Arthrex® AR-2324BCMRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867026865), received between Oct 3, 2016 and Jan 10, 2025 — classified as 15 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (16 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 24, 2017Terminated

   Some eyelets broke from SwiveLock Anchor on insertion.

   Z-2043-2017 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT THREE AR-2324BCM BIO-COMPOSITE SWIVELOCK SP SUTURES BROKE IN THE MIDDLE, WHERE IT MEETS THE EYELET, DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/20/2024: THE DISTRIBUTOR REPORTED THAT ONLY ONE AR-2324BCM BIO-COMPOSITE SWIVELOCK SP HAD ISSUES DURING THIS RCR PROCEDURE ON (B)(6) 2024. THE SUTURES BROKE AFTER IMPLANTATION, AND THE ANCHORS REMAINED IN THE PATIENT. THE CASE WAS COMPLETED USING A NEW AR-2324BCM BIO-COMPOSITE SWIVELOCK SP. THE CASE WAS DELAYED TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 21125917 ↗
• MalfunctionJan 10, 2025Break; Break

  ON 12/13/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT THREE AR-2324BCM BIO-COMPOSITE SWIVELOCK SP SUTURES BROKE IN THE MIDDLE, WHERE IT MEETS THE EYELET, DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/20/2024: THE DISTRIBUTOR REPORTED THAT ONLY ONE AR-2324BCM BIO-COMPOSITE SWIVELOCK SP HAD ISSUES DURING THIS RCR PROCEDURE ON (B)(6) 2024. THE SUTURES BROKE AFTER IMPLANTATION, AND THE ANCHORS REMAINED IN THE PATIENT. THE CASE WAS COMPLETED USING A NEW AR-2324BCM BIO-COMPOSITE SWIVELOCK SP. THE CASE WAS DELAYED TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 21125659 ↗
• MalfunctionJan 10, 2025Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT THREE AR-2324BCM BIO-COMPOSITE SWIVELOCK SP SUTURES BROKE IN THE MIDDLE, WHERE IT MEETS THE EYELET, DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/20/2024: THE DISTRIBUTOR REPORTED THAT ONLY ONE AR-2324BCM BIO-COMPOSITE SWIVELOCK SP HAD ISSUES DURING THIS RCR PROCEDURE ON (B)(6) 2024. THE SUTURES BROKE AFTER IMPLANTATION, AND THE ANCHORS REMAINED IN THE PATIENT. THE CASE WAS COMPLETED USING A NEW AR-2324BCM BIO-COMPOSITE SWIVELOCK SP. THE CASE WAS DELAYED TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 21125608 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR BROKE INSIDE PATIENT SHOULDER. FRAGMENTS OF THE DEVICE REMAINED IN THE PATIENT' S SHOULDER, AS THESE COULD NOT BE RETRIEVED. 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 20612316 ↗
• 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 20560443 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT WAS UNDERGOING A SHOULDER ARTHROSCOPY AND BICEPS TENODESIS. THE DEVICE WAS BEING USED FOR TENODESIS. AFTER SCREWING IN THE ANCHOR AND REMOVING THE INSERTION DEVICE IT WAS NOTED THAT SOME OF THE ANCHOR HAD BROKEN WITHIN THE PATIENT. THE BROKEN PIECES WERE REMOVED. FIXATION WAS CHECKED AND FOUND TO STILL BE FIRM. THEREFORE NO FURTHER ACTION WAS REQUIRED AT THAT TIME.

  Patient problems: Insufficient Information

  MAUDE report 19817141 ↗
• InjuryJun 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INITIAL ROTATOR CUFF SUTURE SURGERY ON (B)(6) 2019 THE PATIENT STARTED TO EXPERIENCED MAJOR PROBLEMS (REDNESS, ITCHING AND PARTIALLY OPEN AREAS) AT THE OPERATED SITE. NO FURTHER INFORMATION RECEIVED. UPDATE DW 29-MAY-2024: THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2019 IN (B)(6) AND AN MEDICAL EXAMINATION WILL BE PERFORMED ON (B)(6) 2024 IN (B)(6).

