Arthrex® AR-3636H-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00888867362864), received between Feb 23, 2024 and Jun 9, 2026 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 25 most recent of 26 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-2026-00379362-2 TO -5) FAILED TO ACHIEVE ADEQUATE BONE FIXATION AND SUBSEQUENTLY PULLED OUT. ADDITIONALLY, THE BLUE SUTURE OF ONE AR-3636H-1 (CASE-2026-00379362-8) BECAME JAMMED, PREVENTING THE LOOP FROM BEING TIGHTENED. FOR ANOTHER AR-3636H-1 (CASE-2026-00379362-1), THE SUTURE WAS SEVERED BY THE INSERTER. FURTHERMORE, TWO IMPLANTS OF THE AR-3636H-1 (CASE-2026-00379362-6 AND CASE-2026-00379362-7) 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 25443986 ↗
• MalfunctionJun 9, 2026Device Damaged by Another Device

  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 25443941 ↗
• MalfunctionJun 9, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY WITH ACETABULAR LABRUM REPAIR, THE IMPLANTS OF THE AR-3602H-1 (CASE-2026-00379362-2 TO -5) FAILED TO ACHIEVE ADEQUATE BONE FIXATION AND SUBSEQUENTLY PULLED OUT. ADDITIONALLY, THE BLUE SUTURE OF ONE AR-3636H-1 (CASE-2026-00379362-8) BECAME JAMMED, PREVENTING THE LOOP FROM BEING TIGHTENED. FOR ANOTHER AR-3636H-1 (CASE-2026-00379362-1), THE SUTURE WAS SEVERED BY THE INSERTER. FURTHERMORE, TWO IMPLANTS OF THE AR-3636H-1 (CASE-2026-00379362-6 AND CASE-2026-00379362-7) 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 25443902 ↗
• 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 25443879 ↗
• MalfunctionApr 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SURGERY THE ANCHOR PULLED OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000785 ↗
• MalfunctionApr 9, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ANCHOR CAME LOOSE DURING INSTALLATION. 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 24834751 ↗
• MalfunctionApr 9, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE WIRES GOT STUCK WHEN HANDLING THE DEVICE. 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 24834715 ↗
• MalfunctionApr 9, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE WIRES GOT STUCK WHEN HANDLING THE DEVICE. 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 24834712 ↗
• MalfunctionApr 9, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE WIRES GOT STUCK WHEN HANDLING THE DEVICE. 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 24834710 ↗
• MalfunctionApr 9, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE WIRES GOT STUCK WHEN HANDLING THE DEVICE. 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 24834707 ↗
• MalfunctionApr 9, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ANCHOR CAME LOOSE DURING INSTALLATION. 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 24834701 ↗
• MalfunctionMar 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY - FEMORAL ACETABULAR CONFLICT AND LABRUM REPAIR SURGERY THE SWIFSTICH HAD A BROKEN NEEDLE, SO WHEN THEY WANTED TO PULL OUT THE PART THAT HOLDS THE FIBERWIRE, THE NEEDLE CAME OUT. AS FOR THE KNOTLESS FIBERTAK, AFTER TUNNELING WITH THE DRILL BIT, WHEN THEY INSERTED THE ANCHOR INTO THE GUIDE, THE TIP OF THE HANDLE BROKE OFF. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. 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. ON (B)(6) 2025 -SAC: RECEIVED FURTHER INFORMATION THAT THE REFERENCE AR-4068HL WAS ALREADY DAMAGED BEFORE IT WAS USED. THE NEEDLE WAS NOT ATTACHED TO ITS HANDLE. FURTHERMORE, FOR THE REFERENCE AR-3636H, THE TIP OF THE ANCHOR HANDLE BROKE AS SOON AS THE SURGEON USED THE HAMMER TO INSERT IT INTO THE TUNNEL. WHEN CHANGING THE DRILL BIT FOR THE ANCHOR, THERE WAS NO CHANCE IN THE DIRECTION OF THE GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708529 ↗
• MalfunctionOct 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY WITH LEBRAL REPAIR THE BLUE REPAIR SUTURE SNAPPED WHEN IT WAS REDUCED DOWN TO THE LABRUM. IN ADDITION THE WHITE SHUTTLE SUTURE OF ANOTHER ANCHOR TORE WHILE FLOSSING AS WELL. THE ANCHORS REMAINED INSIDE THE PATIENT BUT THE SUTURES WERE CUT AND FLUSHED OUT. 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: Foreign Body In Patient

