Arthrex® AR-3636HRecalls & reported problems

Summary

The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 00888867362888), received between Jan 11, 2022 and Sep 22, 2026 — classified as 5 injuries, 178 malfunctions.

The most frequently reported specific device problem is “Break” (102 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 183 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  On 10-Sep-2026, it was reported by an Arthrex Subsidiary Employee via (b)(4) that an AR-3636H FiberTak anchor suture was broken when the penetrator forceps was passed through the labrum. This was discovered during use with no patient harm. Additional information has been requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855357 ↗
• MalfunctionSep 17, 2026Failure to Advance

  On 03-Sep-2026, a sales representative reported via email that an AR-3636H Self-Bunching 1.8 Knotless Hip FiberTak Soft Anchor had an issue during use. The suture did not convert when it was shuttled through the eyelet. The anchor remained implanted in the patient; however, the suture was cut and an additional anchor was implanted to complete the procedure. This was discovered during a hip arthroscopy procedure on 27-Aug-2026. The patient outcome was not reported.Additional information was received on 15-Sep-2026:The failure occurred prior to the repair suture entering the conversion. No visible defects were noted on the suture, eyelet, or anchor. A replacement device of the same part number, AR-3636H, was used to complete the procedure. The surgery was delayed approximately 3 to 5 minutes. No portion of the implant or instrument broke during the event. The implant remained in place and the suture was cut. An additional 3 to 5 minutes of anesthesia was administered due to the procedural delay. No patient injury or adverse outcome was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806128 ↗
• MalfunctionSep 1, 2026Device Dislodged or Dislocated

  On (b)(6) 2026, it was reported by a sales Representative via (b)(6) that an AR-3636H self-bunching fibertak anchor pulled out during a rotator cuff repair. Noticed during a case, anchor removed, and case completed with no device with no patient effect.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546652 ↗
• MalfunctionJul 31, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105499 ↗
• MalfunctionJul 27, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017382 ↗
• MalfunctionFeb 12, 2026Break

  ON 26-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (3) AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK®SOFT ANCHORS SHUTTLING STITCHES BROKE. THIS OCCURRED DURING A HIP LABRAL REPAIR ON (B)(6) 2026. WHILE SHUTTLING THE REPAIR STITCH, THE SHUTTLING STITCH BROKE ON ALL 3 DEVICES. THE DEVICES WERE REMOVED FROM THE PATIENT. THE PATIENT HAD GOOD BONE QUALITY, WHICH WAS PREPPED USING THE PROPER DRILL GUIDE. THE CASE WAS DELAYED ABOUT FIVE MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE CONTINUED USING (2) ADDITIONAL AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK®SOFT ANCHORS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322248 ↗
• MalfunctionFeb 12, 2026Break

  ON 26-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (3) AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK®SOFT ANCHORS SHUTTLING STITCHES BROKE. THIS OCCURRED DURING A HIP LABRAL REPAIR ON (B)(6) 2026. WHILE SHUTTLING THE REPAIR STITCH, THE SHUTTLING STITCH BROKE ON ALL 3 DEVICES. THE DEVICES WERE REMOVED FROM THE PATIENT. THE PATIENT HAD GOOD BONE QUALITY, WHICH WAS PREPPED USING THE PROPER DRILL GUIDE. THE CASE WAS DELAYED ABOUT FIVE MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE CONTINUED USING (2) ADDITIONAL AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK®SOFT ANCHORS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322175 ↗
• MalfunctionFeb 12, 2026Break

  ON 26-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (3) AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK®SOFT ANCHORS SHUTTLING STITCHES BROKE. THIS OCCURRED DURING A HIP LABRAL REPAIR ON (B)(6) 2026. WHILE SHUTTLING THE REPAIR STITCH, THE SHUTTLING STITCH BROKE ON ALL 3 DEVICES. THE DEVICES WERE REMOVED FROM THE PATIENT. THE PATIENT HAD GOOD BONE QUALITY, WHICH WAS PREPPED USING THE PROPER DRILL GUIDE. THE CASE WAS DELAYED ABOUT FIVE MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE CONTINUED USING (2) ADDITIONAL AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK®SOFT ANCHORS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322125 ↗
• InjuryFeb 10, 2026Break

