Arthrex® AR-8988-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888867377875), received between Jan 16, 2023 and Feb 19, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Detachment of Device or Device Component

  ON 03-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8988-CP FIBERLOCK SUSPENSION IMPLANT KIT EXPERIENCED AN ISSUE DURING USE IN A CM JOINT REPAIR PROCEDURE PERFORMED ON (B)(6) 2026. DURING INSERTION OF THE ANCHOR INTO THE PREPARED BONE HOLE, THE SUTURE TAPE DETACHED FROM THE ANCHOR, CAUSING THE ANCHOR TO FALL INTO THE PATIENT¿S THUMB. THE SURGEON WAS UNABLE TO LOCATE THE ANCHOR, AND IT IS POSSIBLE THE ANCHOR REMAINS WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW AR-8988-CP FIBERLOCK SUSPENSION IMPLANT KIT. NO SIGNIFICANT SURGICAL DELAY OR ADDITIONAL ANESTHESIA WAS REPORTED. NO ADDITIONAL SURGERY TO RETRIEVE THE ANCHOR IS CURRENTLY PLANNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24392597 ↗
• MalfunctionDec 3, 2025Material Frayed; Material Frayed

  ON 11/3/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE FIBERTAK ANCHOR FROM AN AR-8988-CP FIBERLOCK SUSPENSION IMPLANT KIT APPEARED DEFECTIVE, IT WOULDN¿T BUNCH UP AND LOOKED DAMAGED STRAIGHT OUT OF THE PACKAGE. THIS ISSUE WAS DISCOVERED DURING A CMC ARTHROPLASTY PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED USING ANOTHER AR-8988-CP FIBERLOCK SUSPENSION IMPLANT KIT. ADDITIONAL INFORMATION WAS RECEIVED ON 11/12/2025: THE WHITE SHEATH OF THE FIBERTAK ANCHOR APPEARED DAMAGED. IT WAS HEAVILY FRAYED AND WOULD NOT BALL UP PROPERLY WHEN THE SURGEON ATTEMPTED TO DEPLOY IT. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO PHOTOS WERE TAKEN OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23707473 ↗
• InjuryAug 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 07/25/2025, IT WAS REPORTED BY THE PATIENT VIA PHONE THAT THEY HAD UNDERGONE A LEFT-HAND TIGHTROPE CMC JOINT ARTHROPLASTY SUSPENSION PROCEDURE ON (B)(6) 2025, DURING WHICH AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM WAS IMPLANTED. AT APPROXIMATELY SIX WEEKS POST-SURGERY, THE PATIENT BEGAN EXPERIENCING SYMPTOMS CONSISTENT WITH COMPLEX REGIONAL PAIN SYNDROME (CRPS) IN THE LEFT HAND NEAR THE SITE OF IMPLANTATION. THE PATIENT EXPRESSED CONCERN THAT THEIR BODY MAY BE REJECTING THE IMPLANTED MATERIAL, CITING A HISTORY OF HYPERSENSITIVITY TO PRODUCTS AND A KNOWN ALLERGY TO METALS. BOTH THE PATIENT AND SURGEON ARE AWARE THAT THE AR-8988-CP PRODUCT DOES NOT CONTAIN METALLIC COMPONENTS. CURRENTLY, THE COMPLICATION IS BEING MANAGED WITH TWO STEROID INJECTIONS ADMINISTERED TO THE AFFECTED LEFT HAND AND ONGOING OCCUPATIONAL THERAPY. THE SURGEON CONFIRMED VIA X-RAY THAT THE THUMB HAS HEALED PROPERLY AND APPEARS NORMAL. AT THIS TIME, THE NEED FOR FURTHER SURGICAL INTERVENTION REMAINS UNDETERMINED, AND THE PATIENT'S DERMATOLOGIST REQUESTED TO CONDUCT A SCRATCH TEST SPECIFIC TO THE ARTHREX PRODUCT. THE PATIENT ALSO INQUIRED WHETHER ARTHREX COULD PROVIDE A SMALL PRODUCT SAMPLE FOR THE ALLERGY TESTI

