Arthrex® AR-3600DRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867239128), received between Jan 12, 2018 and Jul 17, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE WIRE AND DRILL GUIDE GOT COLD WELDED. 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 22535307 ↗
• MalfunctionJun 4, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ON 05/15/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3600D-3 DRILL WAS INSERTED INTO THE AR-3600D AND STARTED DRILLING, IT GOT STUCK IN THE MIDDLE AND WHEN TRIED TO FORCE IT OUT, THE DRILL BROKE. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER. NO PATIENT HARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144849 ↗
• MalfunctionJun 17, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON THE 14TH FEBRUARY 2023 IT WAS ADVISED VIA EMAIL THAT AN AR-3600D, (DISPOSABLES KIT, FOR FIBERTAK¿ SUTURE ANCHOR WITH 1.6 MM DRILL, STRAIGHT SPEAR AND OBTURATOR) - (BATCH#14950285) WAS CLOGGED UP AND JAMMED UPON DRILLING INTO THE GLENOID. THE GUIDE HAS A SMALL WINDOW THAT APPEARS TO BE CLOGGED UP WITH BONE. THE PROCEDURE WAS COMPLETED BY USING A 3.0MM SUTURETAK OVER THE EXISTING HOLE. A CASE AND PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547410 ↗
• MalfunctionJun 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 1/19/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3600D DISPOSABLE KIT FOR FIBERTAK. DURING A CASE, AS THE SURGEON LOADED THE DRILL INTO THE CORRESPONDING DRILL SLEEVE AND BEGIN TO DRILL, THE DRILL BIT GOT BOUND UP INSIDE THE SLEEVE, LOCKING THE DRILL INTO THE SLEEVE. NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19500070 ↗
• MalfunctionJun 4, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE DRILL BOUND UP AND SEIZED IN DRILL GUIDE DURING DRILLING PROCESS AND WAS UNABLE TO REMOVE FROM DRILL GUIDE REQUIRING OPENING OF A NEW DRILL GUIDE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463645 ↗
• MalfunctionJun 1, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER STABILISATION / LATERGET SURGERY DURING THE INITIAL PREPERATION FOR INSERTION OF THE ANCHOR, THE DRILL BIT WAS STUCK IN THE DRILL GUIDE AND COULD NOT BE REMOVED. THE FIRST ANCHOR INSERTION SITE COULD BE PREPARED BUT NO SUBSEQUENT ANCHORS COULD BE USED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441987 ↗
• MalfunctionMar 1, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR LABRUM REPAIR SURGERY THE DRILL BIT BROKE OFF IN THE GLENOID BONE INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A BIGGER DRILL (1.8MM). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816993 ↗
• MalfunctionJan 5, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 12/11/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-3600D DISPOSABLES KIT FOR FIBERTAK SUTURE ANCHOR WITH 1.6 MM DRILL, STRAIGHT SPEAR, AND OBTURATOR HAD AN ISSUE. WHEN DRILLING INTO THE BONE, THE BONE SHAVINGS WOULD GET STUCK IN THE DRILL HANDLE, AND THEN THE DRILL WOULD BE COLD-WELDED IN THE GUIDE. NOTHING BROKE INSIDE THE PATIENT, AND THERE WAS NO REPORTED CASE DELAY. THE CASE WAS COMPLETED USING ANOTHER AR-3600D FROM THE SAME LOT WITHOUT THE DRILL BIT. INSTEAD, AN AR-3610NSD-2 FLEXIBLE 1.8MM SHAVERDRILL FOR FIBERTAK SOFT ANCHOR WITH FLEXIBLE OBTURATOR WAS USED AS THE DRILL. THIS WAS DISCOVERED DURING A SHOULDER BICEPS TENDINITIS PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18458590 ↗
• MalfunctionDec 28, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 11/30/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT THE DRILL FROM AN AR-3600D FIBERTAK DISPOSABLES KIT DID NOT GO INTO THE GUIDE PROPERLY. THE GUIDE MIGHT HAVE BEEN BENT. THE CASE WAS COMPLETED USING ANOTHER PRODUCT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 12/6/2023: THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE, AND IT WAS COMPLETED USING A NEW AR-3600D FIBERTAK DISPOSABLES KIT.

  Patient problems: Insufficient Information

  MAUDE report 18409862 ↗
• MalfunctionJun 23, 2023Break; Break

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE DRILL BIT FROM AN AR-3600D DISPOSABLES KIT FOR FIBERTAK BROKE OFF INSIDE THE PATIENT AND IT REMAINS IN THE BONE. THIS WAS DISCOVERED DURING A PROXIMAL HAMSTRING REPAIR PROCEDURE ON (B)(6)2023.

  Patient problems: Foreign Body In Patient

  MAUDE report 17190158 ↗
• InjuryJan 15, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED VIA FACILITY MEDWATCH COPY (REPORT NUMBER NOT SHOWN) THAT A PATIENT HAD ARTHROSCOPIC ROTATOR CUFF REPAIR WITH BICEPS TENODESIS ON (B)(6) 2018. FOLLOW-UP X-RAY REVEALED THE TIP OF THE DRILL BIT HAD BROKEN OFF AND WAS LYING NEXT TO THE TERES MAJORE. X-RAY WAS TAKEN ON (B)(6) 2018. REMOVAL OF DRILL BIT TIP WAS PERFORMED ON (B)(6) 2018. ADDITIONAL INFORMATION OBTAINED 12/26/18: FACILITY HAS CONFIRMED THAT THEY HAVE RETAINED THE DEVICE AND WILL NOT BE RELEASING IT AT THIS TIME. FACILITY HAS PROVIDED PICTURES OF THE DRILL BIT TO ARTHREX.

  Patient problems: Foreign Body In Patient

  MAUDE report 8247755 ↗
• InjuryJan 12, 2018Material Fragmentation

  IT WAS REPORTED THAT DURING A BRISTOW BANKART PROCEDURE UNDER ARTHROSCOPY, A SURGEON DRILLED A BONE HOLE AND ATTEMPTED TO INSERT THE ANCHOR, BUT THE ANCHOR STOPPED IN THE MIDDLE OF THE BONE HOLE. HE DRILLED THE BONE HOLE AGAIN AND NOTICED THAT THE TIP OF THE DRILL WAS DAMAGED. THE TIP OF THE DRILL REMAINED IN THE BONE HOLE. THE BROKEN TIP REMAINED IN THE PATIENT. FOLLOW-UP INVESTIGATION THE REPORTED CONFIRMED THAT THE DRILL TIP REMAINED IN THE BONE HOLE/TUNNEL. REPORTER HAS NO ADDITIONAL INFORMATION WITH REGARD TO WHETHER AN ANCHOR WAS LATER PLACED IN THE TUNNEL, THUS SECURING THE DRILL TIP OR NOT. REPORTER ALSO HAD NO ADDITIONAL INFORMATION WITH REGARD TO HOW THE PROCEDURE WAS COMPLETED AFTER THE DRILL TIP BROKE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7185385 ↗