Arthrex® AR-3710Recalls & reported problems
Arthrex, Inc. · Disposable Kit, Knee FiberTaks · Class 1
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867426016), received between Feb 5, 2024 and Aug 18, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated3
- Inadequacy of Device Shape and/or Size3
- Use of Device Problem2
- Break1
- Failure to Advance1
- Fitting Problem1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information4
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Failure to Advance
Patient problems: Insufficient Information
MAUDE report 50305844 ↗MalfunctionFeb 18, 2025Use of Device Problem; Use of Device Problem
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3710 DISPOSABLE DRILL GUIDE KIT AND (QTY. 2) OF AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR FAILED WHILE IMPLANTING USING THE DRILL GUIDE KIT. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 02/11/2025: THE AR-3710 DISPOSABLE DRILL GUIDE KIT DID NOT REMOVE ENOUGH BONE. IT DID NOT PRODUCE DEBRIS. THE (QTY. 2) OF AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR WOULD NOT INSERT INTO THE BONE AND WOULD JUST BEND WHEN BEING HAMMERED IN. NO INSTRUMENT OR IMPLANT BROKE DURING THIS ISSUE. THE CASE WAS COMPLETED USING A 4.75 SWIVELOCK MPFL KIT. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA. THERE WAS NO ADVERSE EFFECTS ON THE PATIENT REPORTED. THIS OCCURRED DURING A MPFL PROCEDURE ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21399530 ↗MalfunctionOct 11, 2024Material Fragmentation; Material Fragmentation
ON 10/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3710 DISPOSABLES KIT DRILL GUIDE WAS PRODUCING DEBRIS. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20428524 ↗MalfunctionOct 10, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE DRILL FROM AN AR-3710 KNEE FIBERTAK DISPOSABLE KIT BROKE DURING USE. THEN THE SURGEON ATTEMPTED TO SELF-PUNCH AN AR-3780SP SELF PUNCHING KNEE FIBERTAK BUTTON BIT IT ALSO BROKE DURING INSERTION. IT WAS REPORTED THE PATIENT HAD HARD BONE QUALITY. THE CASE WAS COMPLETED USING AN AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 10/4/2024: THE BROKEN FRAGMENT OF THE DRILL WAS LARGE ENOUGH TO FISH OUT OF THE SOCKET CREATED IN THE HUMERUS ALONG WITH ALL COMPONENTS OF THE FIBERTAK. THE CASE WAS DELAYED FIVE TO TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20417000 ↗MalfunctionSep 9, 2024Fitting Problem; Device Dislodged or Dislocated; Fitting Problem; Device Dislodged or Dislocated
ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3770SP HYBRID KNEE FIBERTAK WAS DIFFICULT TO MALLETED IN AND DID NOT FULLY SEAT. WHEN THE SURGEON ATTEMPTED TO SET THE ANCHOR, IT PULLED OUT. THE SURGEON WAS CONCERNED THAT THE PATIENT'S PATELLA WOULD BE FRACTURED WITH ANOTHER AR-3770SP HYBRID KNEE FIBERTAK, SO THE CASE WAS COMPLETED USING A 2.9 PUSHLOCK. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 8/26/2024: AN AR-3710 KNEE FIBERTAK DISPOSABLE KIT WAS USED TO PREPARE THE BONE SOCKET FOR THE INSERTION OF THE AR-3770SP HYBRID KNEE FIBERTAK. THE SURGEON FELT THE DRILL WAS INADEQUATE TO ACCOMMODATE THE PATELLAR BONE'S ANCHOR. A SECOND AR-3770SP HYBRID KNEE FIBERTAK WAS NOT USED; INSTEAD, THE SURGEON COMPLETED THE CASE WITH AN AR-1923PS PEEK PUSHLOCK. THE WAS DELAYED FOR FIVE MINUTES WITHOUT ADDITIONAL ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20169777 ↗MalfunctionMar 