  ON 21-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3636H SELF-BUNCHING 1.8 KNOTLESS HIP FIBERTAK ANCHOR WAS PREDRILLED THROUGH A CURVED GUIDE AND INSERTED USING MALLET TAPS. RESISTANCE WAS ENCOUNTERED DURING INSERTION, AND TAPPING CONTINUED UNTIL THE GUIDE SLIPPED AND SHIFTED SLIGHTLY. AFTER THE INSERTER WAS REMOVED, THE SURGEON EXAMINED THE TIP AND OBSERVED THAT IT HAD FRACTURED. THE SURGEON CHOSE NOT TO LEAVE THE FRACTURED INSERTER TIP IN THE ACETABULUM AND PROCEEDED WITH REMOVAL. THE ANCHOR SUTURES WERE CUT FIRST, AND APPROXIMATELY 4¿5 MM OF LOCALIZED BONE WAS REMOVED TO RETRIEVE THE TIP. THIS ADDED AN ESTIMATED 45 MINUTES TO THE PROCEDURE TIME. AFTER THE FRACTURED INSERTER TIP WAS REMOVED, TWO ADDITIONAL ANCHORS WERE IMPLANTED TO COMPLETE THE LABRAL REPAIR. THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY WITH LABRAL REPAIR PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 30-JAN-2026: THE PROCEDURE WAS DELAYED APPROXIMATELY 45 MINUTES TO RETRIEVE THE BROKEN PIECE, RESULTING IN ADDITIONAL ANESTHESIA TIME. THE BONE QUALITY DURING INSERTION WAS ASSESSED AS HARD.

  Patient problems: Insufficient Information

  MAUDE report 24305890 ↗
• MalfunctionJan 15, 2026Break

  ON 30-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE TIPS OF TWO AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHORS BROKE OFF IN THE PATIENT. THE CASE WAS COMPLETED USING MORE ANCHORS. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 02-JAN-2026: DURING THE PROCEDURE, BOTH AR-3636H SELF-BUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHORS BROKE OFF WHILE BEING ADVANCED, INITIALLY BY HAND AND THEN WITH MALLET TAPPING. THE TIPS OF BOTH INSERTERS BECAME LODGED IN THE BONE AND REMAIN IN THE PATIENT. THE SURGERY WAS COMPLETED USING ADDITIONAL AR-3636H SELF-BUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHORS. THE EVENT RESULTED IN A ONE-HOUR SURGICAL DELAY AND ONE HOUR OF ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 24078446 ↗
• MalfunctionJan 15, 2026Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE TIPS OF TWO AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHORS BROKE OFF IN THE PATIENT. THE CASE WAS COMPLETED USING MORE ANCHORS. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 02-JAN-2026: DURING THE PROCEDURE, BOTH AR-3636H SELF-BUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHORS BROKE OFF WHILE BEING ADVANCED, INITIALLY BY HAND AND THEN WITH MALLET TAPPING. THE TIPS OF BOTH INSERTERS BECAME LODGED IN THE BONE AND REMAIN IN THE PATIENT. THE SURGERY WAS COMPLETED USING ADDITIONAL AR-3636H SELF-BUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHORS. THE EVENT RESULTED IN A ONE-HOUR SURGICAL DELAY AND ONE HOUR OF ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 24078408 ↗
• MalfunctionJan 13, 2026Material Split, Cut or Torn

  ON 31-DEC-2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-3636H SELF BUNCHING KL, WHEN THE DOCTOR PLACES THE ANCHOR AND MAKES THE TURN TO TIE THE ANCHOR KNOT, THE SUTURE IS CUT WHEN IT IS PASSED THROUGH (BLUE REPAIR SUTURE). THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054113 ↗
• MalfunctionJan 13, 2026Device Dislodged or Dislocated

