Arthrex® AR-3633SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867369962), received between Oct 12, 2023 and Aug 26, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Unraveled Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456200 ↗
• MalfunctionFeb 9, 2026Break

  ON 20-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3633SP FIBERTAK SP SUTURE ANCHOR EXPERIENCED AN ISSUE IN WHICH THE BLACK SUTURE TAPE BROKE WHILE THE SURGEON WAS TYING KNOTS AND USING THE KNOT PUSHER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 23-JAN-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24296036 ↗
• MalfunctionDec 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROXIMAL HAMSTRING ATTACHMENT SURGERY THE ANCHOR PULLED OUT WHEN THE SURGEON TRIED TO TIGHTEN THE SUTURES. IT WAS FURTHER CONFIRMED THAT THE SURGEON HAD DRILLED THE HOLE PRIOR TO INSERTION. 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 23818425 ↗
• MalfunctionNov 20, 2025Positioning Failure; Positioning Failure

  ON 10/31/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-3633SP FIBERTAK SELF-PUNCHING SUTURE ANCHOR DID NOT FIXATE DUE TO POOR BONE QUALITY DURING AN ARTHROSCOPY FOR THE REMOVAL OF CALCIFIC TENDINITIS. THE DOCTOR SUTURED THE ROTATOR CUFF USING INTRAOSSEOUS FIBERWIRE 5. NO PATIENT WAS AFFECTED. ADDITIONAL INFORMATION RECEIVED ON 11/07/25 FROM THE REP ADVISED THAT THE INSERTION DRILL FOR THE FIBERTAK ANCHOR WAS USED. IT DID NOT BREAK, AND NOTHING WAS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604575 ↗
• MalfunctionOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/24/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-3633SP SELF-PUNCHING TRIPLE-LOADED FIBERTAK ANCHOR BECAME UNUSABLE. AFTER THE ANCHOR WAS INSERTED INTO THE BONE HOLE, THE SUTURE CAME OUT WITHOUT ANY RESISTANCE WHEN PULLED. THE ANCHOR WAS SUBSEQUENTLY REMOVED, AND THE SURGERY WAS COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. THERE WAS NO SIGNIFICANT DELAY REPORTED, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439223 ↗
• MalfunctionSep 15, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  ON 08/25/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-3633SP FIBERTAK SP SUTURE ANCHOR HAD FAILED DURING USE. AFTER THE ANCHOR WAS INSERTED INTO THE BONE HOLE, IT WAS PULLED OUT WHEN TENSION WAS APPLIED TO THE TAPE. UPON INSPECTION, THE ANCHOR WAS FOUND TO BE BROKEN. THE SURGEON SUSPECTS THE ANCHOR MAY HAVE NOT BEEN PROPERLY SECURED TO THE SHAFT BEFORE INSERTION. THE PROCEDURE WAS PERFORMED ON (B)(6) 2025 AND WAS COMPLETED USING A REPLACEMENT AR-3633SP FIBERTAK SP SUTURE ANCHOR. NO FRAGMENTS REMAINED INSIDE THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED. THE SPECIFIC PROCEDURE TYPE REMAINS UNKNOWN, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051277 ↗
• MalfunctionAug 8, 2025Positioning Failure; Material Protrusion/Extrusion; Positioning Failure; Material Protrusion/Extrusion

