Arthrex® AR-1938BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00888867097186), received between Dec 7, 2016 and Aug 29, 2025 — classified as 9 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (15 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.

• MalfunctionAug 29, 2025Crack; Crack

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1938BC KNOTLESS BIOCOMPOSITE SUTURETAK ANCHOR CRACKED WHEN BEING INSERTED INTO THE BONE HOLE. THE SURGERY WAS COMPLETED USING A REPLACEMENT AR-1938BC KNOTLESS BIOCOMPOSITE SUTURETAK ANCHOR. NO ADVERSE EFFECTS WERE REPORTED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 8/19/2025: THE BROKEN FRAGMENTS WERE NOT REMOVED. THE CASE DID NOT EXPERIENCE A DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. ADDITIONAL INFORMATION WAS RECEIVED ON 08/22/2025: ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921941 ↗
• MalfunctionJun 26, 2025Break; Break

  ON 5 JUNE 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE THAT AR-1938BC SUTURE ANCHOR, BIOCOMPOSITE SUTURETAK®, KNOTLESS WITH #2 SUTURE. BROKE DURING USE. THIS WAS DISCOVERED DURING A MEDIAL PATELLOFEMORAL LIGAMENT (MPFL) PROCEDURE. THE SUTURES ANCHOR AFTER IMPLANTING INTO THE BONE BUT THE SUTURES WERE NOT SLIDING WELL AND THEN BROKE OFF. THE BROKEN IMPLANT IS LEFT IN THE PATIENT. ANOTHER ANCHOR WAS RE-INSERTED AND THE SUTURES FROM THE PREVIOUS ANCHOR WAS CUFF OFF. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22337306 ↗
• MalfunctionDec 30, 2024Break; Break

  ON 12/3/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1938BC BIOCOMPOSITE SUTURETAK ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING AN ELBOW UCL REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING ANOTHER AR-1938BC BIOCOMPOSITE SUTURETAK ANCHOR. ADDITIONAL INFORMATION RECEIVED ON 12/13/2024: THE ANCHOR BROKE OUTSIDE THE PATIENT, SO THERE ARE NO ANCHOR FRAGMENTS INSIDE THE PATIENT. THE CASE WAS NOT DELAYED.

  Patient problems: Insufficient Information

  MAUDE report 21035180 ↗
• MalfunctionAug 26, 2024Break; Break

  ADDITIONAL INFORMATION WAS PROVIDED ON 08/07/2024 WHERE IT WAS STATED THE DEVICE BROKE WHEN THE SURGEON WENT TO IMPACT THE ANCHOR, AS IT WAS A TISSUE ANCHOR THERE WAS NO FRAGMENT LEFT IN THE PATIENT. BEFORE PLACING THE ANCHOR, THE DOCTOR ALWAYS PREPARES THE LABRUM USING A SHAVER BLADE AND A DECOLLETIZER. THE PATIENT WAS YOUNG AND A PLAYER, SO THE BONE QUALITY WAS PROBABLY EXCELLENT."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066243 ↗
• MalfunctionJul 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/03/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS- (B)(4) THAT AN AR-1938BC SUTURE ANCHOR, BIOCOMPOSITE SUTURETAK ANCHOR CAME OUT IN ONE PIECE WHEN THE SURGEON TESTED TO SEE IF IT WAS FIXED AFTER CARRYING OUT THE STEP-BY-STEP PROCEDURE FOR ANCHOR INSERTION. EVERYTHING WAS REMOVED FROM THE PATIENT. THE SURGEON THEN USED THE PUSHLOCK ANCHOR TO REPAIR THE LABRUM. THIS WAS DISCOVERED DURING A BILATERAL HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793813 ↗
• MalfunctionJan 26, 2024Break; Break

  ON 01/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT 2X AR-1938BC SUTURE ANCHOR KNOTLESS ANCHOR BROKE UPON INSERTION. ALL FRAGMENTS REMOVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED USING ADDITIONAL AR-1938BC ANCHORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587563 ↗
• MalfunctionJan 26, 2024Break; Break

  ON 01/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT 2X AR-1938BC SUTURE ANCHOR KNOTLESS ANCHOR BROKE UPON INSERTION. ALL FRAGMENTS REMOVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED USING ADDITIONAL AR-1938BC ANCHORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587554 ↗
• MalfunctionDec 8, 2023Material Frayed; Material Frayed