  Patient problems: Itching Sensation

  MAUDE report 19587945 ↗
• MalfunctionApr 23, 2024Missing Information; Missing Information

  IT WAS REPORTED THE IMPLANTS WERE RECEIVED WITH NO LABELS ON THE PACKAGING. THE OUTSIDE BOX WAS LABELED BUT THERE WERE NO STICKERS ON THE INDIVIDUAL ITEMS. THIS WAS DISCOVERED DURING A CASE AND TWO WERE USED. NO CASE OR PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163446 ↗
• InjuryMar 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A PATIENT VIA PHONE THAT AFTER UNDERGOING A PROCEDURE WHERE AN AR-2324BCM SUTURE ANCHOR WAS IMPLANTED HAD BEEN EXPERIENCING PAIN SINCE. THE PATIENT HAS A MASS ON THE RIGHT SIDE OF HER BACK, AND IT'S SIMILAR TO WHAT SHE EXPERIENCED IN HER FOOT WHEN PEEK WAS IMPLANTED. THE PROCEDURE TOOK PLACE ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Pain

  MAUDE report 18868487 ↗
• MalfunctionMay 24, 2021Break; Entrapment of Device

  IT WAS REPORTED AFTER THE AR-2324BCM ANCHOR WAS IMPLANTED, THE SURGEON PASSED THE SUTURE THROUGH THE TENDON AND WAS TYING A KNOT AND THE SUTURE BROKE WITH VERY LITTLE TENSION. THE ANCHOR WAS REMOVED, BUT THE METAL TIP OF THE ANCHOR IS STILL IN THE PATIENT. NO INJURIES OCCURRED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 6.5 CORKSCREW.

  Patient problems: Foreign Body In Patient

  MAUDE report 11872402 ↗
• InjurySep 16, 2019Break; Loose or Intermittent Connection

  IT WAS REPORTED VIA THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT HAD UNDERGONE SURGERY ON (B)(6) 2018 FOR ROTATOR CUFF AND TENDON REPAIRS. ACCORDING TO THE IMPLANT LOG PROVIDED THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED: AR-2324BCCT, BIOCOMPOSITE SWIVELOCK C (QTY 1, LOT # F171853) AR-2324BCM, BIOCOMPOSITE SWIVELOCK SP (QTY 2, LOT # F158844). ACCORDING TO THE OPERATIVE REPORT, THE SURGEON IMPLANTED TWO (2) ARTHREX SWIVELOCK® ANCHORS AT THE JUNCTION OF THE ARTICULAR CARTILAGE AND THE GREATER TUBEROSITY. THE ARTHREX FIBERTAPE WAS THEN PASSED THROUGH THE TORN ROTATOR CUFF, CRISSCROSSED, AND SECURED TO BONE WITH TWO (2) LATERAL ARTHREX SUTURE ANCHORS. THIS CREATED CLOSURE OF THE TENDON BACK DOWN TO BONE. ALTHOUGH THE OPERATIVE REPORT NOTED THAT A TOTAL OF FOUR (4) ARTHREX SUTURE ANCHORS WERE IMPLANTED, THE IMPLANT LOG SHOWS ONLY THREE (3) ANCHORS WERE USED. APPROXIMATELY TWO WEEK POST-OP THE PATIENT HAD AN X-RAY TAKEN AND AT THE TIME OF THE X-RAY THE PATIENT WAS REPORTING PAIN IN THE LEFT SHOULDER. THE X-RAY FINDINGS INDICATED ONE OF THE SURGICAL ANCHORS WAS NOTED TO PROJECT WITHIN THE SOFT TISSUES ON THE AP VIEW. THE PATIENT'S (B)(6) 2018 PHYSICAL THERAPY RECORDS NOTE THAT THE

  Patient problems: Pain

  MAUDE report 9069854 ↗
• InjuryNov 2, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE AR-2324BCM, SUTURE ANCHOR, BIO-COMPOSITE SWIVELOCK BROKE OFF AS THE SURGEON WAS TWISTING THE HANDLE TO INSERT THE IMPLANT INTO THE BONE DURING AN ARTHROSCOPY ROTATOR CUFF REPAIR PROCEDURE. THE RN STATED THAT PART OF THE IMPLANT REMAINS SECURELY IN THE PATIENT. THE FACILITY CONFIRMED THAT THE DEVICE WILL BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 10/15/2018: THE FACILITY CONFIRMED THAT THERE WAS NOT A ARTHREX SALES REPRESENTATIVE PRESENT DURING THE PROCEDURE. THE CASE WAS COMPLETED BY USING A 4.5 SWIVELOCK. THE RN STATED THAT A TAP WAS USED, AND THE BONE QUALITY WAS MEDIUM.

