Arthrex® AR-3638HRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00888867295568), received between Jun 23, 2020 and Sep 10, 2025 — classified as 12 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 08/21/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-3638H KNOTLESS HIP FIBERTAK SUTURE ANCHOR EXPERIENCED AN ISSUE IN WHICH THE REPAIR SUTURE BREAKS FROM THE ANCHOR DURING PASSAGE. THE CASE WAS COMPLETED WITH ANOTHER NEW IMPLANT. THIS WAS DISCOVERED DURING A HIP INSTABILITY PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/27/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018640 ↗
• MalfunctionJun 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 4/7/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-3638H KNOTLESS HIP FIBERTAK PASSING STITCH RIPPED AND PULLED BOTH ANCHORS OUT OF IMPLANTATION SITE. THIS OCCURRED CONSECUTIVELY DURING A HIP LABRAL REPAIR ON (B)(6) 2022. CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED 4/7/2022: SURGEON REMOVED ALL BROKEN SUTURES FROM INSIDE THE PATIENT AND USED ANOTHER AR-3638H KNOTLESS HIP FIBERTAK TO COMPLETE THE CASE WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536902 ↗
• MalfunctionJun 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H KNOTLESS HIP FIBERTAK PULLED OUT MULTIPLE TIMES. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(60 2023. ADDITIONAL INFORMATION RECEIVED ON 3/31/2023: NOTHING BROKE INSIDE THE PATIENT AND THE CASE WAS COMPLETED WITH A PRODUCT FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521211 ↗
• MalfunctionJun 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON 08/12/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H FIBERTAK BUNCHED UP ON INSERTION AND SHREDDED THE REPAIR STITCH. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484160 ↗
• MalfunctionJun 5, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED ON 08/11/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H FIBERTAK SUTURE WOULD NOT CINCH DOWN. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472846 ↗
• MalfunctionJun 5, 2024Failure to Advance; Failure to Advance

  ON 7/19/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H KNOTLESS HIP FIBERTAK ANCHOR WOULD NOT TENSION ALL THE WAY DOWN AND LEFT ACCESS SUTURE AROUND THE LABRUM. SURGEON OPENED ANOTHER AR-3638H KNOTLESS HIP FIBERTAK AND THE SAME THING HAPPENED. CASE WAS COMPLETED BY CUTTING THE SUTURES AND PLACING TWO MORE AR-3638H ANCHORS FROM A LOT NUMBER. THIS WAS DISCOVERED DURING A HIP SCOPE WITH LABRAL REPAIR PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472726 ↗
• MalfunctionJun 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 03/25/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA PHONE THAT A AR-3638H FIBERTAK ANCHOR WOULD NOT FIXATE. THIS OCCURRED ON (B)(6) 2022 DURING A HIP LABRAL REPAIR WHEN THE ANCHOR WAS ATTEMPTED TO BE IMPLANTED. THEY WERE UNABLE TO GET FIXATION, IT WAS ATTEMPTED IN MULTIPLE DIFFERENT POSITIONS. THE TEAM SWITCHED TO ANOTHER AR-3638H AND THE CASE WAS COMPLETED WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444337 ↗
• MalfunctionJun 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 1/20/2022 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3638H IMPLANT WOULD NOT WORK AND WAS PULLING OUT DURING A CASE. NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441811 ↗
• MalfunctionMay 24, 2024Defective Device; Defective Device

