Arthrex® AR-3638DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00888867287440), received between Jan 27, 2020 and Jan 12, 2026 — classified as 6 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Physical Resistance/Sticking

  ON 22-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3638DS STRAIGHT KNOTLESS FIBERTAK DISPOABLE KIT DRILL BIT GOT STUCK IN THE GUIDE AS THERE WAS NO LUBRICATION AND IT WAS TOO DRY WITH NO WATER. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035840 ↗
• MalfunctionDec 26, 2025Failure to Advance; Failure to Advance

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-3638DS FIBERTAK DISPOSABLES STRAIGHT KITS DRILL WAS NOT ADVANCING INTO THE BONE. THE SURGEON HAD A HARD TIME GETTING THE DRILL STARTED AND FELT LIKE IT WAS NOT REMOVING ANY BONE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895532 ↗
• MalfunctionDec 26, 2025Failure to Advance; Failure to Advance

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-3638DS FIBERTAK DISPOSABLES STRAIGHT KITS DRILL WAS NOT ADVANCING INTO THE BONE. THE SURGEON HAD A HARD TIME GETTING THE DRILL STARTED AND FELT LIKE IT WAS NOT REMOVING ANY BONE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895472 ↗
• MalfunctionNov 26, 2025Break; Break

  ON 11/6/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3638DS KNOTLESS FIBERTAK DISPOSABLE KIT BOUND UP AND SNAPPED AT THE HUB NEAR THE DRILL DURING DRILLING. ADDITIONALLY, AN AR-3636 KNOTLESS 1.8 FIBERTAK PASSING SUTURE PULLED OUT OF THE ALL-SUTURE ANCHOR, WHICH APPEARED TO BE BROKEN. THE SURGEON WAS ABLE TO REMOVE ALL COMPONENTS FROM THE PATIENT. THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/13/2025: ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN AR-3610PK-3 PERCUTANEOUS INSERTION KIT FOR THE KNOTLESS FIBERTAK ANCHOR. A TWO-MINUTE DELAY OCCURRED WHILE OBTAINING THE REPLACEMENT KIT. NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 23656704 ↗
• MalfunctionMar 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 03/07/2025, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT (QTY. 2) OF AN AR-3638DS KNOTLESS FIBERTAK DISPOSABLE KIT HAD THE DRILL GET STUCK OR COLD WELDED IN THE DRILL GUIDE WHEN THEY WENT TO DRILL AND WOULD NOT ADVANCE DOWN THE GUIDE OR WOULD NOT COME OUT. THE DRILL ENDED UP BREAKING IN THE GUIDE. THEY OPENED A NEW KIT, AND THE SAME THING HAPPENED. THE DRILL WAS GETTING STUCK DOWN THE GUIDE. THEY COULD REMOVE THE DRILL FROM THE GUIDE, BUT IT WOULD NOT GO ALL THE WAY DOWN TO THE POSITIVE STOP. THEY NOTICED THAT TOWARDS THE START OF THE DRILL FLUTES, WHERE THE LOT NUMBER IS ON THE DRILL BIT, IT SEEMS LIKE IT¿S STARTING TO RUB AT THAT SPOT AND IS TAKING OFF THE NUMBERS. THE CASE WAS COMPLETED SUCCESSFULLY. NO REPORTED PIECES WERE BREAKING OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664376 ↗
• MalfunctionMar 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 03/07/2025, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT (QTY. (B)(4)) OF AN AR-3638DS KNOTLESS FIBERTAK DISPOSABLE KIT HAD THE DRILL GET STUCK OR COLD WELDED IN THE DRILL GUIDE WHEN THEY WENT TO DRILL AND WOULD NOT ADVANCE DOWN THE GUIDE OR WOULD NOT COME OUT. THE DRILL ENDED UP BREAKING IN THE GUIDE. THEY OPENED A NEW KIT, AND THE SAME THING HAPPENED. THE DRILL WAS GETTING STUCK DOWN THE GUIDE. THEY COULD REMOVE THE DRILL FROM THE GUIDE, BUT IT WOULD NOT GO ALL THE WAY DOWN TO THE POSITIVE STOP. THEY NOTICED THAT TOWARDS THE START OF THE DRILL FLUTES, WHERE THE LOT NUMBER IS ON THE DRILL BIT, IT SEEMS LIKE IT¿S STARTING TO RUB AT THAT SPOT AND IS TAKING OFF THE NUMBERS. THE CASE WAS COMPLETED SUCCESSFULLY. NO REPORTED PIECES WERE BREAKING OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664284 ↗
• MalfunctionJul 2, 2024Break; Break

