Arthrex® AR-3638DHCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867295544), received between Oct 12, 2023 and Oct 31, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED ON 10/25/2024: THE SALES REPRESENTATIVE HAS REPORTED THAT THE AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK INSERTER GOT STUCK IN THE AR-3638DHC DISPOSABLE KIT. THE CASE WAS COMPLETED USING A NEW AR-3638DHC DISPOSABLE KIT AND THE AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK WAS ABLE TO BE IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 20576757 ↗
• MalfunctionOct 25, 2024Fitting Problem; Fitting Problem

  ON 10/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE IMPLANT GOT STUCK IN AN AR-3638DHC DISPOSABLE KIT FOR KNOTLESS HIP FIBERTAK. THE ANCHOR GOT STUCK AND COULD NOT COME OUT. A NEW ANCHOR WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534348 ↗
• MalfunctionJun 7, 2024Mechanical Jam; Mechanical Jam

  ON 10/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638DHC FIBERTAK CURVED DRILL GUIDE WAS EXTREMELY TIGHT AND AN AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK WOULD NOT CINCH DOWN ALL THE WAY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488409 ↗
• MalfunctionJan 3, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3636H FIBERTAK INSERTER BROKE WHILE INSERTING. SIGNIFICANT PORTION BROKE OFF, >3CM. PORTION HAD TO BE DRILLED OUT. SURGEON COULD NOT REMOVE THE TIP OF THE INSERTER AND WAS LEFT IN THE BONE. THIS WAS DISCOVERED DURING USE IN A CASE, DELAY 10 MINUTES. CASE COMPLETED USING ADDITIONAL ANCHORS. AR-3638DHC IS THE SUSPECTED CAUSE OF THE BREAK. THE GUIDE DID NOT APPROPRIATELY LINE UP THE ANCHOR TO THE HOLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18436834 ↗
• MalfunctionNov 2, 2023Break; Break

  ON 10/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3636H SELF BUNCHING KL 1.8 FIBERTAK, HIP, AND AN AR-3638DHC DISPOSABLES KIT FOR KNOTLESS HIP FIBERTAK SUTURE ANCHOR, CURVED HAD AN ISSUE. DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2023, WHEN THE SURGEON WAS TRYING TO PUT THE 4TH ANCHOR IN, SHE DRILLED AS PER THE REQUIRED TECHNIQUE AND FELT RESISTANCE WHEN INSERTING THE ANCHOR. WHEN USING A MALLET TO INSERT THE ANCHOR, A PART OF THE METAL INSERTION SHAFT BROKE OFF INSIDE THE PATIENT'S BONE. THE BROKEN PIECE WAS ABLE TO BE REMOVED BY 90%, BUT THE DISTAL END REMAINED IN THE BONE. ANOTHER LARGER ANCHOR FROM A COMPETITOR WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO HARM TO THE PATIENT. THERE WAS A CASE DELAY OF 30 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. AFTER THE PROCEDURE, IT WAS NOTICED THAT THE CURVED GUIDE LOOKED SLIGHTLY BENT, AND THE DRILL WASN'T ENTERING THROUGH THE DEVICE AS IT NORMALLY DID. NOTHING HAD BROKEN OFF THE CURVED GUIDE. BOTH DEVICES WERE AVAILABLE FOR RETURN. NO PICTURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055661 ↗
• MalfunctionOct 12, 2023Use of Device Problem; Use of Device Problem

  ON 09/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (3) AR-3638DHC KNOTLESS HIP FIBERTAK'S DRILL WOULD SIMPLY NOT EXIT THE END OF THE DRILL GUIDE FOR ANY OF THEM. THIS OCCURRED DURING A CASE ON (B)(6) 2023. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17919375 ↗