Arthrex® AR-3603-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867231320), received between May 24, 2018 and Jun 2, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR BANKART SURGERY THE TIP OF THE DEVICE BROKE WHEN BEING INSERTED WITH THE HAMMER ALTHOUGH THE SURGEON PRE-DRILLED AND USED A GUIDE. THE TIP COULD NOT BE REMOVED FROM THE PATIENT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22123368 ↗
• MalfunctionOct 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE THAT AN AR-3603-2, FIBERTAK¿ SUTURE ANCHOR, DOUBLE LOADED WITH #2 TIGERTAIL® (BLUE/BLACK AND WHITE/BLACK), ANCHOR IMPLANT FAILED DURING DEPLOYMENT. THIS WAS DETECTED AT AN UNSPECIFIED TIME ON (B)(6) 2024 WITH NO CASE INVOLVEMENT. FURTHER INFORMATION IS BEING REQUESTED FROM THE ARTHREX EMPLOYEE. (B)(6) 2024: IT WAS CLARIFIED BY THE ARTHREX EMPLOYEE THAT 2 UNITS OF AR-3603-2, FIBERTAK¿ SUTURE ANCHOR, DOUBLE LOADED WITH #2 TIGERTAIL® (BLUE/BLACK AND WHITE/BLACK), FAILED DURING DEPLOYMENT, THEY WERE DEPLOYED BUT THE ANCHOR PULLED OUT. THIS WAS DETECTED DURING A RIGHT SHOULDER SUBACROMIAL DECOMPRESSION, LABRAL REPAIR AND ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN AR-1934BCF-2 WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353588 ↗
• MalfunctionAug 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A BICEPS TENDON FIXATION SURGERY THE ANCHOR PULLED OUT. 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 20084671 ↗
• MalfunctionJun 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 6/16/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3603-2 FIBERTAK WAS ATTEMPTED TO BE IMPLANTED THREE TIMES AND IT WOULD NOT SEAT. THE FIRST TIME, WHEN SURGEON PULLED THE SUTURES TO CINCH DOWN, THE ANCHOR PULLED OUT. AFTER RELOADING THE ANCHOR AGAIN, THE SURGEON ATTEMPTED TO IMPLANT IT ONE MORE TIME, SAME THING HAPPENED, THE ANCHOR PULLED OUT. THE THIRD TIME, A NEW BONE SOCKET WAS CREATED AND THE ANCHOR WAS IMPLANTED, THIS TIME TOO, THE ANCHOR PULLED OUT. SURGEON COMPLETED CASE USING A DEVICE FROM ANOTHER MANUFACTURER ALONG WITH A KNOTLESS FIBERTAK. THIS WAS DISCOVERED DURING A BANKART REPAIR (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444341 ↗
• MalfunctionMay 15, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ANCHOR AR-3603-2 WOULD NOT SEAT. THE SITE HAD BEEN PRE-DRILLED BUT WOULD SEAT WHEN MALLETED. IT WAS REMOVED FROM THE PATIENT AND THE LABRAL REPAIR CASE WAS COMPLETED WITH SUTURETAKS. THERE WERE NO ADDITIONAL INCISIONS NEEDED. PATIENT 18 YEAR OLD MALE.

  Patient problems: Insufficient Information

  MAUDE report 19321643 ↗
• MalfunctionJan 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT AN AR-3603-2 FIBERTAK¿ SUTURE ANCHOR PULLED OUT. THIS OCCURRED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18614073 ↗
• MalfunctionApr 26, 2021Break

  IT WAS REPORTED THAT THREE DEVICES (AR-3603-2, LOT 12261340) BROKE DURING A SHOULDER ARTHROSCOPY SURGERY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725238 ↗
• InjuryAug 21, 2018Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A BANKART REPAIR PROCEDURE THE GLENOID WAS PREPPED WITH A 1.9 MM FLEX DRILL AND UPON INSERTION OF THE DOUBLE LOADED FIBERTAK WITH #2 TIGERTAIL, THERE WAS LAG AND WHEN THE SURGEON WENT TO PULL BACK ON THE DRILL GUIDE, IT BECAME NOTICED THAT THE INSERTER HAD BROKEN. THE INSERTER TIP IS LODGED INTO THE ANCHOR ITSELF AND REMAINED IN THE PATIENT. THE FRAGMENT WAS DEEP ENOUGH THAT THE SURGEON WAS UNABLE TO SEE IT OR REACH IT WITH A PROBE. HE THEN TIED THE SUTURE AND LABRUM DOWN OVER IT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7800664 ↗
• InjuryMay 24, 2018Break; Detachment Of Device Component

  THE SALES REP REPORTED THAT THE SMALL TWO PRONGED TIP ON THE FIBERTAK TIGERTAIL BROKE OFF WHEN INSERTING THE ANCHOR INTO THE DRILLED HOLE. THE BROKEN TIP REMAINS IN THE DRILL HOLE AFTER ANCHOR IMPLANTATION. THE SURGEON AND STAFF DECIDED NOT TO REMOVE THE BROKEN FRAGMENT FROM THE PATIENT. THE REP REPORTED THAT THE QUALITY OF THE BONE WAS HARD. FOLLOW-UP INVESTIGATION: THE INCIDENT OCCURRED DURING A MEDIAL COLLATERAL LIGAMENT REPAIR. AN X-RAY WAS NOT TAKEN TO LOCATE THE UN-RETRIEVED FRAGMENT. THE SURGEON BELIEVES THAT THE BROKEN TIP WILL STAY IN THE DRILL HOLE UNDERNEATH THE ANCHOR AND WILL NOT CAUSE ANY ISSUE OR PROBLEM FOR THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY USING THE SAME DEVICE AND WITHOUT INTERRUPTION. THE REP STATED THEY ARE PENDING CONFIRMATION FROM THE CUSTOMER IF THE DEVICE WILL BE RETURNED FOR EVALUATION. IT HAS BEEN CONFIRMED THAT THE SMALL TWO PRONGED TIP THAT REMAINED IN THE PATIENT IS THE TIP OF THE FIBER TAK INSERTER DEVICE AND NOT A PART OF THE FIBERTAK ANCHOR ITSELF. ADDITIONAL INFORMATION RECEIVED 5/7/18 VIA FACILITY MEDWATCH REPORT 220101-0000-2018-8013: PATIENT AGE WAS (B)(6). PATIENT IS NOT HISPANIC/LATINO.

  Patient problems: Foreign Body In Patient

  MAUDE report 7540114 ↗