  ON 07/23/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3633SP SELF-PUNCHING TRIPLE LOADED FIBERTAK STUCK OUT A LITTLE FROM THE BONE. THIS OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22751778 ↗
• MalfunctionAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/16/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3633SP FIBERTAK SP SUTURE ANCHOR WAS USED FOR THE MEDIAL ROW DURING A SUPRASPINATUS TENDON REPAIR ARTHROSCOPIC PROCEDURE ON (B)(6) 2025. THE ANCHOR PULLED OUT TWICE DURING PLACEMENT, EVEN AFTER BEING RELOADED AND REINSERTED INTO THE SAME HOLE IN AN ATTEMPT TO SET IT AGAIN. THE AR-3650DS DRILL WAS USED WITH THE ORANGE 3.5 REUSABLE DRILL GUIDE, AND THE ANCHOR WAS PLACED ACCORDING TO STANDARD TECHNIQUE. BONE QUALITY WAS MODERATE. AN AR-1927PST-3 ANCHOR WAS INSERTED IN THE SAME HOLE TO COMPLETE THE MEDIAL FIXATION. A 10-MINUTE DELAY OCCURRED. FOR THE LATERAL ROW, AN AR-2324KBCSP KNOTLESS BIOCOMPOSITE SWIVELOCK SP ANCHOR WAS USED, AND THE EYELET FRACTURED THROUGH THE SIDE UPON INSERTION. A TOTAL OF THREE SUTURE TAPES WERE LOADED INTO THE EYELET. THE HOLE WAS PRE-PUNCHED WITH THE SILVER PUNCH, AND LIGHT TAPS WERE USED TO INITIATE INSERTION. BONE QUALITY WAS MODERATE TO HARD. AN ADDITIONAL AR-2324KBCSP ANCHOR WAS USED TO COMPLETE THE LATERAL FIXATION. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2025: THE CASE WAS DELAYED A TOTAL OF TEN MINUTES DUE TO BOTH FAILED ANCHORS, WITH TEN MINUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720396 ↗
• MalfunctionJun 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 06/09/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-3641SP KNOTLESS 2.6 FIBERTAK SOFT ANCHOR AND AN AR-3633SP 2.6 FIBERTAK SP SOFT ANCHOR FAILED TO REMAIN IN PLACE AND BECAME LOOSE. THE PROCEDURE WAS COMPLETED USING REPLACEMENT ANCHORS OF THE SAME PRODUCT. THIS WAS DISCOVERED DURING A ROTATOR CUFF PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338579 ↗
• InjuryJan 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  UPDATE AVOE 08-JAN-2024: IT WAS FURTHER REPORTED THAT THE INITIAL BICEPS TENODESIS SURGERY WAS PERFORMED ON THE (B)(6) 2024 AND THE DEVICE AR-3633SP (LOT: 15298224) WAS IMPLANTED. THIS DEVICE TORE WITHIN ONE WEEK AFTER THE INITIAL SURGERY AND A REVISION BICEPS TENODESIS SURGERY WAS PERFORMED ON THE (B)(6) 2024. THE AFFECTED DEVICE WAS DISCARDED BY THE FACILITY. THIS DEVICE FAILURE WAS DOCUMENTED IN (B)(4). DURING THE REVISION SURGERY ON THE (B)(6) 2024 THE DEVICE AR-3633SP (LOT: 15301497) WAS IMPLANTED. THIS DEVICE ALSO TORE WITHIN ONE WEEK AFTER IT WAS IMPLANTED AND A SECOND REVISION BICEPS TENODESIS SURGERY WAS REQUIRED, WHICH WAS PERFORMED ON THE (B)(6) 2024. THIS DEVICE WILL BE RETURNED FOR INVESTIGATION AND THE CASE WAS DOCUMENTED IN (B)(4). DURING THIS REVISION THE PATIENT WAS TREATED WITH AN AR-1662BC DEVICE. UPDATE AVOE 30-JAN-2024: IT WAS FURTHER REPORTED THAT THE PATIENT FOLLOWED THE POST-OP ROUTINE IN BOTH CASES. THE HOSPITAL'S SCHEME DOES NOT PROVIDE FOR A BRACE. AFTER THE FIRST OPERATION, THE ANCHOR TORE DURING THE INPATIENT STAY APPROX. 2 DAYS AFTER THE OPERATION WITHOUT ANY VISIBLE EFFECT. AFTER THE SECOND OPERATION, THE PATIENT GOT AND WORE A BRACE AT HIS OWN REQUES

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21100854 ↗
• MalfunctionJan 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  UPDATE AVOE 08-JAN-2024 IT WAS FURTHER REPORTED THAT THE INITIAL BICEPS TENODESIS SURGERY WAS PERFORMED ON THE (B)(6) 2024 AND THE DEVICE AR-3633SP (LOT: 15298224) WAS IMPLANTED. THIS DEVICE TORE WITHIN ONE WEEK AFTER THE INITIAL SURGERY AND A REVISION BICEPS TENODESIS SURGERY WAS PERFORMED ON THE (B)(6) 2024. THE AFFECTED DEVICE WAS DISCARDED BY THE FACILITY. THIS DEVICE FAILURE WAS DOCUMENTED IN (B)(4). DURING THE REVISION SURGERY ON THE (B)(6) 2024 THE DEVICE AR-3633SP (LOT: 15301497) WAS IMPLANTED. THIS DEVICE ALSO TORE WITHIN ONE WEEK AFTER IT WAS IMPLANTED AND A SECOND REVISION BICEPS TENODESIS SURGERY WAS REQUIRED, WHICH WAS PERFORMED ON THE (B)(6) 2024. THIS DEVICE WILL BE RETURNED FOR INVESTIGATION AND THE CASE WAS DOCUMENTED IN (B)(4). DURING THIS REVISION THE PATIENT WAS TREATED WITH AN AR-1662BC DEVICE. UPDATE AVOE 30-JAN-2024: IT WAS FURTHER REPORTED THAT THE PATIENT FOLLOWED THE POST-OP ROUTINE IN BOTH CASES. THE HOSPITAL'S SCHEME DOES NOT PROVIDE FOR A BRACE. AFTER THE FIRST OPERATION, THE ANCHOR TORE DURING THE INPATIENT STAY APPROX. 2 DAYS AFTER THE OPERATION WITHOUT ANY VISIBLE EFFECT. AFTER THE SECOND OPERATION, THE PATIENT GOT AND WORE A BRACE AT HIS OWN REQUEST