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT QTY. 3 OF AN AR-3636 FIBERTAK RC SUTURE ANCHOR AND AN AR-1938BC SUTURE ANCHOR HAD AN ISSUE DURING AN ANTERIOR LABRAL REPAIR REVISION SURGERY TO REMOVE NON-ARTHREX PRODUCTS ON 11/14/2023. WHEN THE FIRST TWO AR-3636 FIBERTAK RC SUTURE ANCHORS WERE INSERTED, IT WAS NOTICED THAT THE SHUTTLE SUTURE WAS FRAYED BEFORE SHUTTLING. THE SUTURES WERE CUT AND REMOVED, AND BOTH ANCHORS WERE REMOVED IN ONE PIECE; NO PIECE OF THE ANCHORS BROKE INSIDE THE PATIENT. ANOTHER AR-3636 FIBERTAK RC SUTURE ANCHOR WAS OPENED, BUT THE INSERTER WAS BENT STRAIGHT OUT OF THE PACKAGE AND, THEREFORE, COULD NOT BE USED IN THE PROCEDURE. AN AR-1938BC SUTURE ANCHOR WAS ALSO USED, AND THE SHUTTLING SUTURE WAS FRAYED AFTER BEING INSERTED INTO THE PATIENT. THOSE SUTURES WERE CUT AND REMOVED, AND THE AR-1938BC SUTURE ANCHOR WAS REMOVED IN ONE PIECE FROM THE PATIENT; NO PIECE OF THE ANCHOR BROKE. ALL FOUR COMPLAINT DEVICES WERE DISCARDED, AND NO CASE PICTURES WERE TAKEN. FIVE NEW AR-3636 FIBERTAK RC SUTURE ANCHORS (TWO WITH LOT NUMBER 15109221 AND THREE WITH LOT NUMBER 15129639) AND ONE AR-1926BC SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK (WITH LOT NUMBE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291984 ↗
• MalfunctionNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-3636 KNOTLESS FIBERTAK AND AN AR-1938BC KNOTLESS BIOCOMPOSITE SUTURETAK PULLED OUT OF IMPLANTATION SITE. THE SURGEON DRILLED NEW BONE SOCKET EACH TIME THE ANCHORS PULLED OUT. THE CASE WAS COMPLETED SUCCESSFULLY USING A PUSHLOCK. THIS WAS DISCOVERED DURING A BANKART REPAIR PROCEDURE. THE CASE WAS DELAYED ABOUT TWENTY MINUTES. ADDITIONAL INFORMATION RECEIVED ON 10/26/2023: THE PROCEDURE TOOK PLACE ON 10/25/2023.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18184564 ↗
• MalfunctionOct 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 9/26/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AR-1938BC BIOCOMPOSITE SUTURETAK AND AN AR-3636 KNOTLESS FIBERTAK ANCHORS PULLED OUT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17996188 ↗
• MalfunctionJan 3, 2023Break

  ON 12/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1938BC BIOCOMPOSITE SUTURETAK ANCHOR BROKE. THIS WAS DISCOVERED DURING A GLENOHUMERAL INSTABILITY PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED USING ANOTHER AR-1938BC BIOCOMPOSITE SUTURETAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086307 ↗
• MalfunctionNov 7, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1938BC BIOCOMPOSITE SUTURETAK ANCHOR BROKE DURING INSERTION. A BONE TUNNEL WAS DRILLED WITH A 3.0 SUTURETAK DRILL AND ANOTHER SUTURETAK WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743497 ↗
• MalfunctionDec 21, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-1938BC KNOTLESS SUTURE TAK BROKE DURING AN SCR SHOULDER PROCEDURE. THE SUTURE BROKE AND PULLED FREE FROM THE ANCHOR DURING TENSIONING. THE IMPLANT STAYED IN THE PATIENT BUT THE BROKEN SUTURES WERE REMOVED. THE SURGEON DRILLED TWO ADDITIONAL HOLES AND IMPLANTED TWO MORE ANCHORS FROM A DIFFERENT LOT AND CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053596 ↗
• MalfunctionOct 26, 2021Loose or Intermittent Connection; Defective Device; Therapeutic or Diagnostic Output Failure