  Patient problems: Hypersensitivity/Allergic reaction; Implant Pain

  MAUDE report 22773868 ↗
• InjuryJul 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 08/05/2025: THE PATIENT IS APPROXIMATELY FOUR MONTHS POST-OPERATIVE AND CONTINUES TO EXPERIENCE PERSISTENT PAIN AT THE BASE OF THE THUMB. THE THUMB FREQUENTLY CREAKS AND CRACKS WITH MOVEMENT, OFTEN CAUSING NIGHTTIME PAIN THAT DISRUPTS SLEEP. THE PATIENT HAS ALSO NOTED OCCASIONAL SKIN DISCOLORATION, APPEARING BLACK AND BLUE. PHYSICAL THERAPY HAS PROVEN INEFFECTIVE AND IRRITATES THE WRIST. DESPITE THE SURGEON¿S ASSESSMENT THAT EVERYTHING APPEARS NORMAL, THE PATIENT REPORTS THAT SYMPTOMS ARE NOW WORSE THAN PRIOR TO SURGERY.

  Patient problems: Complex regional pain syndrome; Limb Pain; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Skin Discoloration; Sleep Dysfunction

  MAUDE report 22665989 ↗
• MalfunctionJul 21, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8988-CP FIBERLOCK SUSPENSION IMPLANT KIT HAD AN ISSUE DURING USE. WHILE ANCHORING THE INITIAL 3.5 SL COMPONENT, THE IMPLANT FAILED. A SECOND 3.5 SL WAS OPENED AS A REPLACEMENT, BUT DURING TENSIONING INTO THE BONE, BOTH THE FIBERLOCK IMPLANT AND THE REPLACEMENT 3.5 SL FAILED. AS A RESULT, THEY DISCONTINUED USING THE FIBERLOCK SYSTEM AND COMPLETED THE PROCEDURE USING AN AR-8919DS IMPLANT SYSTEM, CMC MINI TIGHTROPE INSTEAD. THIS WAS DISCOVERED DURING A CMC PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 07/01/2025. THERE WAS NEVER A SECOND FIBERLOCK IMPLANT KIT OPENED. ONLY A SECOND 3.5 SWIVELOCK AFTER THE FIRST 3.5 SWIVELOCK FAILED IN THE THUMB. THEY USED A CMC TIGHTROPE TO FINISH THE REPAIR, BECAUSE THE FIBERLOCK IMPLANT PULLED THROUGH THE FIRST MET. THEY BELIEVE THE PATIENT'S BONE WASN'T VERY STRONG, BUT THE SECOND FAILED BECAUSE THE EYELET BROKE AFTER TRYING TO RESET. IT WAS REPORTED THAT ALL THE INSTRUMENTS USED FOR THIS WERE PROVIDED IN THE KIT AND USED CORRECTLY. THE PATIENT DID NOT EXPERIENCE ANY HARM, NOR WAS THERE NEGATIVE IMPACT ON THE PATIENT. ADDITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553816 ↗
• MalfunctionJul 21, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8988-CP FIBERLOCK SUSPENSION IMPLANT KIT HAD AN ISSUE DURING USE. WHILE ANCHORING THE INITIAL 3.5 SL COMPONENT, THE IMPLANT FAILED. A SECOND 3.5 SL WAS OPENED AS A REPLACEMENT, BUT DURING TENSIONING INTO THE BONE, BOTH THE FIBERLOCK IMPLANT AND THE REPLACEMENT 3.5 SL FAILED. AS A RESULT, THEY DISCONTINUED USING THE FIBERLOCK SYSTEM AND COMPLETED THE PROCEDURE USING AN AR-8919DS IMPLANT SYSTEM, CMC MINI TIGHTROPE INSTEAD. THIS WAS DISCOVERED DURING A CMC PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 07/01/2025. THERE WAS NEVER A SECOND FIBERLOCK IMPLANT KIT OPENED. ONLY A SECOND 3.5 SWIVELOCK AFTER THE FIRST 3.5 SWIVELOCK FAILED IN THE THUMB. THEY USED A CMC TIGHTROPE TO FINISH THE REPAIR, BECAUSE THE FIBERLOCK IMPLANT PULLED THROUGH THE FIRST MET. THEY BELIEVE THE PATIENT'S BONE WASN'T VERY STRONG, BUT THE SECOND FAILED BECAUSE THE EYELET BROKE AFTER TRYING TO RESET. IT WAS REPORTED THAT ALL THE INSTRUMENTS USED FOR THIS WERE PROVIDED IN THE KIT AND USED CORRECTLY. THE PATIENT DID NOT EXPERIENCE ANY HARM, NOR WAS THERE NEGATIVE IMPACT ON THE PATIENT. ADDITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553814 ↗
• MalfunctionMay 1, 2025Break; Positioning Failure; Break; Positioning Failure