  ON 31-DEC-2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT THE ANCHORS OF AN AR-3636H SOFT ANCHOR SELF-BUNCHING KNOTLESS HIP FIBERTAK CAME OUT DURING A CASE. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052498 ↗
• MalfunctionJan 6, 2026Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3636H SELF-BUNCHING HIP KNOTLESS 1.8 FIBERTAK WAS PLACED AND SHUTTLED USING THE STANDARD TECHNIQUE. THE SHUTTLE STITCH WAS CHECKED AND CONFIRMED TO BE SLIDING FREELY, BUT DURING THE ACTUAL SHUTTLING OF THE REPAIR STITCH, THE SHUTTLE STITCH BROKE. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 29-DEC-2025: THIS OCCURRED DURING A HIP LABRAL REPAIR PROCEDURE. ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED USING A REPLACEMENT AR-3636H SELF-BUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHOR. THE CASE WAS DELAYED; HOWEVER, THE DURATION AND WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23975075 ↗
• MalfunctionJan 5, 2026Device Dislodged or Dislocated

  ON 16-DEC-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3636H FIBERTAK ANCHOR PULLED OUT. IT WAS REPORTED THAT ONCE THE ANCHOR WAS INSERTED AND PASSED THROUGH THE LABRUM, WHEN ADJUSTING IT, IT PULLED OUT. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957814 ↗
• MalfunctionJan 2, 2026Break

  ON 11-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3636H SELF-BUNCHING 1.8 KNOTLESS HIP FIBERTAK EXPERIENCED AN ISSUE DURING USE. THE SHUTTLE STITCH BROKE WHILE IT WAS BEING SHUTTLED THROUGH THE ANCHOR. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 23942662 ↗
• MalfunctionJan 2, 2026Material Frayed

  ON 11-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-3636H SELF BUNCHING KNOTLESS 1.8 HIP FIBERTAK ANCHORS EXHIBITED A FRAYED BLUE STITCH AFTER THE REPAIR SUTURE WAS SHUTTLED THROUGH THE ANCHOR. THE ANCHOR WAS STILL ABLE TO TENSION; HOWEVER, IT APPEARED AS THOUGH THERE WAS AN ADDITIONAL SUTURE THAT WAS FRAYED. THIS ISSUE OCCURRED WITH THREE CONSECUTIVE ANCHORS FROM THE SAME LOT. THE ISSUE WAS DISCOVERED DURING A HIP LABRUM REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 19-DEC-2025: THE ANCHORS REMAINED IMPLANTED IN THE PATIENT AS REMOVAL WAS UNSUCCESSFUL. ALL FRAYED SUTURE MATERIAL WAS REMOVED USING A SHAVER, LEAVING ONLY THE ANCHORS IN PLACE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT AR-3636H SELF-BUNCHING KNOTLESS 1.8 HIP FIBERTAK ANCHOR. THE CASE WAS DELAYED BY APPROXIMATELY 10 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23942512 ↗
• MalfunctionJan 2, 2026Material Frayed

  ON 11-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-3636H SELF BUNCHING KNOTLESS 1.8 HIP FIBERTAK ANCHORS EXHIBITED A FRAYED BLUE STITCH AFTER THE REPAIR SUTURE WAS SHUTTLED THROUGH THE ANCHOR. THE ANCHOR WAS STILL ABLE TO TENSION; HOWEVER, IT APPEARED AS THOUGH THERE WAS AN ADDITIONAL SUTURE THAT WAS FRAYED. THIS ISSUE OCCURRED WITH THREE CONSECUTIVE ANCHORS FROM THE SAME LOT. THE ISSUE WAS DISCOVERED DURING A HIP LABRUM REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 19-DEC-2025: THE ANCHORS REMAINED IMPLANTED IN THE PATIENT AS REMOVAL WAS UNSUCCESSFUL. ALL FRAYED SUTURE MATERIAL WAS REMOVED USING A SHAVER, LEAVING ONLY THE ANCHORS IN PLACE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT AR-3636H SELF-BUNCHING KNOTLESS 1.8 HIP FIBERTAK ANCHOR. THE CASE WAS DELAYED BY APPROXIMATELY 10 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23942446 ↗
• MalfunctionDec 31, 2025Material Frayed; Material Frayed