  ON 10/7/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) KNOTLESS SUTURETAK FAILED TO TENSION DOWN. THIS WAS DISCOVERED DURING A HIP LABRAL RECONSTRUCTION ON (B)(6) 2021 USING A COMBINATION OF SHOULDER FIBERTAKS AND SHOULDER KNOTLESS SUTURETAKS. SURGEON WAS ABLE TO SUCCESSFULLY IMPLANT 6 SUTURETAKS OUT OF A TOTAL OF 9. ALL THREE SUTURETAKS FAILED TO COMPLETE THE TENSIONING CYCLE LEAVING LOOP TOO LOOSE. SURGEON COMPLETED CASE BY REPLACING THE THREE FAILED DEVICES WITH THREE NEW ONES. ADDITIONAL INFORMATION RECEIVED 10/8/2021. THE SURGEON DRILLED OUT DEFECTIVE ANCHORS, WHICH WERE IN PIECES, AND RE-DRILLED IN THE SAME STOP THE 3 NEW SUTURETAK. AFTER SPEAKING TO SALES REP, HE IS NOT 100% SURE IF ALL FRAGMENTS OF THE 3 FAILED ANCHORS WERE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12697222 ↗
• MalfunctionMay 10, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SHUTTLE STITCH PULLED OUT WITH THE INSERTER DURING A LABRAL REPAIR USING KNOTLESS SUTURETAKS. ONLY ONE END OF THE SHUTTLE STITCH REMAINED IN THE JOINT SO IT WAS NOT POSSIBLE TO COMPLETE THE KNOTLESS MECHANISM. THE ANCHOR WAS LEFT IN PLACE AND THE REPAIR STITCH FROM A PUSHLOCK ANCHOR WAS USED TO COMPLETE THE CASE SUCCESSFULLY.

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

  MAUDE report 11798325 ↗
• MalfunctionApr 27, 2021Break

  IT WAS REPORTED DURING A LABRAL REPAIR PROCEDURE THE REPAIR SUTURE ON A QUANTITY TWO AR-1938BC ANCHORS SNAPPED AS THE SURGEON WAS SHUTTLING THE REPAIR STITCH THROUGH THE ANCHOR BODY. THERE WERE MULTIPLE OTHER AR-1938'S USED, BUT ONLY THE ONES FROM THIS LOT NUMBER BROKE IN THIS MANNER. SOCKETS WERE DRILLED USING THE AR-1938D IN THE GLENOID. ONCE THE ANCHORS BROKE, THE SURGEON DRILLED THEM OUT AND COLLECTED THE DEBRIS USING A SHAVER. NO PIECE FROM THE UNSUCCESSFUL ANCHORS WERE LEFT IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11730918 ↗
• MalfunctionApr 13, 2021Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING THE SHUTTLING PROCESS OF THE AR-1938BC SUTURES AS THE SURGEON STARTED TO TUG ON THE SHUTTLING STITCH, THE SUTURE TORE AND RIPPED OUT. THIS SAME EXACT ISSUE OCCURRED WITH A TOTAL OF FOUR AR-1938BC (LOT: 11515574). TWO OF THE ANCHOR BODIES WERE RETAINED IN THE JOINT AND TWO WERE REMOVED INTACT. THE CASE WAS COMPLETED BY OPENING A NEW BOX AND USING AN ADDITIONAL FOUR AR-1938BC. NO UNPLANNED INCISIONS WERE NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655751 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE PERFORMING A (B)(6) 2020 INFERIOR ANTERIOR AND POSTERIOR LABRAL REPAIR OF A LEFT SHOULDER, THE SURGEON DECIDED TO USE A KNOTLESS FIBERTAK (AR-3638) TO ACCESS THE 5 O'CLOCK POSITION (LOW ANTERIOR) OF THE GLENOID. A KNOTLESS FIBERTAK HAD ALREADY BEEN PLACED AT THE INFERIOR-MOST ASPECT OF THE GLENOID. THE DRILL GUIDE (AR-3638DC) WAS PLACED THROUGH THE ANTERIOR PORTAL ONTO THE LOW ANTERIOR GLENOID RIM. THE DRILL GUIDE WAS GENTLY TAPPED WITH A MALLET TO SEAT IT ON THE RIM. THE APPROPRIATE KNOTLESS FIBERTAK DRILL BIT WAS INSERTED INTO THE DRILL GUIDE AND DRILLED INTO THE GLENOID. THE SURGEON OBSERVED THAT THE BONE FELT "VERY HARD" AS THE DRILL WAS BEING ADVANCED. THE DRILLING WAS COMPLETED AND THE DRILL WAS REMOVED. THE ANCHOR WAS THEN INSERTED DOWN THE DRILL GUIDE AND MALLETED INTO THE SOCKET. WHEN THE KNOTLESS FIBERTAK INSERTER WAS GENTLY TUGGED ON TO SET THE ANCHOR, THE ANCHOR EXPLANTED FROM THE SOCKET IN ITS ENTIRETY. A KNOTLESS SUTURETAK (AR-1938BC) WAS USED ADJACENT TO THE KNOTLESS FIBERTAK POSITION, JUST SLIGHTLY SUPERIOR. NO CONCERNS WERE NOTED OR ADDRESSED AT THE TIME OF SURGERY. TWO WEEK POST OPERATIVE X-RAY IMAGES SHOWED A METALLIC OBJECT IN THE LOW