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/07/2025: A CMC REPAIR USING FIBERLOCK WAS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A FIBERTAK ANCHOR FAILED TO DEPLOY INSIDE THE PATIENT. THE ANCHOR WAS REMOVED, AND NOTHING BROKE INSIDE THE PATIENT. TO COMPLETE THE CASE, ANOTHER AR-8988-CP FIBERLOCK SUSPENSION IMPLANT KIT WAS USED. THE PROCEDURE HAD NO DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. A DRILL FROM THE KIT WAS USED TO PREPARE THE BONE SOCKET, AND THE PATIENT'S BONE QUALITY WAS ASSESSED AS AVERAGE. THE DEVICE CANNOT BE RETURNED FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942475 ↗
• MalfunctionApr 3, 2025Positioning Failure; Positioning Failure

  ON 3/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FIBERTAK FROM AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM WOULD NOT DEPLOY ACROSS THE FAR CORTEX. AFTER RELOADING THE ANCHOR AND VERIFYING WITH FLUOROSCOPY THAT IT WAS ACROSS THE FAR CORTEX, THE ANCHOR WOULD NOT SET. THE CASE WAS COMPLETED BY DRILLING ANOTHER HOLE AND USING A NEW AR-8988-CP FIBERLOCK SUSPENSION SYSTEM. THIS WAS DISCOVERED DURING A CMC SUSPENSIONPLASTY PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 3/28/2025.

  Patient problems: Insufficient Information

  MAUDE report 21762140 ↗
• MalfunctionApr 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 3/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SUTURES FROM AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM WOULD NOT SLIDE UPON INSERTING THE ANCHOR. THE SURGEON HAD TO PULL THE ANCHOR OUT AND A NEW IMPLANT WAS USED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 3/27/2025.

  Patient problems: Insufficient Information

  MAUDE report 21752408 ↗
• MalfunctionFeb 4, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 1/7/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FIBERTAK DEVICES FROM TWO AR-8988-CP FIBERLOCK SUSPENSION SYSTEM BENT. THE CASE WAS COMPLETED USING A THIRD AR-8988-CP FIBERLOCK SUSPENSION SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 1/16/2025: THIS WAS DISCOVERED DURING A CMC SUSPENSION PLASTY WITH TRAPEZIECTOMY PROCEDURE. BOTH FIBERTAKS FROM THE KIT BENT DURING INSERTION. NOTHING BROKE IN THE PATIENT; THE ANCHORS WERE REMOVED. THE CASE WAS COMPLETED USING THE REST OF THE FAULTY KITS AND AN ADDITIONAL AR-8988-CP FIBERLOCK SUSPENSION SYSTEM. THE CASE WAS DELAYED ONLY A FEW MINUTES, AND ANESTHESIA WAS ADMINISTERED FOR THE ADDED TIME.