  Patient problems: No Code Available

  MAUDE report 8032198 ↗
• InjuryJun 21, 2018Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A RUPTURE OF THE SUPRASPINATUS TENDON SURGERY THE SWIVELOCK BROKE OFF WHEN TURNING IN. ADDITIONAL INFORMATION OBTAINED 12 JUNE 2018: THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE OF THE SAME PART NUMBER. THE NEW DEVICE WAS PLACED ON A DIFFERENT SPOT - IT IS NOT COVERING THE BROKEN ANCHOR. THE ANCHOR BROKE AND 2/3 OF THE ANCHOR WILL REMAIN INSIDE THE BONE WELL FIXED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7625090 ↗
• InjuryJun 21, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A RUPTURE OF THE SUPRASPINATUS TENDON SURGERY THE SWIVELOCK BROKE OFF WHEN TURNING IN. ADDITIONAL INFORMATION OBTAINED 12 JUNE 2018: THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE OF THE SAME PART NUMBER. THE NEW DEVICE WAS PLACED ON A DIFFERENT SPOT - IT IS NOT COVERING THE BROKEN ANCHOR. THE ANCHOR BROKE AND 2/3 OF THE ANCHOR WILL REMAIN INSIDE THE BONE WELL FIXED.

  Patient problems: No Information

  MAUDE report 7624842 ↗
• InjuryJun 19, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A RUPTURE OF THE SUPRASPINATUS TENDON THE SWIVELOCK BROKE OFF WHEN TURNING IN. ***UPDATE SMER 12 JUNE 2018: THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE OF THE SAME PART NUMBER. THE NEW DEVICE WAS PLACED ON A DIFFERENT SPOT - IT IS NOT COVERING THE BROKEN ANCHOR. THE ANCHOR BROKE AND 2/3 OF THE ANCHOR WILL REMAIN INSIDE THE BONE WELL FIXED.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 7614027 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information

  IT WAS REPORTED BY PATIENT THAT SHE HAD UNDERGONE A PROCEDURE ON (B)(6) 2017 FOR RIGHT ROTATOR CUFF REPAIR, BICEP TENODESIS AND AC JOINT DECOMPRESSION. DURING THE PROCEDURE PATIENT RECEIVED SWIVELOCK ANCHORS AND BIO-TENODESIS SCREW IMPLANTS. SINCE SURGERY THE PATIENT HAS EXPERIENCED UNUSUAL SWELLING, WITH HER BICEPS BEING APPROXIMATELY DOUBLE ITS NORMAL SIZE. PATIENT IS ALSO EXPERIENCING THE FOLLOWING SINCE SURGERY: PAIN IN HER SHOULDER THAT IS DIFFERENT FROM THE TYPE OF PAIN EXPERIENCED PRIOR TO THE SURGERY AND AN UPPER BODY RASH THAT APPEARS TO RUN ALONG HER LYMPH NODE SYSTEM. PATIENT HAS HAD LYMPHATIC DRAINAGE MASSAGES TO TRY AND ALLEVIATE HER SYMPTOMS WITH NO SUCCESS. PATIENT MENTIONED THAT SHE SUFFERS FROM CELIAC, IS ALLERGIC TO MANY FOODS AND IS ALSO ALLERGIC TO COSTUME JEWELRY (NON-GOLD). PATIENT ALSO STATED THAT SHE HAS HAD PAST REACTION TO DENTAL IMPLANTS WHICH CAUSED EXTENSIVE WORK ONCE THE DEVICE WAS DETERMINED TO BE CAUSING THE PROBLEMS. PATIENT HAS REQUESTED THE MATERIAL COMPOSITION OF HER IMPLANTS TO HELP DETERMINE IF THERE IS A COMPONENT THAT MAY BE CAUSING HER ISSUES. ADDITIONAL INFORMATION OBTAINED 11/21/2017: DURING THE (B)(6) 2017 SURGERY THE PATIENT RECEIVED THE

  Patient problems: Pain; Swelling

  MAUDE report 7108029 ↗
• InjuryJun 23, 2017Break; Detachment Of Device Component; Nonstandard Device

  DURING MONTHLY MAUDE REVIEW THE FOLLOWING INCIDENT WAS DISCOVERED REPORTED BY THE FACILITY (REPORT NUMBER MW5069183): DURING A RIGHT ROTATOR CUFF REPAIR, THE TIP OF AN ARTHREX SUTURE ANCHOR, BIOCOMPOSITE SWIVEL LOCK SP SELF PUNCHING 4.75 X 24.5 MM BROKE OFF. UNSURE IF RETRIEVED COMPLETE INTACT TIP. THE MAUDE REPORT DID NOT CONTAIN ANY FACILITY INFORMATION OR REPORTER CONTACT INFORMATION. FOLLOW UP NOT POSSIBLE.

