Arthrex® AR-3730SPRecalls & reported problems
Arthrex, Inc. · Dbl Loaded Knee FiberTak, w/ Needles · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867431645), received between Oct 13, 2023 and Aug 21, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
- Device Dislodged or Dislocated6
- Material Twisted/Bent5
- Activation Failure1
- Failure to Advance1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions7
- Failure of Implant2
- Foreign Body In Patient2
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2026Break
Patient problems: Foreign Body In Patient
MAUDE report 50373129 ↗MalfunctionMay 14, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING THE LEFT KNEE QUADRICEPS TENDON REPAIR, THE ANCHOR DID NOT DEPLOY AND SEAT PROPERLY, SO IT PULLED OUT INSTANTLY. EVEN RELOADING THE ANCHOR AND TRYING AGAIN DIDN'T HELP, AND THE ANCHOR PULLED OUT AGAIN. 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 25171272 ↗MalfunctionDec 29, 2025Break; Break
ON 12/08/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3730SP DOUBLE LOADED KNEE FIBERTAK® ANCHOR EXPERIENCED A FAILURE WHEN ONE OF THE FORK TIPS BROKE OFF DURING AN OPEN SHOULDER PROCEDURE. THE PATIENT HAD AVERAGE BONE QUALITY, WHICH HAD BEEN PREPARED USING A DRILL. THE FRAGMENT WAS NOT RETRIEVED. THERE WAS NO DELAY IN THE PROCEDURE, AND THE IMPLANT WAS SUCCESSFULLY PLACED.
Patient problems: Foreign Body In Patient
MAUDE report 23906940 ↗MalfunctionJul 31, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3730SP DOUBLE LOADED KNEE FIBERTAK ANCHOR INSERTER BENT IMMEDIATELY FOLLOWING GENTLE IMPACTION. THE BENT PIECE WAS RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED BY USING ANOTHER IMPLANT. THIS WAS DISCOVERED DURING A LET PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 07/21/2025: DURING THE PROCEDURE, THE INSERTER BENT AND BROKE OUTSIDE OF THE PATIENT, AND IT WAS CONFIRMED THAT NO FRAGMENTS REMAINED IN THE SURGICAL SITE. ALL BROKEN PIECES WERE SUCCESSFULLY RETRIEVED. A REPLACEMENT AR-3730SP WAS UTILIZED TO COMPLETE THE CASE WITHOUT DELAY OR THE NEED FOR ADDITIONAL ANESTHESIA. THE BONE SOCKET WAS PREPARED USING THE 2.6 MM DRILL FROM THE AR-3712, AND THE PATIENT¿S BONE QUALITY WAS ASSESSED AS GOOD. NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22675899 ↗MalfunctionJun 3, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3730SP DOUBLE LOADED KNEE FIBERTAK DID NOT DEPLOY. THE PRONGS ON THE INSERTER BENT OUT. THE CASE WAS COMPLETED USING ANOTHER AR-3730SP DOUBLE LOADED KNEE FIBERTAK. THIS WAS DISCOVERED DURING A PROCEDURE. THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135432 ↗MalfunctionFeb 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 02/05/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (QTY. 2) AN AR-3730SP DOUBLE LOADED KNEE FIBERTAK ANCHOR PULLED OUT OF THE IMPLANTATION SITE WHEN IMPLANTED. THIS OCCURRED BEFORE THE STITCHING WAS ATTEMPTED TO BE TIGHTENED. THERE WAS A MINIMAL DELAY IN REMOVING BOTH (QTY. 2) OF AN AR-3730SP DOUBLE LOADED KNEE FIBERTAK ANCHOR IN ONE PIECE. THE CASE WAS COMPLETED USING A NON-ARTHREX PRODUCT. THIS WAS DISCOVERED DURING A PATELLA TENDON REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21434967 ↗MalfunctionFeb 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (QTY. 2) AN AR-3730SP DOUBLE LOADED KNEE FIBERTAK ANCHOR PULLED OUT OF THE IMPLANTATION SITE WHEN IMPLANTED. THIS OCCURRED BEFORE THE STITCHING WAS ATTEMPTED TO BE TIGHTENED. THERE WAS A MINIMAL DELAY IN REMOVING BOTH (QTY. 2) OF AN AR-3730SP DOUBLE LOADED KNEE FIBERTAK ANCHOR IN ONE PIECE. THE CASE WAS COMPLETED USING A NON-ARTHREX PRODUCT. THIS WAS DISCOVERED DURING A PATELLA TENDON REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21434909 ↗MalfunctionMar 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 2/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-3730SP DOUBLE LOADED KNEE FIBERTAK ANCHOR WOULD NOT SEAT PROPERLY DURING INSERTION AND WERE UNABLE TO CAPTURE. THE CASE WAS COMPLETED USING ANOTHER AR-3730SP DOUBLE-LOADED KNEE FIBER TAP ANCHOR FROM THE SAME LOT WITH NO ISSUES. THERE WAS A FEW MINUTE DELAY IN REMOVING THE ANCHORS THAT WOULD NOT SEAT. NOTHING BROKE INSIDE THE PATIENT, AND NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING AN MCL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18836705 ↗MalfunctionMar 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 2/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-3730SP DOUBLE LOADED KNEE FIBERTAK ANCHOR WOULD NOT SEAT PROPERLY DURING INSERTION AND WERE UNABLE TO CAPTURE. THE CASE WAS COMPLETED USING ANOTHER AR-3730SP DOUBLE-LOADED KNEE FIBER TAP ANCHOR FROM THE SAME LOT WITH NO ISSUES. THERE WAS A FEW MINUTE DELAY IN REMOVING THE ANCHORS THAT WOULD NOT SEAT. NOTHING BROKE INSIDE THE PATIENT, AND NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING AN MCL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18836652 ↗MalfunctionFeb 23, 2024Material Twisted/Bent; Material Twisted/Bent
ON 02/1/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3730SP DOUBLE LOADED KNEE SELF-PUNCHING FIBERTAK INSERTER BENT DURING INSERTION CAUSING DAMAGES TO THE SUTURE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18767826 ↗MalfunctionFeb 6, 2024Break; Break
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 18652481 ↗MalfunctionFeb 6, 2024Break; Break
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 18652295 ↗MalfunctionFeb 5, 2024Break; Break
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 18642068 ↗MalfunctionJan 30, 2024Material Twisted/Bent; Material Twisted/Bent
ON 01/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT (2) AR-3730SP DOUBLE LOADED KNEE FIBERTAK® ANCHOR BENT. THIS OCCURRED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 18610366 ↗MalfunctionJan 30, 2024Material Twisted/Bent; Material Twisted/Bent
ON 01/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT (2) AR-3730SP DOUBLE LOADED KNEE FIBERTAK® ANCHOR BENT. THIS OCCURRED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 18608810 ↗MalfunctionOct 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 9/26/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT (2) AR-3730SP DOUBLE LOADED KNEE FIBERTAK ANCHORS PULLED OUT. THE CASE WAS COMPLETED USING ANOTHER AR-3730SP DOUBLE LOADED KNEE FIBERTAK. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2023. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 17966454 ↗MalfunctionOct 13, 2023Failure to Advance; Failure to Advance
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-3730SP DOUBLE LOADED KNEE FIBERTAK WOULD NOT INSERT IN THE PATIENT'S PATELLA THROUGH THE DRILL GUIDE. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6) 2023.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 17931038 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
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- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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