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21100785 ↗
• InjuryOct 29, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A PATIENT VIA PHONE THAT SHE WAS EXPERIENCING PAIN AND INFLAMMATION POST-OPERATIVELY AND INQUIRED ABOUT THE MATERIAL COMPOSITION OF SEVERAL KNOWN AND UNKNOWN ARTHREX PRODUCTS. DURING AN INITIAL ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, QTY. 2 OF AN AR-2324BCM SUTURE ANCHOR, BIO-COMPOSITE SWIVELOCK SP, AN AR-3633SP FIBERTAK SP SUTURE ANCHOR, AND AN AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM WERE IMPLANTED. AFTER 6 WEEKS POST-OP, THE PATIENT EXPERIENCED INCREASING PAIN AND INFLAMMATION, BUT THE INITIAL SURGEON DID NOT WANT TO PERFORM REVISION SURGERY AND STATED THAT NOTHING WAS WRONG. THE PATIENT THEN WENT TO ANOTHER SURGEON WHO PERFORMED REVISION SURGERY ON THE RIGHT SHOULDER ON (B)(6) 2024. IT WAS FOUND THAT THE SUTURES TO ONE OF THE ANCHORS WERE LOOSE; NOTHING HAD BROKEN INSIDE THE PATIENT. THE SURGEON CUT THE LOOSE SUTURES AND REMOVED THEM, BUT THE ANCHOR AND ALL OTHER DEVICES FROM THE INITIAL SURGERY REMAINED INSIDE THE PATIENT. DURING THE ADDITIONAL PROCEDURE, ADDITIONAL UNKNOWN ARTHREX SUTURE ANCHORS, SWIVELOCK ANCHORS, AND A GRAFT WERE IMPLANTED USING THE ARTHREX CUFFMEND SYSTEM. AFTER THE ADDITIONAL SURGERY, THE PATIENT EXPERIENCED PAIN AND

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20560506 ↗
• MalfunctionOct 17, 2024Break; Break

  ON 10/14/2024 ADDITIONAL INFORMATION WAS PROVIDED BY THE SALE REP VIA EMAIL WHO STATED THAT THE DEVICE USED TO PREPARE THE BONE WAS A DRILL AND GUIDE AND THAT THE PATIENT'S BONE QUALITY WAS VERY HARD.

  Patient problems: Foreign Body In Patient

  MAUDE report 20469650 ↗
• MalfunctionSep 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08/16/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3633SP FIBERTAK SP PULLED OUT OF THE BONE. THE PATIENT WAS NOT AFFECTED, AND THE CASE WAS NOT DELAYED. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162318 ↗
• MalfunctionJun 7, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS SURGERY THE ANCHOR DID NOT RELEASE DURING INSERTION. 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 19488839 ↗
• MalfunctionMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/03/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT A AR-3633SP FIBERTAK BACKED OUT. THIS OCCURRED ON (B)(6) 2021 DURING A QUADRICEPS TENDON REPAIR WHEN THE FIBERTAK DRILLED THROUGH THE DRILL GUIDE TO A HARD STOP IN THE MEDIAL THIRD OF THE SUPERIOR PATELLAR POLE. THE ANCHOR WAS IMPACTED TO THE MIDPOINT OF THE LONG LASER LINE. THE SUTURE RELEASE TAB WAS REMOVED AS WELL AS THE INSERTER. THE SURGEON BEGAN TO PULL ALL SIX SUTURE LIMBS OUT AND THE ANCHOR IMMEDIATELY BACKED OUT FROM THE BONE. THE ANCHOR WAS RELOADED, REINSERTED INTO THE BONE APPROXIMATELY TO THE MIDPOINT OF THE LONG LASER LINE, INSERTER WAS REMOVED AGAIN, AND ONCE AGAIN THE ANCHOR BACKED OUT. THESE EXACT STEPS WERE TAKEN A THIRD TIME AND ONCE MORE THE SAME RESULT OF THE ANCHOR BACKING OUT. THE CASE WAS COMPLETED WITH A NEW HOLE BEING DRILLED, AND A NEW ANCHOR WAS OPENED AND INSERTED WITHOUT ANY ISSUES. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19278405 ↗
• MalfunctionMay 9, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 04/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-3633SP FIBERTAK® SP SUTURE ANCHORS FAILED. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2024 THE FIRST DEVICE WAS USED AND THE BONE HAD BEEN PREPPED USING THE SELFPUNCH AND THE DEVICE BENT DURING INSERTION. THE DEVICE WAS REMOVED AND THE SECOND ONE WAS BROUGHT IN A PUNCH WAS USED TO PUNCH THE WHOLE AND THE DEVICE ENDED UP PULLING OUT. THE CASE WAS COMPLETED USING AN AR-1927BCF-3 5.5 MM BIOCOMPOSITE CORKSCREW.