  ON 06/03/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (4) AR-3638H FIBERTAKS FAILED. THIS OCCURRED ON (B)(6) 2022 DURING A HIP ARTHROSCOPIC PROCEDURE. THE AR-3638H FIBERTAK (LINE 1) SUTURE TORE AFTER THE IMPLANT WAS IMPLANTED INTO THE PATIENT. THEN A SECOND AR-3638H FIBERTAK (LINE 2) WAS OPENED AND A KNOT WAS NOTICED AND WAS NOT USED. A THIRD AR-3638H FIBERTAK (LINE 3) WAS OPENED AND THE SAME ISSUE OCCURRED. A FOURTH AR-3638H FIBERTAK (LINE 4) WAS THEN OPENED AND A KNOT WAS NOTICED, BUT WAS USED BY THE SURGEON. THE CASE WAS COMPLETED BY USING A FIFTH AR-3638H FIBERTAK (LINE 5) WITH NO FURTHER ISSUES AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392058 ↗
• MalfunctionMay 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 06/03/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (4) AR-3638H FIBERTAKS FAILED. THIS OCCURRED ON (B)(6) 2022 DURING A HIP ARTHROSCOPIC PROCEDURE. THE AR-3638H FIBERTAK (LINE 1) SUTURE TORE AFTER THE IMPLANT WAS IMPLANTED INTO THE PATIENT. THEN A SECOND AR-3638H FIBERTAK (LINE 2) WAS OPENED AND A KNOT WAS NOTICED AND WAS NOT USED. A THIRD AR-3638H FIBERTAK (LINE 3) WAS OPENED AND THE SAME ISSUE OCCURRED. A FOURTH AR-3638H FIBERTAK (LINE 4) WAS THEN OPENED AND A KNOT WAS NOTICED, BUT WAS USED BY THE SURGEON. THE CASE WAS COMPLETED BY USING A FIFTH AR-3638H FIBERTAK (LINE 5) WITH NO FURTHER ISSUES AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391757 ↗
• MalfunctionMay 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON 07/14/2022 BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-3638H KNOTLESS FIBERTAK ANCHOR WOULD PULL OUT DURING TENSION. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350924 ↗
• MalfunctionMay 14, 2024Break; Break

  IT WAS REPORTED THAT THE REPAIR STITCH BROKE WHEN SHUTTLING THE IT BACK THRU THE ANCHOR. THE CONSTRUCT WAS REMOVED AND ANOTHER AR-3638H WAS USED TO COMPLETE THE HIP LABRAL REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 19310764 ↗
• MalfunctionMay 13, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON 11/09/2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3638H FIBERTAK TIP BENT AND ANOTHER BROKE OFF. CASE INVOLVEMENT, BROKE INSIDE JOINT SPACE.

  Patient problems: Insufficient Information

  MAUDE report 19297839 ↗
• MalfunctionMay 2, 2024Fitting Problem; Fitting Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA PHONE THAT A AR-3638H FIBERTAK ANCHOR WOULD NOT FIXATE. THIS OCCURRED ON (B)(6) 2022 DURING A HIP LABRAL REPAIR WHEN THE ANCHOR WAS ATTEMPTED TO BE IMPLANTED. THEY WERE UNABLE TO GET FIXATION, IT WAS ATTEMPTED IN MULTIPLE DIFFERENT POSITIONS. THE TEAM SWITCHED TO ANOTHER AR-3638H AND THE CASE WAS COMPLETED WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230692 ↗
• MalfunctionApr 16, 2024Defective Device; Defective Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-3638H FIBERTAKS SUTURES DID NOT SHUTTLE PROPERLY. THIS OCCURRED ON (B)6) 2022 DURING A HIP SCOPE WHEN THE SUTURES WOULD NOT SHUTTLE PROPERLY AND THE SURGEON DECLARED THE ANCHOR UNUSABLE. NO FRAGMENTS WERE CREATED, THE DEVICE WAS REMOVED AND THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE OF THE SAME PART NUMBER. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115587 ↗
• MalfunctionJan 5, 2024Break; Break

  ON 5/9/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H KNOTLESS HIP FIBERTAK SUTURE BROKE WHILE PASSING AND TENSIONING. SURGEON OPENED A SECOND KNOTLESS HIP FIBERTAK AND THE SAME THING HAPPENED. FINALLY, CASE WAS COMPLETED USING A THIRD KNOTLESS HIP FIBERTAK FROM A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2022. NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18452017 ↗
• MalfunctionJan 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE SUTURE TORE OFF BEFORE THE SHUTTLING OF THE SUTURE EVEN STARTED. PARTS OF THE DEVICE 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: Foreign Body In Patient

  MAUDE report 18444092 ↗
• MalfunctionAug 24, 2023Material Frayed; Material Frayed