  ON 05 JUNE 2024 IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-3638DS FIBERTAK DISPOSABLES STRAIGHT KIT HAD A DRILL BIT BREAK DURING USE. THIS OCCURRED ON (B)(6) 2024 DURING AN ARTHROSCOPIC POSTERIOR STABILIZATION IN (B)(6) PRIVATE HOSPITAL. THE DRILL WAS USED AS PER THE TECHNIQUE GUIDE. THE CASE WAS COMPLETED SUCCESSFULLY USING A NEW DRILL KIT. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19657667 ↗
• MalfunctionJun 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (QTY.2) AR-3638DS DISPOSABLE DRILL KITS WOULD HAVE STICK WHILE PULLING OUT AROUND HALFWAY OUT. BOTH KITS WERE DISCARDED AFTER THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484371 ↗
• MalfunctionJun 7, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE SURGEON WENT TO DRILL THE SOCKET FOR AN ANCHOR AND WHILE DRILLING THERE WAS A LOUD SOUND AS IF THE DRILL WAS RUBBING AGAINST THE GUIDE. THE DRILL DID SOME SPINNING AND WOULD NOT ADVANCE. THE SALES REP THAT WAS PRESENT ADVISED THE SURGEON TO PUT THE DRILL IN REVERSE TO BACK OUT AND ASSESS. WHEN THE SURGEON DID, THE DRILL AND THE GUIDE WERE ESSENTIALLY "FUSED" TOGETHER AND COULDN'T REMOVE THE DRILL FROM THE GUIDE. ANOTHER NEW KIT WAS OPENED AND CONTINUED WITH THE PROCEDURE WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484333 ↗
• MalfunctionJun 6, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED ON 09/19/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638DS FIBERTAK KITS DRILL BIT SHAFT SEIZED UP IN THE DRILL GUIDE AND BROKE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481370 ↗
• MalfunctionJun 1, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 02/18/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-3638DS FIBERTAK DISPOSABLES STRAIGHT KIT HAD AN ISSUE. THE DRILL WAS INSERTED THROUGH THE DRILL GUIDE. THE GUIDE AND DRILL FUSED TOGETHER AND COULD NOT BE REMOVED. IT OCCURRED TWICE DURING A PROCEDURE ON (B)(6) 2022. A NEW PRODUCT WAS USED AND THE CASE WAS COMPLETED WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444335 ↗
• MalfunctionMay 16, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A BANKART SURGERY THE DRILL COULD NOT BE GUIDED THROUGH THE DRILL SLEEVE, IT IS BLOCKED. DRILL SLEEVE NOT LARGE ENOUGH FOR THE ASSOCIATED DRILL. 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 19332329 ↗
• MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DRILL BIT SEIZED IN THE GUIDE DURING USE IN AN MPFL CASE. THEY USED ANOTHER AR-3638DS TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19318690 ↗
• MalfunctionApr 24, 2024Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE DRILL BIT SEIZED IN THE GUIDE DURING USE IN AN MPFL CASE. THEY USED ANOTHER AR-3638DS TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173837 ↗
• InjuryDec 11, 2023Break; Break

  ON 14TH NOVEMBER 2023, IT WAS REPORTED BY A SALES REP. VIA EMAIL THAT AN AR-3638DS, KNOTLESS FIBERTAK¿ DISPOABLE KIT, STRAIGHT, TIP OF THE DRILL BIT WAS SNAPPED OFF UPON COMPLETION OF DRILLING FOR A KNOTLESS FIBERTAK ANCHOR (AR-3636) IN THE GLENOID. THIS WAS DISCOVERED DURING USE IN A RIGHT SHOULDER LATERJET PROCEDURE AND CAPSULAR CLOSURE PROCEDURE ON (B)(6) 2023. THE PROCEDURE WAS COMPLETED USING A SECOND DISPOSABLE KIT WITHOUT DISRUPTION AND PATIENT HARM HOWEVER IT WAS NOT CONFIRMED IF THE BROKEN DRILL BIT WAS REMOVED FROM PATIENT. IT WAS THEN NOTED ON (B)(6) 2023, THAT THE PATIENT WILL BE RETURNED FOR SURGERY DATE(TO BE CONFIRMED) FOR ANCHOR AND DRILL BIT REMOVAL.X. 23/11/2023 - THE SALES REP. PROVIDED IMAGES OF THE NEEDLE OF AR-3638DS WHICH WAS REMOVED BY DR (B)(6) FROM THE PATIENT ON (B)(6) 2023 AT (B)(6) HOSPITAL. 27/11/2023 - ANOTHER SALES REP., (B)(4), HAD A CLOSER LOOK AT THE DRILL BIT AND BELIEVES THE SMALL JOINT COULD BE THE REASON FOR THE BREAKAGE. HE ASKED IF THERE COULD BE AN INVESTIGATION WITH INC WHY THIS WEAK POINT IN THE DRILL BIT EXISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307664 ↗
• MalfunctionDec 5, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE RIGID DRILL FROM AN AR-3638DS KNOTLESS FIBERTAK DISPOSABLE KIT BROKE INSIDE THE PATIENT. THE FRAGMENTS WERE NOT RETRIEVED, AND THE CASE CONTINUED USING ANOTHER AR-3638DS KNOTLESS FIBERTAK DISPOSABLE KIT FROM A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2023. THE CASE WAS NOT DELAYED, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18271024 ↗
• MalfunctionDec 1, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3638DS KNOTLESS FIBERTAK¿ DISPOSABLE KIT KEPT GETTING CAUGHT IN THE DRILL. THIS OCCURRED DURING A CASE WHEN DRILLING INTO THE BONE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18251204 ↗
• MalfunctionDec 1, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT (2) AR-3638DS KNOTLESS FIBERTAK¿ DISPOSABLE KITS KEPT GETTING CAUGHT IN THE DRILL. THIS OCCURRED DURING A CASE WHEN DRILLING INTO THE BONE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18251142 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY USING A 1.8 KNOTLESS FIBERTAK THE DRILL BROKE OFF INSIDE THE PATIENT. THE CUSTOMER REPORTED THAT THE SURGEON WAS UNABLE TO RETRIEVE THE FRAGMENT. HOWEVER THE SURGEON WAS CONFIDENT THAT THE DRILL TIP WAS IN THE BONE. 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.