  Patient problems: Foreign Body In Patient

  MAUDE report 10785920 ↗
• InjuryApr 22, 2020Break

  IT WAS REPORTED THAT TWO SUTURETAK KNOTLESS SUTURE ANCHOR, AR-1938BC, WERE BEING USED IN AN ATFL REPAIR PROCEDURE. WHEN THE SUTURE ON BOTH ANCHORS WAS PASSED THROUGH THE LIGAMENT TISSUE AND TENSIONED, THE SUTURE BROKE. THE SURGEON CHANGED THE PROCEDURE TO DIRECT VISION AND COMPLETED THE PROCEDURE WITH PRODUCTS FROM ANOTHER MANUFACTURER. THE TWO ANCHORS WERE NOT REMOVED AND REMAINED IN THE PATIENT'S FIBULA. ON 04/07/2020: REPORTER CONFIRMED THAT "DIRECT VISION" IS AN OPEN PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9985564 ↗
• InjuryOct 11, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE (DATE OF SURGERY CURRENTLY UNKNOWN). THE PATIENT RE-TORE THEIR ROTATOR CUFF AND HAD A REVISION RCR ON (B)(6) 2019. DURING THE REVISION IT WAS DISCOVERED THAT THE PATIENT'S CUFF WAS IRREPARABLE AND THE SURGEON SWITCHED TO A SUPERIOR CAPSULE RECONSTRUCTION. DUE TO THE SOFT BONE QUALITY THE FOLLOWING ARTHREX PARTS BEING USED WOULD NOT STAY SEATED IN THE BONE: AR-1938BC // LOT: 10265961 // QTY.: 1. AR-1938BC // LOT: F189852 // QTY.: 1. THE REP STATED THE PROCEDURE WAS ARTHROSCOPIC. IT IS UNKNOWN IF ARTHREX PARTS WERE USED DURING THE ORIGINAL RCR; HOWEVER, NO ARTHREX PRODUCTS WERE REMOVED DURING THE REVISION ON (B)(6) 2019. THE REP STATED THERE WERE NO FURTHER ISSUES WITH ANY OTHER ARTHREX PRODUCTS DURING THE CASE. THE HUSBAND OF THE PATIENT CALLED THE SURGEON ON (B)(6) 2019, STATING THE LATERAL PORTAL WOUND WAS DRAINING FLUID AND THEY WERE WORRIED ABOUT INFECTION. THE PATIENT CAME IN FOR A FOLLOW-UP VISIT WITH THE SURGEON ON (B)(6) 2019 TO HAVE THE WOUND LOOKED AT. THE REP STATED THEY CANNOT CONFIRM IF CULTURES WERE TAKEN. AT THE MOMENT NO REVISION PROCEDURE IS SCHEDULED, BUT THE PATIENT HAS BEEN SCHEDULED TO CO

  Patient problems: No Code Available

  MAUDE report 9178797 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT THAT SHE HAD UNDERGONE HIP SURGERY (B)(6) 2018 DURING WHICH ARTHREX PRODUCTS WERE IMPLANTED. ALMOST IMMEDIATELY AFTER THE SURGERY THE PATIENT BEGAN HAVING A SEVERE BURNING SENSATION IN HER BODY WHICH HAS NOT GONE AWAY. AT TIME OF REPORT PATIENT DID NOT HAVE PART NUMBERS OR ANY ADDITIONAL INFORMATION WHICH HAS BEEN REQUESTED. DURING THE (B)(6) 2018 PROCEDURE AN (B)(4), KNOTLESS SUTURE ANCHOR BIO-COMPOSITE S-TAK, WAS IMPLANTED. PATIENTS SYMPTOMS RANGE OVER HER ENTIRE BODY HOWEVER THE SURGICAL SITE HURTS MORE AND EXPERIENCES THE SYMPTOMS MORE THAN THE OTHER PARTS OF HER BODY. SYMPTOMS INCLUDE: SWEATING CONTINUALLY, ESPECIALLY AT NIGHT, PAIN AT THE SURGICAL SITE, KNEES GETS SO BAD SOMETIMES SHE CANNOT MOVE HER KNEE - SOMETIMES HAVING PERIODS OF HOURS WHERE SHE CANNOT WALK UNTIL THE PAIN HAS PASSED, BURNING SENSATION THROUGHOUT HER ENTIRE BODY, FACE BECOMES RED TO THE POINT OF APPEARING AS IF SHE HAS AN ALLERGY OR RASH, HER FEET GET NUMB FROM HER KNEE TO WHERE SHE HAD SURGERY - LOSING FEELING AS IF THE NERVE HAS GONE NUMB AND SHE HAS LOST A LOT OF WEIGHT. PATIENT HAS NO KNOWN ALLERGIES. PATIENT HAS HAD BLOODWORK WHICH WAS NEGATIVE AND PATIENT HAS PROVIDED BL