  ON 11-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-3636H SELF BUNCHING KNOTLESS 1.8 HIP FIBERTAK ANCHORS EXHIBITED A FRAYED BLUE STITCH AFTER THE REPAIR SUTURE WAS SHUTTLED THROUGH THE ANCHOR. THE ANCHOR WAS STILL ABLE TO TENSION; HOWEVER, IT APPEARED AS THOUGH THERE WAS AN ADDITIONAL SUTURE THAT WAS FRAYED. THIS ISSUE OCCURRED WITH THREE CONSECUTIVE ANCHORS FROM THE SAME LOT. THE ISSUE WAS DISCOVERED DURING A HIP LABRUM REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 19-DEC-2025: THE ANCHORS REMAINED IMPLANTED IN THE PATIENT AS REMOVAL WAS UNSUCCESSFUL. ALL FRAYED SUTURE MATERIAL WAS REMOVED USING A SHAVER, LEAVING ONLY THE ANCHORS IN PLACE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT AR-3636H SELF-BUNCHING KNOTLESS 1.8 HIP FIBERTAK ANCHOR. THE CASE WAS DELAYED BY APPROXIMATELY 10 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23935892 ↗
• MalfunctionDec 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10-DEC-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT A QTY. 2 OF AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAKS HAD THE ANCHOR COME OUT OF THE BONE WHEN IT WAS CLOSED. THIS WAS DISCOVERED DURING USE WITH NO ADDITIONAL INFORMATION PROVIDED. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23934358 ↗
• MalfunctionDec 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT A QTY. 2 OF AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAKS HAD THE ANCHOR COME OUT OF THE BONE WHEN IT WAS CLOSED. THIS WAS DISCOVERED DURING USE WITH NO ADDITIONAL INFORMATION PROVIDED. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23934357 ↗
• MalfunctionDec 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10-DEC-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK ANCHOR CAME OUT OF THE BONE. THIS WAS DISCOVERED DURING USE WITH NO FURTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934234 ↗
• MalfunctionDec 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 11/24/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE LOOPED END OF THE SHUTTLE STITCH OF TWO AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHORS RIPPED OFF WHEN THE SURGEON ATTEMPTED TO CONVERT THE KNOTLESS MECHANISM. THE IMPLANT BODY WAS RETAINED IN THE PATIENT. THIS INCIDENT WAS DISCOVERED DURING A HIP LABRUM REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 12/01/2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 23778179 ↗
• MalfunctionDec 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 11/24/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE LOOPED END OF THE SHUTTLE STITCH OF TWO AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHORS RIPPED OFF WHEN THE SURGEON ATTEMPTED TO CONVERT THE KNOTLESS MECHANISM. THE IMPLANT BODY WAS RETAINED IN THE PATIENT. THIS INCIDENT WAS DISCOVERED DURING A HIP LABRUM REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 12/01/2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 23778032 ↗
• MalfunctionDec 8, 2025Break; Break

  ON NOVEMBER 17, 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT TWO AR-3636H SELF-BUNCHING KL 1.8 FIBERTAK SUTURES BROKE DURING A LABRAL REPAIR PROCEDURE. THE FIRST FIBERTAK HIP ANCHOR WAS PLACED FOLLOWING THE STANDARD SURGICAL TECHNIQUE. HOWEVER, WHEN TENSION WAS APPLIED TO THE SUTURE TO PERFORM THE KNOTLESS TECHNIQUE, THE SUTURE UNEXPECTEDLY BROKE. TO COMPLETE THE REPAIR, THE SURGEON REQUESTED A SECOND ANCHOR, BUT THE SAME ISSUE OCCURRED, THE SUTURE BROKE DURING TENSIONING DESPITE CORRECT HANDLING AND ADHERENCE TO THE RECOMMENDED PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743006 ↗