  MAUDE report 20522016 ↗
• MalfunctionOct 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY WITH LEBRAL REPAIR THE BLUE REPAIR SUTURE SNAPPED WHEN IT WAS REDUCED DOWN TO THE LABRUM. IN ADDITION THE WHITE SHUTTLE SUTURE OF ANOTHER ANCHOR TORE WHILE FLOSSING AS WELL. THE ANCHORS REMAINED INSIDE THE PATIENT BUT THE SUTURES WERE CUT AND FLUSHED OUT. 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: Foreign Body In Patient

  MAUDE report 20522012 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP LABRAL REPAIR SURGERY THE TIP OF AR-3636H-1 METAL SHAFT SNAPPED OFF AND GOT STUCK IN THE HOLE DRILLED IN THE PATIENTS ACETABULUM. THE METAL TIP WAS ONLY NOTICED ON AN X-RAY AT THE END OF SURGERY. 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: Insufficient Information

  MAUDE report 20352618 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP LABRAL REPAIR SURGERY WHEN THE SURGEON PULLED ON THE SHUTTLE SUTURE TO TRANSFER THE REPAIR SUTURE BACK INTO THE ANCHOR, THE SHUTTLE SUTURE BROKE INTO 2 PIECES AND THE ANCHOR WAS THEREFORE UNUSABLE. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. 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. ON (B)(6) 2024 DW ON (B)(6) 2024: FURTHER INFORMATION WERE PROVIDED THAT THE ANCHOR REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19212328 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP LABRAL REPAIR SURGERY WHEN THE SURGEON PULLED ON THE SHUTTLE SUTURE TO TRANSFER THE REPAIR SUTURE BACK INTO THE ANCHOR, THE SHUTTLE SUTURE BROKE INTO 2 PIECES AND THE ANCHOR WAS THEREFORE UNUSABLE. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. 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. 11-APR-2024 DW 15-APR-2024: FURTHER INFORMATION WERE PROVIDED THAT THE ANCHOR REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19212235 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP LABRAL REPAIR SURGERY WHEN THE SURGEON PULLED ON THE SHUTTLE SUTURE TO TRANSFER THE REPAIR SUTURE BACK INTO THE ANCHOR, THE SHUTTLE SUTURE BROKE INTO 2 PIECES AND THE ANCHOR WAS THEREFORE UNUSABLE. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. 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. *** UPDATE 11-APR-2024 DW: FURTHER INFORMATION WERE PROVIDED THAT THE ANCHOR REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19211899 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP LABRAL REPAIR SURGERY WHEN THE SURGEON PULLED ON THE SHUTTLE SUTURE TO TRANSFER THE REPAIR SUTURE BACK INTO THE ANCHOR, THE SHUTTLE SUTURE BROKE INTO 2 PIECES AND THE ANCHOR WAS THEREFORE UNUSABLE. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. 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. UPDATE 11-APR-2024 DW: FURTHER INFORMATION WERE PROVIDED THAT THE ANCHOR REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19211863 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP LABRAL REPAIR SURGERY WHEN THE SURGEON PULLED ON THE SHUTTLE SUTURE TO TRANSFER THE REPAIR SUTURE BACK INTO THE ANCHOR, THE SHUTTLE SUTURE BROKE INTO 2 PIECES AND THE ANCHOR WAS THEREFORE UNUSABLE. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. 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. *** UPDATE 11-APR-2024 DW: FURTHER INFORMATION WERE PROVIDED THAT THE ANCHOR REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19211817 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP LABRAL REPAIR SURGERY THE TIP OF ANCHOR BROKE OFF INTO THE BONE. THE SURGEON WAS UNABLE TO RETRIEVE THE FRAGMENT, BUT WAS CONFIDENT THAT THE FRAGMENT IS NOT IN THE JOINT SPACE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18838448 ↗