  ON 07/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3638H KNOTLESS HIP FIBERTAK SUTURE ANCHOR HAD AN ISSUE. DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2023, A 1.8 KNOTLESS HIP FIBERTAK WAS INSERTED USING STANDARD TECHNIQUE UTILIZING A MID-ANTERIOR HIP PORTAL. AFTER THE INSERTION OF THE ANCHOR, THE INSERTER WAS REMOVED. ONCE THE INSERTER WAS REMOVED, IT APPEARED THAT THE PASSING STITCH IN THE ANCHOR WAS FRAYED APART ON THE LINK SIDE OF THE SUTURE. THEY COULD NOT CONCLUDE THAT THIS PASSING STITCH WAS COMPROMISED ON INSERTION. THEY ATTEMPTED TO USE THE ANCHOR AS NORMAL, BUT THE PASSING STITCH BROKE WHILE SHUTTLING THE REPAIR STITCH. THE SUTURES HAD TO BE CUT OUT. THE IMPLANT STAYED IN THE PATIENT, ONLY THE SUTURES WERE REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED. ON 8/3/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: AN ADDITIONAL AR-3638H KNOTLESS HIP FIBERTAK SUTURE ANCHOR WITH AN UNKNOWN LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THE BONE QUALITY OF THE PATIENT WAS NOT PROVIDED. THERE WERE NO ADVERSE EFFECTS AND NO CASE DELAY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612579 ↗
• InjuryMay 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6)2023, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT (3) ARTHREX 3.0MM KNOTLESS ALL SUTURE ANCHORS WITH #2 FIBERWIRE SUTURES WERE IMPLANTED DURING A RIGHT HIP FAI PROCEDURE ON (B)(6)2021. THEN, ON (B)(6)2022, THE PATIENT UNDERWENT ANOTHER PROCEDURE FOR A RIGHT HIP FAI IN WHICH AN ARTHREX 2.4MM PEEK PUSHLOCK ANCHORS WITH #2 FIBERWIRE SUTURES AND (6) ARTHREX 1.8MM KNOTLESS ALL SUTURE ANCHORS WITH #2 FIBERWIRE SUTURES WAS IMPLANTED. THE PATIENT IS NOW EXPERIENCING AN ALLERGIC REACTION. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 5/5/2023: THE PROCEDURE ON (B)(6)2021 WAS A RIGHT HIP ARTHROSCOPY, LABRAL REPAIR, FEMOROPLASTY, ACETABULOPLASTY, CAPSULECTOMY, SYNOVECTOMY, CHONDROPLASTY, ILIOPSOAS BURSECTOMY, INJECTION, AND ASPIRATION. A TOTAL OF FOUR AR-3638H KNOTLESS HIP FIBERTAK WERE IMPLANTED. SHORTLY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ONGOING PAIN WITH NO RELIEF OF DISCOMFORT, WHICH LED TO SEEKING AN OPINION FROM AN IMMUNOLOGIST. AN ALLERGY PATCH TEST WAS CONDUCTED, AND IT CONFIRMED POSITIVE FOR SEVERAL METALS AND MATERIALS. THE PATIENT WAS NOT TREATED FOR A POSSIBLE ALLERGIC REACTION, AS THE MATERIAL COMPOSITION FOR THE ARTHREX DEVICE

