Arthrex® AR-3602H-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867295537), received between Jan 24, 2022 and Jun 9, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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.

• MalfunctionJun 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY WITH ACETABULAR LABRUM REPAIR, THE IMPLANTS OF THE AR-3602H-1 (CASE-(B)(4) TO -5) FAILED TO ACHIEVE ADEQUATE BONE FIXATION AND SUBSEQUENTLY PULLED OUT. ADDITIONALLY, THE BLUE SUTURE OF ONE AR-3636H-1 (CASE-(B)(4) BECAME JAMMED, PREVENTING THE LOOP FROM BEING TIGHTENED. FOR ANOTHER AR-3636H-1 (CASE-(B)(4), THE SUTURE WAS SEVERED BY THE INSERTER. FURTHERMORE, TWO IMPLANTS OF THE AR-3636H-1 (CASE-(B)(4) AND CASE-(B)(4) FAILED TO ACHIEVE ADEQUATE FIXATION AND PULLED OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH NEW DEVICES FROM ARTHREX AND STRYKER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443962 ↗
• MalfunctionJun 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY WITH ACETABULAR LABRUM REPAIR, THE IMPLANTS OF THE AR-3602H-1 ((B)(4)) FAILED TO ACHIEVE ADEQUATE BONE FIXATION AND SUBSEQUENTLY PULLED OUT. ADDITIONALLY, THE BLUE SUTURE OF ONE AR-3636H-1 ((B)(4)) BECAME JAMMED, PREVENTING THE LOOP FROM BEING TIGHTENED. FOR ANOTHER AR-3636H-1 ((B)(4)), THE SUTURE WAS SEVERED BY THE INSERTER. FURTHERMORE, TWO IMPLANTS OF THE AR-3636H-1 ((B)(4)) FAILED TO ACHIEVE ADEQUATE FIXATION AND PULLED OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH NEW DEVICES FROM ARTHREX AND STRYKER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443958 ↗
• MalfunctionJun 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY WITH ACETABULAR LABRUM REPAIR, THE IMPLANTS OF THE AR-3602H-1 (CASE-(B)(4) TO -5) FAILED TO ACHIEVE ADEQUATE BONE FIXATION AND SUBSEQUENTLY PULLED OUT. ADDITIONALLY, THE BLUE SUTURE OF ONE AR-3636H-1 (CASE-(B)(4) BECAME JAMMED, PREVENTING THE LOOP FROM BEING TIGHTENED. FOR ANOTHER AR-3636H-1 (CASE-(B)(4), THE SUTURE WAS SEVERED BY THE INSERTER. FURTHERMORE, TWO IMPLANTS OF THE AR-3636H-1 (CASE-(B)(4) AND CASE-(B)(4) FAILED TO ACHIEVE ADEQUATE FIXATION AND PULLED OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH NEW DEVICES FROM ARTHREX AND STRYKER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443936 ↗
• MalfunctionJun 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY WITH ACETABULAR LABRUM REPAIR, THE IMPLANTS OF THE AR-3602H-1 (CASE (B)(4)) FAILED TO ACHIEVE ADEQUATE BONE FIXATION AND SUBSEQUENTLY PULLED OUT. ADDITIONALLY, THE BLUE SUTURE OF ONE AR-3636H-1 (CASE (B)(4)) BECAME JAMMED, PREVENTING THE LOOP FROM BEING TIGHTENED. FOR ANOTHER AR-3636H-1 (CASE (B)(4)), THE SUTURE WAS SEVERED BY THE INSERTER. FURTHERMORE, TWO IMPLANTS OF THE AR-3636H-1 (CASE (B)(4) AND CASE (B)(4)) FAILED TO ACHIEVE ADEQUATE FIXATION AND PULLED OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH NEW DEVICES FROM ARTHREX AND STRYKER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443930 ↗
• MalfunctionMay 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ACETABULAR LABRAL REPAIR SURGERY WHEN INSERTING THE DEVICE, IT COULD NOT STAY IN THE BONE. NO PART OF THE DEVICE BROKE OFF. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312525 ↗
• MalfunctionJan 24, 2022Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY THE TIP OF THE DEVICE BENT DURING INSERTION. A PIECE OF THE DEVICE BROKE OFF INSIDE THE PATIENT. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 13333848 ↗