  Patient problems: Insufficient Information

  MAUDE report 19277373 ↗
• MalfunctionMay 9, 2024Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  ON 04/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-3633SP FIBERTAK® SP SUTURE ANCHORS FAILED. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2024 THE FIRST DEVICE WAS USED AND THE BONE HAD BEEN PREPPED USING THE SELFPUNCH AND THE DEVICE BENT DURING INSERTION. THE DEVICE WAS REMOVED AND THE SECOND ONE WAS BROUGHT IN A PUNCH WAS USED TO PUNCH THE WHOLE AND THE DEVICE ENDED UP PULLING OUT. THE CASE WAS COMPLETED USING AN AR-1927BCF-3 5.5 MM BIOCOMPOSITE CORKSCREW.

  Patient problems: Insufficient Information

  MAUDE report 19277161 ↗
• MalfunctionMay 8, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS SURGERY THE ANCHOR DID NOT RELEASE DURING INSERTION. 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 19267306 ↗
• MalfunctionMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-3633SP FIBERTAK UNRAVELED AND BACKED OUT. THIS OCCURRED ON (B)(6) 2022 DURING A ROTATOR CUFF REPAIR AFTER THE ANCHOR WAS INSERTED, IT UNRAVELED AND BACKED OUT. THE CASE WAS COMPLETED USING A 4.75 MM SWIVELOCK AND THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19251583 ↗
• MalfunctionMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/10/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-3633SP ANCHOR PULLED OUT WHILE USING THE AR-3650DS SLEEVE AFTER INSERTION DURING A ROTATOR CUFF REPAIR. TWO SIDE BY SIDE SPEED FIXES WERE USED TO COMPLETE THE CASE. THE REP STATED THE BONE WAS SOFT AND POOR CAUSING THE ISSUE. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249948 ↗
• MalfunctionApr 24, 2024Defective Device; Defective Device

  ON 03/28/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-3633SP FIBERTAK SP FAILED DURING INSERTION. THE CASE WAS COMPLETED USING AN AR-1928SF-3 CORKSCREW FT III. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19172387 ↗
• MalfunctionFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 02/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3633SP FIBERTAK ANCHOR PULLED OUT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. "PATIENT DID NOT HAVE EXCESSIVELY HARD BONE SO WE USED THE SELF PUNCHING MECHANISM TO INSERT THE ANCHOR. THE ANCHOR PULLED OUT. WE HAD TO USED A 4.75 ANCHOR TO FILL THE BONE SOCKET AND COMPLETE THE REPAIR. THE CASE WAS ONLY DELAYED A COUPLE MINUTES AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789956 ↗
• MalfunctionOct 12, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 9/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3633SP FIBERTAK SP SUTURE ANCHOR HAD AN ISSUE DURING A PECTORALIS REPAIR PROCEDURE ON (B)(6)2023. THEY DRILLED INTO THE HUMERUS WITH THE 2.6 FT KIT AND INSERTED THE 2.6 FT (AR-3633SP FIBERTAK SP SUTURE ANCHOR). WHILE INSERTING THE 2.6 FT, THE BUNCHING MECHANISM WAS CUT IN HALF. THEY PULLED THE ANCHOR OUT AND PUT IN A NEW ONE. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/13/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION: THE HUMERUS WAS DRILLED WITH AN AR-3650DS FIBERTAK RC DISPOSABLES KIT WITH AN UNKNOWN LOT NUMBER. WHEN THE BUNCHING MECHANISM WAS CUT, ALL SUTURE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE ANCHOR WAS PULLED OUT, AND ALL ANCHOR FRAGMENTS WERE REMOVED. A DRILL KIT WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION. THE BONE QUALITY OF THE PATIENT WAS GOOD. ANOTHER 2 AR-3633SP FIBERTAK SP SUTURE ANCHORS WITH AN UNKNOWN LOT NUMBER WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO CASE DELAY REPORTED, AS THEY USED THE SAME HOLE FOR THE SECOND ANCHOR WITHOUT ANY ISSUES. THE DEVICE WAS DISCARDED BY THE FACILITY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921258 ↗