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17014526 ↗
• InjuryMay 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6)2023, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT (3) ARTHREX 3.0MM KNOTLESS ALL SUTURE ANCHORS WITH #2 FIBERWIRE SUTURES WERE IMPLANTED DURING A RIGHT HIP FAI PROCEDURE ON (B)(6)2021. THEN, ON (B)(6)2022, THE PATIENT UNDERWENT ANOTHER PROCEDURE FOR A RIGHT HIP FAI IN WHICH AN ARTHREX 2.4MM PEEK PUSHLOCK ANCHORS WITH #2 FIBERWIRE SUTURES AND (6) ARTHREX 1.8MM KNOTLESS ALL SUTURE ANCHORS WITH #2 FIBERWIRE SUTURES WAS IMPLANTED. THE PATIENT IS NOW EXPERIENCING AN ALLERGIC REACTION. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 5/5/2023: THE PROCEDURE ON (B)(6)2021 WAS A RIGHT HIP ARTHROSCOPY, LABRAL REPAIR, FEMOROPLASTY, ACETABULOPLASTY, CAPSULECTOMY, SYNOVECTOMY, CHONDROPLASTY, ILIOPSOAS BURSECTOMY, INJECTION, AND ASPIRATION. A TOTAL OF FOUR AR-3638H KNOTLESS HIP FIBERTAK WERE IMPLANTED. SHORTLY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ONGOING PAIN WITH NO RELIEF OF DISCOMFORT, WHICH LED TO SEEKING AN OPINION FROM AN IMMUNOLOGIST. AN ALLERGY PATCH TEST WAS CONDUCTED, AND IT CONFIRMED POSITIVE FOR SEVERAL METALS AND MATERIALS. THE PATIENT WAS NOT TREATED FOR A POSSIBLE ALLERGIC REACTION, AS THE MATERIAL COMPOSITION FOR THE ARTHREX DEVICE

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17014478 ↗
• InjuryMay 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6)2023, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT (3) ARTHREX 3.0MM KNOTLESS ALL SUTURE ANCHORS WITH #2 FIBERWIRE SUTURES WERE IMPLANTED DURING A RIGHT HIP FAI PROCEDURE ON (B)(6)2021. THEN, ON (B)(6)2022, THE PATIENT UNDERWENT ANOTHER PROCEDURE FOR A RIGHT HIP FAI IN WHICH AN ARTHREX 2.4MM PEEK PUSHLOCK ANCHORS WITH #2 FIBERWIRE SUTURES AND (6) ARTHREX 1.8MM KNOTLESS ALL SUTURE ANCHORS WITH #2 FIBERWIRE SUTURES WAS IMPLANTED. THE PATIENT IS NOW EXPERIENCING AN ALLERGIC REACTION. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 5/5/2023: THE PROCEDURE ON (B)(6)2021 WAS A RIGHT HIP ARTHROSCOPY, LABRAL REPAIR, FEMOROPLASTY, ACETABULOPLASTY, CAPSULECTOMY, SYNOVECTOMY, CHONDROPLASTY, ILIOPSOAS BURSECTOMY, INJECTION, AND ASPIRATION. A TOTAL OF FOUR AR-3638H KNOTLESS HIP FIBERTAK WERE IMPLANTED. SHORTLY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ONGOING PAIN WITH NO RELIEF OF DISCOMFORT, WHICH LED TO SEEKING AN OPINION FROM AN IMMUNOLOGIST. AN ALLERGY PATCH TEST WAS CONDUCTED, AND IT CONFIRMED POSITIVE FOR SEVERAL METALS AND MATERIALS. THE PATIENT WAS NOT TREATED FOR A POSSIBLE ALLERGIC REACTION, AS THE MATERIAL COMPOSITION FOR THE ARTHREX DEVICE

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17014474 ↗
• InjuryFeb 17, 2023Break; Material Fragmentation

