Arthrex® AR-3638H-1Recalls & reported problems
Arthrex, Inc. · KNOTLESS HIP FiberTak · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867295575), received between May 24, 2021 and Dec 3, 2025 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (7 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.
Reports received per month
Most reported problems
Device problems
- Positioning Failure7
- Failure to Advance2
- Material Split, Cut or Torn2
- Device Dislodged or Dislocated1
- Difficult to Advance1
- Material Rupture1
Patient problems
- Insufficient Information7
- No Clinical Signs, Symptoms or Conditions4
- Failure of Implant1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON 14 NOVEMBER 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-3638H-1, KNOTLESS HIP FIBERTAK WERE REPORTED TO HAVE CUT THE SHUTTLING SUTURE ONCE INSERTED. THIS OCCURRED ON (B)(6) 2025 DURING A HIP LABRAL REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING A HIP LENGTH PUSHLOCK. THERE WAS CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 23703825 ↗MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-3638H-1, KNOTLESS HIP FIBERTAK WERE REPORTED TO HAVE CUT THE SHUTTLING SUTURE ONCE INSERTED. THIS OCCURRED ON (B)(6) 2025 DURING A HIP LABRAL REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING A HIP LENGTH PUSHLOCK. THERE WAS CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 23703763 ↗MalfunctionMay 19, 2025Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated
ON 24 APRIL 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-3638H-1 KNOTLESS HIP FIBERTAK AND ONE AR-2923PS, SUTR ANCHPEEK P-LCK2.9X 12.5MM WERE REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2025 DURING A RIGHT HIP ARTHROSCOPY & LABRAL REPAIR. IT WAS REPORTED SURGEON PERFORMING A LABRAL REPAIR OF RIGHT HIP. SURGEON USING KNOTLESS HIP FIBERTAK SUTURE ANCHORS. 2X ANCHORS DEPLOYED ALREADY INTO JOINT. STAFF OPENED A 3RD ANCHOR. UNFORTUNATELY, THE SUTURES HAD UNRAVELLED FROM THE INSERTER AND WERE UNABLE TO BE RE-POSITIONED ONTO THE INSERTER. A 4TH ANCHOR WAS THEN OPENED AND USED, AND UNFORTUNATELY PULLED STRAIGHT BACK OUT. ALL PIECES OF THE SUTURE ANCHOR REMOVED FROM THE JOINT. SURGEON THEN OPTED TO USE A HIP PUSHLOCK ANCHOR WITH 1.3MM SUTURE TAPE. UPON INSERTION, IT WAS NOTED THAT THE EYELET BROKE. LIKELY DUE TO SUBOPTIMAL TRAJECTORY ON INSERTION. THE ANCHOR WAS REMOVED WITH NO PIECES REMAINING IN JOINT. THE CASE WAS COMPLETED SUCCESSFULLY USING A STRYKER CINCLOCK. THERE WAS CASE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043881 ↗MalfunctionApr 30, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE IMPLANT DID NOT GRIP. 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 21937446 ↗MalfunctionApr 25, 2025Positioning Failure; Positioning Failure
ON 24 APRIL 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-3638H-1 KNOTLESS HIP FIBERTAK AND ONE AR-2923PS, SUTR ANCHPEEK P-LCK2.9X 12.5MM WERE REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2025 IN (B)(6) DURING A RIGHT HIP ARTHROSCOPY & LABRAL REPAIR. IT WAS REPORTED SURGEON PERFORMING A LABRAL REPAIR OF RIGHT HIP. SURGEON USING KNOTLESS HIP FIBERTAK SUTURE ANCHORS. 2X ANCHORS DEPLOYED ALREADY INTO JOINT. STAFF OPENED A 3RD ANCHOR. UNFORTUNATELY, THE SUTURES HAD UNRAVELLED FROM THE INSERTER AND WERE UNABLE TO BE RE-POSITIONED ONTO THE INSERTER. A 4TH ANCHOR WAS THEN OPENED AND USED, AND UNFORTUNATELY PULLED STRAIGHT BACK OUT. ALL PIECES OF THE SUTURE ANCHOR REMOVED FROM THE JOINT. SURGEON THEN OPTED TO USE A HIP PUSHLOCK ANCHOR WITH 1.3MM SUTURE TAPE. UPON INSERTION, IT WAS NOTED THAT THE EYELET BROKE. LIKELY DUE TO SUBOPTIMAL TRAJECTORY ON INSERTION. THE ANCHOR WAS REMOVED WITH NO PIECES REMAINING IN JOINT. THE CASE WAS COMPLETED SUCCESSFULLY USING A STRYKER CINCLOCK. THERE WAS CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 21910025 ↗MalfunctionOct 1, 2024Positioning Failure; Positioning Failure
ON 18 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H-1 KNOTLESS HIP FIBERTAK FAILED TO ANCHOR PROPERLY. THIS OCCURRED ON 17 AUGUST 2024 IN (B)(6) DURING A HIP LABRAL REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING FURTHER ANCHORS. THERE WAS CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 20344159 ↗MalfunctionSep 25, 2024Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance
ON 18 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H-1 KNOTLESS HIP FIBERTAK FAILED TO ANCHOR PROPERLY. THIS OCCURRED ON (B)(6) 2024 IN (B)(6)HOSPITAL DURING A HIP LABRAL REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING FURTHER ANCHORS. THERE WAS CASE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20302757 ↗MalfunctionSep 25, 2024Failure to Advance; Failure to Advance
ON 18 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H-1 KNOTLESS HIP FIBERTAK FAILED TO ANCHOR PROPERLY. THIS OCCURRED ON (B)(6) 2024 IN ST VINCENT¿S PRIVATE HOSPITAL SYDNEY DURING A HIP LABRAL REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING FURTHER ANCHORS. THERE WAS CASE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20301600 ↗MalfunctionSep 24, 2024Positioning Failure; Positioning Failure
ON 18 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H-1 KNOTLESS HIP FIBERTAK FAILED TO ANCHOR PROPERLY. THIS OCCURRED ON (B)(6) 2024 IN (B)(6) HOSPITAL DURING A HIP LABRAL REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING FURTHER ANCHORS. THERE WAS CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 20292685 ↗MalfunctionAug 7, 2024Positioning Failure; Positioning Failure
ON 25 JULY 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H-1 KNOTLESS HIP FIBERTAK WAS REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2024 IN (B)(6) DURING A HIP ARTHROSCOPY & STABILIZATION. THE IMPLANT FAILED TO ANCHOR. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER IMPLANT. THERE WAS CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 19929704 ↗MalfunctionAug 7, 2024Positioning Failure; Positioning Failure
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H-1 KNOTLESS HIP FIBERTAK WAS REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2024 IN (B)(6) HOSPITAL DURING A HIP ARTHROSCOPY & STABILIZATION. THE IMPLANT FAILED TO ANCHOR. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER IMPLANT. THERE WAS CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 19929425 ↗MalfunctionMay 24, 2021Material Rupture
IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE KNOTLESS ANCHOR WAS PLACED AND WHILE TIGHTENING THE SUTURE IT RUPTURED AND THE IMPLANT REMAINED IN THE PATIENT. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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: Failure of Implant
MAUDE report 11872311 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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