  Patient problems: Insufficient Information

  MAUDE report 21304041 ↗
• MalfunctionFeb 4, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 1/7/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FIBERTAK DEVICES FROM TWO AR-8988-CP FIBERLOCK SUSPENSION SYSTEM BENT. THE CASE WAS COMPLETED USING A THIRD AR-8988-CP FIBERLOCK SUSPENSION SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 1/16/2025: THIS WAS DISCOVERED DURING A CMC SUSPENSION PLASTY WITH TRAPEZIECTOMY PROCEDURE. BOTH FIBERTAKS FROM THE KIT BENT DURING INSERTION. NOTHING BROKE IN THE PATIENT; THE ANCHORS WERE REMOVED. THE CASE WAS COMPLETED USING THE REST OF THE FAULTY KITS AND AN ADDITIONAL AR-8988-CP FIBERLOCK SUSPENSION SYSTEM. THE CASE WAS DELAYED ONLY A FEW MINUTES, AND ANESTHESIA WAS ADMINISTERED FOR THE ADDED TIME.

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

  MAUDE report 21303951 ↗
• MalfunctionJan 29, 2025Break; Break

  ON 1/3/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FIBERTAK FROM AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM WOULD NOT ADVANCE IN THE CREATED TUNNEL; THE TIP BENT AND BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 1/8/2025: THE PERFORMED PROCEDURE WAS A CMC INTERNALBRACE. ALL THE BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE ANCHOR WAS NEVER IMPLANTED. THE REST OF THE INSTRUMENTS AND IMPLANTS FROM THE AR-8988-CP FIBERLOCK SUSPENSION SYSTEM INSTRUMENT AND IMPLANTS WERE USED. IN ADDITION TO THAT, ANOTHER AR-8988-CP FIBERLOCK SUSPENSION SYSTEM WAS OPENED TO USE THE FIBERTAK. THE CASE WAS DELAYED FIVE MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 21266008 ↗
• MalfunctionSep 19, 2024Break; Break

  ON 09/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE INSERTER FROM AN AR-8988-CP FIBERLOCK SUSPENSION IMPLANT KIT BROKE WITH LITTLE PRESSURE APPLIED. THE CASE WAS COMPLETED USING ANOTHER AR-8988-CP FIBERLOCK SUSPENSION IMPLANT KIT. THIS WAS DISCOVERED DURING A CMC SUSPENSIONPLASTY PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20260745 ↗
• MalfunctionJul 16, 2024Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM HAD AN ISSUE DURING A CMC ARTHROPLASTY PROCEDURE ON (B)(6) 2024. WHEN THE SURGEON WAS INSERTING THE ANCHOR, THE TRAJECTORY WAS GOOD, BUT THEN THE ANCHOR BENT WHEN IT WAS PARTIALLY THROUGH THE CANAL. EVERYTHING WAS REMOVED FROM THE PATIENT IN ONE PIECE, AND NOTHING BROKE INSIDE THE PATIENT. ANOTHER AR-8988-CP FIBERLOCK SUSPENSION SYSTEM WITH DIFFERENT LOT NUMBER 15102277 WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT HARM. THERE WAS NO CASE DELAY AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE COMPLAINT DEVICE WAS DISCARDED AND NO PICTURES WERE TAKEN. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750788 ↗
• MalfunctionJun 7, 2024Positioning Failure; Positioning Failure