• MalfunctionFeb 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LABRAL REPAIR HIP SURGERY TWO ANCHORS BROKE OFF INSIDE THE PATIENT. THE SURGEON BURRED AWAY THE ACETABULUM IN ORDER TO GET THE BROKEN PIECE. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. FURTHER IT WAS REPORTED THAT THE SURGEON ABANDONED THE REPAIR. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. ***UPDATE SWIT 02-FEB-2024: A KL HIP SURGERY WITH FIBERTAK DRIVER SHAFT SURGERY WAS PERFORMED. WITH TWO ANCHORS PART OF THE SHAFT BROKE OFF IN THE PATIENT'S BONE AND HAD TO BE FISHED OUT. CORRECT TECHNIQUE WAS USED. IT TOOK ONE AND HALF HOURS FOR THE SURGEON ATTEMPTED TO FISH THE BROKEN PIECES (ONE OF THE SHAFTS BROKE INTO 3 SEPARATE BITS) OUT OF THE PATIENT'S ACETABULUM WITH GREAT DIFFICULTY. ***UPDATE SWIT 12-FEB-2024: THE OTHER THREE ANCHORS PULLED OUT. HE DECIDED TO CARRY OUT WITH THE REPAIR AND JUST BURRED THE FEMORAL HEAD. THE SURGEON DID NOT WANT TO REPAIR THE LABRUM ANYMORE SO ABANDONED THAT PART OF THE SURGERY. THE SURGEON SAID THAT HIM BURRING THE HEAD AWAY STILL HELPED WITH IMPINGEMENT. THE ONE ANCHOR WAS LEFT INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18766102 ↗
• InjuryFeb 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LABRAL REPAIR HIP SURGERY TWO ANCHORS BROKE OFF INSIDE THE PATIENT. THE SURGEON BURRED AWAY THE ACETABULUM IN ORDER TO GET THE BROKEN PIECE. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. FURTHER IT WAS REPORTED THAT THE SURGEON ABANDONED THE REPAIR. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE SWIT (B)(6) 2024: A KL HIP SURGERY WITH FIBERTAK DRIVER SHAFT SURGERY WAS PERFORMED. WITH TWO ANCHORS PART OF THE SHAFT BROKE OFF IN THE PATIENT'S BONE AND HAD TO BE FISHED OUT. CORRECT TECHNIQUE WAS USED. IT TOOK ONE AND HALF HOURS FOR THE SURGEON ATTEMPTED TO FISH THE BROKEN PIECES (ONE OF THE SHAFTS BROKE INTO 3 SEPARATE BITS) OUT OF THE PATIENT'S ACETABULUM WITH GREAT DIFFICULTY. UPDATE SWIT (B)(6) 2024: THE OTHER THREE ANCHORS PULLED OUT. HE DECIDED TO CARRY OUT WITH THE REPAIR AND JUST BURRED THE FEMORAL HEAD. THE SURGEON DID NOT WANT TO REPAIR THE LABRUM ANYMORE SO ABANDONED THAT PART OF THE SURGERY. THE SURGEON SAID THAT HIM BURRING THE HEAD AWAY STILL HELPED WITH IMPINGEMENT. THE ONE ANCHOR WAS LEFT INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18766093 ↗
• InjuryFeb 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LABRAL REPAIR HIP SURGERY TWO ANCHORS BROKE OFF INSIDE THE PATIENT. THE SURGEON BURRED AWAY THE ACETABULUM IN ORDER TO GET THE BROKEN PIECE. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. FURTHER IT WAS REPORTED THAT THE SURGEON ABANDONED THE REPAIR. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE SWIT: ON (B)(6) 2024: A KL HIP SURGERY WITH FIBERTAK DRIVER SHAFT SURGERY WAS PERFORMED. WITH TWO ANCHORS PART OF THE SHAFT BROKE OFF IN THE PATIENT'S BONE AND HAD TO BE FISHED OUT. CORRECT TECHNIQUE WAS USED. IT TOOK ONE AND HALF HOURS FOR THE SURGEON ATTEMPTED TO FISH THE BROKEN PIECES (ONE OF THE SHAFTS BROKE INTO 3 SEPARATE BITS) OUT OF THE PATIENT'S ACETABULUM WITH GREAT DIFFICULTY. UPDATE SWIT: ON (B)(6) 2024: THE OTHER THREE ANCHORS PULLED OUT. HE DECIDED TO CARRY OUT WITH THE REPAIR AND JUST BURRED THE FEMORAL HEAD. THE SURGEON DID NOT WANT TO REPAIR THE LABRUM ANYMORE SO ABANDONED THAT PART OF THE SURGERY. THE SURGEON SAID THAT HIM BURRING THE HEAD AWAY STILL HELPED WITH IMPINGEMENT. THE ONE ANCHOR WAS LEFT INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18766084 ↗
• InjuryFeb 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR HIP SURGERY TWO ANCHORS BROKE OFF INSIDE THE PATIENT. THE SURGEON BURRED AWAY THE ACETABULUM IN ORDER TO GET THE BROKEN PIECE. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. FURTHER IT WAS REPORTED THAT THE SURGEON ABANDONED THE REPAIR. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. ***UPDATE SWIT 02-FEB-2024: A KL HIP SURGERY WITH FIBERTAK DRIVER SHAFT SURGERY WAS PERFORMED. WITH TWO ANCHORS PART OF THE SHAFT BROKE OFF IN THE PATIENT'S BONE AND HAD TO BE FISHED OUT. CORRECT TECHNIQUE WAS USED. IT TOOK ONE AND HALF HOURS FOR THE SURGEON ATTEMPTED TO FISH THE BROKEN PIECES (ONE OF THE SHAFTS BROKE INTO 3 SEPARATE BITS) OUT OF THE PATIENT'S ACETABULUM WITH GREAT DIFFICULTY. ***UPDATE SWIT 12-FEB-2024: THE OTHER THREE ANCHORS PULLED OUT. HE DECIDED TO CARRY OUT WITH THE REPAIR AND JUST BURRED THE FEMORAL HEAD. THE SURGEON DID NOT WANT TO REPAIR THE LABRUM ANYMORE SO ABANDONED THAT PART OF THE SURGERY. THE SURGEON SAID THAT HIM BURRING THE HEAD AWAY STILL HELPED WITH IMPINGEMENT. THE ONE ANCHOR WAS LEFT INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18766080 ↗