  Patient problems: No Information

  MAUDE report 6662789 ↗
• InjuryApr 13, 2017Break; Material Fragmentation; Nonstandard Device

  IT WAS REPORTED THAT DURING A RIGHT ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON WAS ATTEMPTING TO INSERT A 4.75MMX24.5MM BIO-COMPOSITE SWIVELOCK WHEN THE TIP BROKE OFF INTO THE PATIENT'S JOINT. THE SURGEON RETRIEVED SOME OF THE FRAGMENTS WITH A GRASPER HOWEVER, HE WAS NOT CONFIDENT THAT ALL PIECES WERE RETRIEVED. NO ATTEMPTS WERE MADE TO CONFIRM WHETHER OR NOT THERE WERE STILL DEVICE FRAGMENTS LEFT IN THE PATIENT. A NEW 4.75MMX24.5MM BIO-COMPOSITE SWIVELOCK (LOT UNKNOWN) WAS OPENED AND USED TO COMPLETE THE CASE WITHOUT FURTHER INCIDENT. SLIGHT DELAY IN CASE. PATIENT IS A (B)(6) MALE. ADDITIONAL INFORMATION OBTAINED 3/28/17: THE TITANIUM PORTION OF THE DEVICE HAS A CONE THAT IS CONNECTED TO THE TITANIUM PIN WITH TWO FLAT LEGS ATTACHED FROM THE BACK SIDE OF THE CONE TO THE TITANIUM PIN. THE CONE BROKE FREE FROM THE PIN DURING IMPLANTATION. WHEN THE CONE WAS RETRIEVED ONLY ONE OF THE CONNECTING LEGS WAS ATTACHED TO THE CONE. THE OTHER WAS NOT ATTACHED TO THE CONE OR THE TITANIUM PIN. IT IS UNKNOWN IF THE MISSING TITANIUM LEG IS IN THE PATIENT AS IT WAS NOT FOUND OR RETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6490498 ↗
• InjuryMar 10, 2017Break; Detachment Of Device Component; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A 4.75MM X 24.5MM SELF-PUNCHING BIOCOMPOSITE SWIVELOCK (AR-2324BCM) WAS BEING USED IN A ROTATOR CUFF REPAIR PROCEDURE. THE SURGEON PLACED THE FIBERTAPE ONTO THE SWIVELOCK, AND PLACED IT INTO THE CANNULA. A HOLE WAS NOT PRE PUNCHED FOR THIS SWIVELOCK. ONCE THE IMPLANT TOUCHED BONE, THE SURGEON WENT TO MALLET IT IN. WHEN THAT HAPPENED, THE EYELET BROKE, AND THE TIP IS NO LONGER ATTACHED TO THE SUTURE. THE FIBERTAPE PORTION OF THE IMPLANT WAS REMOVED, AND THE REMAINING PART OF THE TIP WITH THE STAY SUTURE WAS STILL FIRMLY ATTACHED TO THE INSERTER AND CAME OUT OF THE PATIENT. THE EYELET WAS STILL LEFT INSIDE THE PATIENT. THE SURGEON ATTEMPTED TO REMOVE THE EYELET WITH USING A C-ARM, AND TRIANGULATING THE CAMERA AND PROBES IN ORDER TO LOCATE AND REMOVE THE EYELET. AN RF ABLATOR WAS ALSO USED TO ABLADE TISSUE AWAY TO HELP REMOVE THE EYELET. THE SURGEON THEN DECIDED TO SWITCH TO AN OPEN-MINI PROCEDURE TO REMOVE THE EYELET. IT WAS FINALLY FOUND AND RETRIEVED USING A GRASPER. THIS ADDED AN HOUR AND TWENTY MINUTES TO THE PROCEDURE. THE SURGEON USED TWO 4.75MM X 24.5MM SELF-PUNCHING BIOCOMPOSITE SWIVELOCKS OF THE SAME LOT NUMBER, AND PRE-PUNCHED HOLES TO INSERT THESE, AND

  Patient problems: Foreign Body In Patient

  MAUDE report 6394903 ↗
• InjuryDec 12, 2016Bent; Break; Detachment Of Device Component