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 02/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3710 DISPOSABLE FIBERTAK ANCHOR PULLED OUT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. BOTH ANCHORS CAME OUT OF THE BONE WHILE THE SURGEON WAS TENSIONING THE LOOP SUTURE TO THE LIGAMENT. A SEPARATE DISPOSABLE KIT WAS UTILIZED FOR EACH ANCHOR DUE TO A DROP ON THE STERILE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18923116 ↗MalfunctionMar 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 02/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3710 DISPOSABLE FIBERTAK ANCHOR PULLED OUT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. BOTH ANCHORS CAME OUT OF THE BONE WHILE THE SURGEON WAS TENSIONING THE LOOP SUTURE TO THE LIGAMENT. A SEPARATE DISPOSABLE KIT WAS UTILIZED FOR EACH ANCHOR DUE TO A DROP ON THE STERILE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18923002 ↗MalfunctionFeb 6, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ON 1/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3710 KNEE FIBERTAKS DISPOSABLE KIT DOES NOT CREATE A BIG ENOUGH BONE HOLE FOR THE INSERTION OF THE DRILL GUIDE AND FIBERTAK. AFTER THE HOLE IS CREATED, THE SURGEON HAS DIFFICULTY IMPLANTING THE FIBERTAK TO THE POINT WHERE THE INSERTER OF THE FIBERTAK ENDS UP BROKEN OR WITH BENT PRONGS. THE BROKEN FRAGMENTS WERE CONTAINED WITHIN THE DRILL GUIDE, AND NOTHING WAS LOOSE INSIDE THE PATIENT. THE SURGEON HAS ATTEMPTED TO IMPLANT AN AR-3730SP DOUBLE LOADED KNEE FIBERTAK, AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK AND AN AR-3770SP HYBRID KNEE FIBERTAK, ALL WITH THE SAME RESULTS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2024.
Patient problems: Insufficient Information
MAUDE report 18652447 ↗MalfunctionFeb 6, 2024Inadequacy of Device Shape and/or Size; Use of Device Problem; Inadequacy of Device Shape and/or Size; Use of Device Problem
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3710 KNEE FIBERTAKS DISPOSABLE KIT DOES NOT CREATE A BIG ENOUGH BONE HOLE FOR THE INSERTION OF THE DRILL GUIDE AND FIBERTAK. AFTER THE HOLE IS CREATED, THE SURGEON HAS DIFFICULTY IMPLANTING THE FIBERTAK TO THE POINT WHERE THE INSERTER OF THE FIBERTAK ENDS UP BROKEN OR WITH BENT PRONGS. THE BROKEN FRAGMENTS WERE CONTAINED WITHIN THE DRILL GUIDE, AND NOTHING WAS LOOSE INSIDE THE PATIENT. THE SURGEON HAS ATTEMPTED TO IMPLANT AN AR-3730SP DOUBLE LOADED KNEE FIBERTAK, AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK AND AN AR-3770SP HYBRID KNEE FIBERTAK, ALL WITH THE SAME RESULTS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 18652268 ↗MalfunctionFeb 5, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3710 KNEE FIBERTAKS DISPOSABLE KIT DOES NOT CREATE A BIG ENOUGH BONE HOLE FOR THE INSERTION OF THE DRILL GUIDE AND FIBERTAK. AFTER THE HOLE IS CREATED, THE SURGEON HAS DIFFICULTY IMPLANTING THE FIBERTAK TO THE POINT WHERE THE INSERTER OF THE FIBERTAK ENDS UP BROKEN OR WITH BENT PRONGS. THE BROKEN FRAGMENTS WERE CONTAINED WITHIN THE DRILL GUIDE, AND NOTHING WAS LOOSE INSIDE THE PATIENT. THE SURGEON HAS ATTEMPTED TO IMPLANT AN AR-3730SP DOUBLE LOADED KNEE FIBERTAK, AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK AND AN AR-3770SP HYBRID KNEE FIBERTAK, ALL WITH THE SAME RESULTS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 18641951 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.