTRUCTION THE TIP OF THE HANDLE BROKE WHILE PUNCHING IT. THE SURGEON WAS ABLE TO RETRIEVE THE PART OUT OF THE PATIENT. THE SURGEON REPORTED THAT 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. 21-DEC-2021 DW UPDATE. FURTHER INFORMATION WAS PROVIDED THAT THE TIP OF THE SHAFT WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566181 ↗
• MalfunctionJun 13, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A DOUBLE ROW RM SUTURE AFTER THE TWO IMPLANTS WERE APPLIED THEY COULD BE PULLED OUT. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM A DIFFERENT MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527460 ↗
• MalfunctionMay 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS THAT DURING A ROTATOR CUFF SURGERY WHILE SUTURING THE LIGAMENT, THE ANCHOR WAS PULLED OUT OF THE BONE. 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 19400794 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A TENODESIS SURGERY WHEN THE SURGEON TIED THE KNOT AND WANTED TO TIGHTEN IT, THE SUTURETAPE OF THE DEVICE BROKE. THE DEVICE REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (CORKSCREW SUTURETAPE). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249055 ↗
• MalfunctionOct 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR DID NOT HOLD. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY BY INSERTING A SWIVELOCK. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 11-OCT-2023 NROE: FURTHER INFORMATION WAS PROVIDED AND REVEALED THAT THE FIBERTAK BENT WHILE BEING INSERTED INTO THE BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958799 ↗
• MalfunctionFeb 13, 2023Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE IMPLANT AND THE SUTURE BROKE. 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16361779 ↗
• MalfunctionApr 4, 2022Activation Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THERE WAS NO BLOCKAGE IN THE BONE WITH THE DEVICE. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 15-MAR-2022: IT WAS CONFIRMED THAT AFTER INSERTING THE FIBERTAK SELF-PUNCHING ANCHOR AND REMOVING THE ANCHOR GUIDE, THE SURGEON, IN ORDER TO CHECK WHETHER THE ANCHOR IS SITTING ¿ANCHORED¿, PULLED THE STRAPS AS ALWAYS AND UNFORTUNATELY THE ANCHOR FELL OUT OF THE BONE. A SECOND DEVICE WAS USED IN THE SAME PLACE AND THIS TIME THE ANCHOR HAS "ANCHORED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994806 ↗