  Patient problems: Foreign Body In Patient

  MAUDE report 18054562 ↗
• MalfunctionSep 29, 2023Break; Break

  ON 8/31/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06019604 THAT AN AR-3638DS FIBERTAK DISPOSABLES STRAIGHT KIT BROKE OFF DURING A PROCEDURE WITH NO FURTHER DETAILS. ALL FRAGMENTS WERE NOT RETRIEVED FROM THE PATIENT WITH NO FURTHER DELAY. THE CASE WAS COMPLETED WITHOUT ISSUES, AND NO ADDITIONAL INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 17843145 ↗
• MalfunctionSep 14, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 08/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3638DS DISPOSABLE KIT BECAME STUCK WHEN DRILLING. THIS OCCURRED DURING AN MPFL RECONSTRUCTION ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER KIT.

  Patient problems: Insufficient Information

  MAUDE report 17747578 ↗
• InjuryJun 9, 2023Break; Break

  ON 5/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3638DS FIBERTAK DISPOSABLES STRAIGHT KIT HAD AN ISSUE. DURING A LABRAL REPAIR PROCEDURE ON (B)(6)2023, WHEN THE DRILL WAS INSERTED THROUGH THE GUIDE, THEY WERE CYCLING IT AND CAME BACK OUT, AND THE DRILL GUN CAME OFF THE ACTUAL DRILL, IT WAS LOOSE. IT TORQUED THE DRILL AND BROKE THE TOP OF THE FLUTE INSIDE THE PATIENT'S GLENOID. THE ANCHOR WAS NEVER INSERTED. THE DRILL BIT COULD NOT BE REMOVED, AND THE SURGEON DEEMED IT SAFE TO LEAVE IT INSIDE THE GLENOID. X-RAYS WERE TAKEN AND WILL BE PROVIDED VIA EMAIL. THE DOCTOR USED A PUSHLOCK WITH AN UNKNOWN PART AND LOT NUMBER TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 5/24/2023, THE SALES REPRESENTATIVE STATED VIA PHONE THAT THE BROKEN DRILL HAD BEEN DISCARDED. ON 5/24/2023, THE SALES REPRESENTATIVE ALSO SENT A PICTURE OF AN X-RAY VIA EMAIL AND STATED THAT THE LOT NUMBER OF THE AR-3638DS FIBERTAK DISPOSABLES STRAIGHT KIT HAD NOT BEEN RECORDED. THE PROCEDURE WAS COMPLETED USING AN AR-2923BC SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK, WITH LOT NUMBER 15044351.

  Patient problems: Foreign Body In Patient

  MAUDE report 17097581 ↗
• MalfunctionMar 6, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3638DS KNOTLESS FIBERTAK¿ DISPOSABLE KITS DRILL BROKE. THIS OCCURRED DURING A SHOULDER ARTHROSCOPY LABRAL REPAIR ON (B)(6) 2023 WHEN THE DRILL BROKE OFF IN THE PATIENT'S GLENOID, A NEW KIT WAS IMMEDIATELY OPENED AND THE CASE WAS COMPLETED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16485051 ↗
• InjuryMar 6, 2023Break; Break

  ADDITIONAL INFORMATION PROVIDED ON 02/15/2023, IT WAS REPORTED THAT THE BROKEN DRILL BIT COULD NOT BE RETRIEVED. THE BROKEN FRAGMENT WAS BURIED IN THE GLENOID AND THE ONLY WAY TO GET IT OUT WOULD BE TO REMOVE HALF OF THE PATIENTS GLENOID.

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 16485035 ↗
• MalfunctionSep 26, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3636 IMPLANT FAILED NON-SPECIFICALLY AND AN AR-3638DS DRILL BIT BROKE DURING THE REPAIR. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15484243 ↗