  ON 1/23/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3638H KNOTLESS HIP FIBERTAK HAD AN ISSUE. DURING A LEFT HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2021, TWO AR-3638H KNOTLESS HIP FIBERTAK IMPLANTS WERE OPENED, AND ONLY ONE OF THEM WAS IMPLANTED SUCCESSFULLY. UPON USING THE SECOND IMPLANT, THE DRILL GUIDE WAS USED TO DRILL A HOLE AND THE IMPLANT WAS MALLETED IN THE BONE TUNNEL THAT WAS PREPARED. WHEN MALLETING THE IMPLANT, IT RESISTED, SO THEY REMOVED THE IMPLANT AND NOTICED THAT THE TIP OF THE INSERTER HAD BROKEN OFF INSIDE THE PATIENT. THEY WERE NOT ABLE TO REMOVE THE BROKEN TIP. THE SURGEON DEEMED IT SAFE TO LEAVE IT INSIDE THE PATIENT, AS IT WAS DEEP IN THE BONE TUNNEL, AND NO MATTER WAS EXPOSED. THE TIP OF THE INSERTER STAYED CONTAINED WITHIN THE BONE TUNNEL. THE SECOND IMPLANT WAS REMOVED AND DISCARDED. THE SALES REPRESENTATIVE WAS NOT SURE WHICH OF THE TWO LOT NUMBERS WAS THE COMPLAINT DEVICE THAT MALFUNCTIONED. A PICTURE OF THE COMPLAINT DEVICE WILL BE PROVIDED VIA EMAIL. ADDITIONAL INFORMATION RECEIVED ON 2/2/2023: PER THE PATIENT REPORTING, SINCE THE AR-3638H KNOTLESS HIP FIBERTAK INSERTER TIP BROKE AND COULD NOT BE REMOVED, THE PIECE HAD TO BE SHAV

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 16395539 ↗
• InjuryFeb 17, 2023Break

  ON 1/23/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3638H KNOTLESS HIP FIBERTAK HAD AN ISSUE. DURING A LEFT HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2021, TWO AR-3638H KNOTLESS HIP FIBERTAK IMPLANTS WERE OPENED, AND ONLY ONE OF THEM WAS IMPLANTED SUCCESSFULLY. UPON USING THE SECOND IMPLANT, THE DRILL GUIDE WAS USED TO DRILL A HOLE AND THE IMPLANT WAS MALLETED IN THE BONE TUNNEL THAT WAS PREPARED. WHEN MALLETING THE IMPLANT, IT RESISTED, SO THEY REMOVED THE IMPLANT AND NOTICED THAT THE TIP OF THE INSERTER HAD BROKEN OFF INSIDE THE PATIENT. THEY WERE NOT ABLE TO REMOVE THE BROKEN TIP. THE SURGEON DEEMED IT SAFE TO LEAVE IT INSIDE THE PATIENT, AS IT WAS DEEP IN THE BONE TUNNEL, AND NO MATTER WAS EXPOSED. THE TIP OF THE INSERTER STAYED CONTAINED WITHIN THE BONE TUNNEL. THE SECOND IMPLANT WAS REMOVED AND DISCARDED. THE SALES REPRESENTATIVE WAS NOT SURE WHICH OF THE TWO LOT NUMBERS WAS THE COMPLAINT DEVICE THAT MALFUNCTIONED. A PICTURE OF THE COMPLAINT DEVICE WILL BE PROVIDED VIA EMAIL. ADDITIONAL INFORMATION RECEIVED ON 2/2/2023: PER THE PATIENT REPORTING, SINCE THE AR-3638H KNOTLESS HIP FIBERTAK INSERTER TIP BROKE AND COULD NOT BE REMOVED, THE PIECE HAD TO BE SHAV

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 16395517 ↗
• InjuryDec 27, 2022Output Problem; Positioning Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (4) AR-3638H KNOTLESS HIP FIBERTAK ANCHOR WOULD NOT SEAT AS THE SURGEON WAS TENSIONING THE CONSTRUCT AND WOULD PULL OUT. SURGEON SPENT 45 MINUTES CONSTANTLY TRYING TO IMPLANT ANCHORS WITH NO SUCCESS. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 12/5/2022: DUE TO THE 45 MINUTES DELAY, PATIENT WAS ADMINISTERED ADDITIONAL ANESTHESIA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16050728 ↗
• InjuryDec 27, 2022Output Problem; Positioning Problem

  ON 10/31/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (4) AR-3638H KNOTLESS HIP FIBERTAK ANCHOR WOULD NOT SEAT AS THE SURGEON WAS TENSIONING THE CONSTRUCT AND WOULD PULL OUT. SURGEON SPENT 45 MINUTES CONSTANTLY TRYING TO IMPLANT ANCHORS WITH NO SUCCESS. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 12/5/2022: DUE TO THE 45 MINUTES DELAY, PATIENT WAS ADMINISTERED ADDITIONAL ANESTHESIA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16050723 ↗