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Numbness; Pain; Weight Changes

  MAUDE report 7942977 ↗
• InjurySep 11, 2018Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER ARTHROSCOPY LABRAL REPAIR THE IMPLANT WITHIN THE AR-1938BC SUTURE ANCHOR, BIOCOMPOSITE SUTURETAK SPLIT AND WAS STILL LODGED PARTIALLY IN THE INSTRUMENT. THE RN SATED THAT THE SUTURE ALSO BROKE. THE AR-1938BC BROKE AND SPLIT LENGTHWISE AFTER THE IMPLANT WAS SEATED. THE IMPLANT REMAINS PARTIALLY IN THE PATIENT, AND NO OTHER IMPLANTS WERE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 09/07/2018: THE FACILITY CONFIRMED THAT HALF OF THE IMPLANT WAS LEFT IN THE PATIENT. THE FACILITY CONFIRMED THAT THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 7863804 ↗
• InjuryJul 17, 2018Break

  IT WAS REPORTED THAT THE AR-1938BC, BIOCOMPOSITE SUTURETAK KNOTLESS ANCHOR BROKE UPON INSERTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION OBTAINED: THE PROCEDURE TAKING PLACE WAS A LABRUM REPAIR. THE SURGICAL COORDINATOR STATED THAT THE ONLY INFORMATION MADE AVAILABLE REGARDING THE COMPLAINT WAS THAT THE DEVICE BROKE IN AND OUT UPON INSERTION. THE CASE WAS COMPLETED WITH A REPLACEMENT AR-1938BC OF THE SAME LOT NUMBER (LOT: 10071743). THE FACILITY CONFIRMED THAT THE DEVICE WILL NOT BE RETURNING FOR EVALUATION DUE TO THE UNKNOWN DISPOSITION OF THE DEVICE. THE FACILITY REPORTER STATES THEY HAVE NO CONFIRMATION ON THE STATUS OF WHETHER THERE IS A RETAINED DEVICE PORTION LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7693316 ↗
• InjuryNov 30, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SLAP PROCEDURE, AFTER THE SURGEON INSERTED THE 3.0 BIO-COMPOSITE KNOTLESS SUTURE TAK INTO THE GLENOID, HE BEGAN TO PULL TRACTION WITH THE SUTURE AND THE TOP PORTION OF THE ANCHOR PULLED OUT. THE DISTAL PORTION OF THE ANCHOR REMAINED IN THE PATIENT'S GLENOID. NO FURTHER DETAILS HAVE BEEN GIVEN BUT ADDITIONAL INFORMATION HAS BEEN REQUESTED. PATIENT IS A MALE, (B)(6). FOLLOW-UP INVESTIGATION: A LITTLE MORE THAN 3/4 OF THE SUTURE TAK WAS LEFT IN THE GLENOID. ANOTHER SUTURE TAK WAS USED AND PLACED NEXT TO THE FIRST ONE. THE SAME DRILL BIT WAS USED FOR BOTH SUTURE TAKS. NO ADDITIONAL UNPLANNED INCISION WAS MADE, THE SURGEON USED THE SAME PORTAL. THE TOP PORTION OF THE AR-1938BC SUTURE TAK IS BEING RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7070098 ↗
• InjurySep 14, 2017Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE WHILE PASSING THE STITCH BACK THROUGH THE BIO-COMPOSITE SUTURE TAK KNOTLESS SUTURE ANCHOR, THE PASSING STITCH WOULD BREAK BEFORE THE LOOP WOULD EVEN REACH THE ANCHOR. THIS HAPPENED 2 MORE TIMES WITH THE 2 MORE DEVICES FROM THE SAME LOT NUMBER. THE SURGEON WAS FORCED TO REVERT TO A KNOTTED REPAIR. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6865017 ↗