  IT WAS REPORTED THAT FOUR 4.75MM X 24.5MM BIOCOMPOSITE SWIVELOCKS WERE BEING USED IN A ROTATOR CUFF REPAIR PROCEDURE. DURING THE PROCEDURE, THE BONE WAS PREPARED USING AN SP ANCHOR. WHEN INSERTING THE FIRST SWIVELOCK, AR-2324BCM LOT 10017622 (CC100895 LINE 176380), IT BENT, AND WAS NOT ABLE TO BE INSERTED SUCCESSFULLY. ANOTHER SWIVELOCK, AR-2324BCM LOT 10038551 (CC100895 LINE 176385) WAS ATTEMPTED AND AS THE ANCHOR WAS BEING INSERTED INTO THE BONE, IT BROKE. THE SAME EVENT HAPPENED WITH TWO OTHER SWIVELOCKS, FROM LOT 10038551 (CC100895 LINE 176385). THE TIP OF THESE THREE ANCHORS STILL REMAIN IN THE PATIENT, LODGED AT THE BOTTOM OF THE BONE TUNNEL. ALL OTHER BROKEN PIECES WERE RETRIEVED. OTHER AR-2324BCM, 4.75MM X 24.5MM BIOCOMPOSITE SWIVELOCKS, IMPLANTED IN A DIFFERENT AREA OF THE HUMERAL HEAD WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY REPORTED. BONE QUALITY REPORTED TO BE AVERAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6166158 ↗
• InjuryOct 27, 2016Break; Detachment Of Device Component; Crack; Entrapment of Device

  IT WAS REPORTED THAT THE 4.75MM X 24.5MM BIOCOMPOSITE SWIVELOCK, AR-2324BCM, WAS BEING USED IN A PROCEDURE. THE BONE WAS PREPARED USING A SELF PUNCHING SWIVELOCK. WHEN THE SURGEON WAS IMPLANTING THE ANCHOR, THE ANCHOR CRACKED. THE SURGEON MALLETED THE ANCHOR TO THE BONE. HE THEN HELD THE THUMB PAD AND BEGAN TWISTING THE KNOB. ONCE THE ANCHOR WAS FULLY SEATED, THE SURGEON PULLED THE SWIVELOCK DRIVER OUT, AND THE ANCHOR CAME OUT WITH IT. THE DISTAL TIP OF THE ANCHOR BROKE OFF. A SMALL PIECE OF THE ANCHOR WAS LEFT IN THE PRE-PUNCHED SOCKET. PATIENT: MALE.

  Patient problems: No Information

  MAUDE report 6060458 ↗
• InjuryOct 3, 2016Insufficient Device Problem Information

  IT WAS REPORTED BY PATIENT THAT SHE UNDERWENT A RIGHT ROTATOR CUFF REPAIR ON (B)(6) 2011. PATIENT WAS INQUIRING THE MATERIAL COMPOSITION OF HER IMPLANTS. SPECIFIC IMPLANT PART NUMBERS WERE NOT KNOWN. PATIENT WAS DIRECTED TO CONTACT THE PROCEDURE FACILITY TO REQUEST THE IMPLANT LOG TO OBTAIN SPECIFIC PART NUMBERS. ADDITIONAL INFORMATION OBTAINED (B)(6) 2016: PATIENT PROVIDED PART NUMBERS OF THE IMPLANTS FOR WHICH SHE NEEDS MATERIAL COMPOSITION: (B)(4) ((B)(4)) AND (B)(4) ((B)(4)). MATERIAL COMPOSITION HAS BEEN PROVIDED TO THE PATIENT. ADDITIONAL INFORMATION OBTAINED (B)(6) 2016: PATIENT STATES SHE HAS BEEN HAVING A REACTION IN THE HEALING PROCESS SUCH THAT THE INCISION AREA HAS NEVER HEALED AND HAS STAYED RED WITH INFLAMMATION AND AT TIMES ITCHY. IN (B)(6) 2013 PATIENT WENT TO ER FOR DIFFICULTY BREATHING. SINCE THAT TIME PATIENT HAS DEALT WITH A MULTITUDE OF ISSUES AND HAS BEEN SEEN BY MANY SPECIALIST AT SEVERAL FACILITIES. PATIENT STATES RETENTION OF TOO MUCH CARBON DIOXIDE, FAST PACED BREATHING PATTERN, BODY IN STATE OF DEHYDRATION DESPITE ADEQUATE WATER INTAKE AND USING SALT, ELECTROLYTES AND HYALURONIC ACID, FATIGUE AND INCREASED ISSUE BREATHING DUE TO GASPING AND GLOBUS WITH PH

  Patient problems: Dehydration; Dyspnea; Erythema; Fatigue; Impaired Healing; Inflammation; Itching Sensation; Reaction

  MAUDE report 5995147 ↗