  ON 4/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE DX FIBERTAK FROM AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM WOULD NOT SEAT. THE SURGEON FOLLOWED ALL THE TECHNIQUES CORRECTLY, DRILLED ACCORDINGLY, FOLLOWED THE LASER LINES, AND USED X-RAY FOR VISUALIZATION; HOWEVER, WHEN INSERTING THE DX FIBERTAK, STEP FOUR OF THE GUIDE, THE ANCHOR MET RESISTANCE AND WAS UNABLE TO ADVANCE PAST THE SECOND CORTEX. THE SURGEON CHANGED HAND POSITION AND TAPPED LIGHTLY, BUT THE FIBERTAK COULD NOT ENTIRELY BE INSERTED AND COULD ONLY BREACH A BIT OF THE SECOND CORTEX. ANOTHER AR-8988-CP FIBERLOCK SUSPENSION SYSTEM KIT WAS OPENED, AND THE SURGEON USED THE DX SWIVELOCK INSTEAD OF THE DX FIBERTAK TO COMPLETE THE PROCEDURE SUCCESSFULLY. THIS WAS DISCOVERED DURING A CMC SUSPENSIONPLASTY PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488212 ↗
• MalfunctionMay 1, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE IMPLANT INSERTER FROM AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM BENT UPON INSERTION. WHEN THE SURGEON MALLETED IT IN, THE TIP BROKE OFF. THE BROKEN PIECES WERE REMOVED, AND ANOTHER AR-8988-CP FIBERLOCK SUSPENSION SYSTEM WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A CMC ARTHROPLASTY PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/9/2024: THE FIBERTAK INSERTER BROKE DURING INSERTION. THE CASE WAS ONLY DELAYED BRIEFLY WHILE OPENING THE NEW KIT. ADDITIONAL ANESTHESIA WAS UNNECESSARY AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219649 ↗
• MalfunctionJan 23, 2024Fitting Problem; Fitting Problem

  ON 1/4/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM HAD AN ISSUE DURING A CMC SUSPENSION ARTHROPLASTY PROCEDURE ON (B)(6) 2024. UPON INSERTION, IT SEEMED THE ANCHOR WAS UNLOADING, AND THEY WERE ABLE TO RELOAD IT. THEY DRILLED AGAIN AND WENT THROUGH THE DISTAL CORTEX, BUT THE ANCHOR WOULD NOT SEAT AND KEPT PULLING THROUGH. NOTHING BROKE OFF INSIDE THE PATIENT. THE FIBERLOCK SUTURE ANCHOR AND THE SUTURES WERE REMOVED FROM THE PATIENT IN ONE PIECE. UPON REMOVAL, IT WAS NOTICED THAT THE DEVICE WAS BENT, BUT NOTHING HAD BROKEN OFF. ANOTHER AR-8988-CP FIBERLOCK SUSPENSION SYSTEM WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT HARM. THE CASE WAS DELAYED FOR JUST OVER 15 MINUTES, AND THE SALES REPRESENTATIVE COULD NOT CONFIRM IF ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563725 ↗
• MalfunctionSep 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 08/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM DRILL WOULD NOT TAKE THE PROPER DIRECTION INTO THE METACARPAL AND THE ANCHOR EXPERIENCED THE SAME ISSUE. THIS WAS DISCOVERED DURING A CASE, DEVIATION FROM INTENDED PROCEDURE. CASE COMPLETED USING A COMPETITOR PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 17754684 ↗
• MalfunctionAug 23, 2023Component Missing; Component Missing

  ON 7/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM WAS MISSING THE THREADED DRILL GUIDE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 8/1/2023: THIS WAS DISCOVERED DURING A CMC ARTHROPLASTY SUTURE ANCHOR SUSPENSIONPLASTY. THE CASE WAS COMPLETED USING ANOTHER AR-8988-CP FIBERLOCK SUSPENSION SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 17605652 ↗
• MalfunctionJan 16, 2023Break

  ON 12/29/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8988-CP FIBERLOCK SUSPENSION SYSTEMS NEEDLE TIP BROKE OFF. THIS OCCURRED DURING A CASE WHEN THE NEEDLE BROKE OFF INSIDE THE PATIENT, THE NEEDLE COULD NOT BE RETRIEVED. A X-RAY WAS TAKEN AND DID NOT SHOW THE NEEDLE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 16173476 ↗
• MalfunctionJan 16, 2023Break; Difficult to Remove

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM'S NEEDLE TIP BROKE OFF INSIDE THE PATIENT. CASE INVOLVEMENT, DEVICE BROKE DURING USE. NEEDLE WAS UNABLE TO BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16173470 ↗