Arthrex® AR-8978PRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00888867193925), received between Aug 16, 2018 and Jul 10, 2026 — classified as 5 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Patient Device Interaction Problem

  ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) INDICATING THAT TWO AR-8978P DX SWIVELOCK SL IMPLANTS WITH FORKED EYELETS (3.5 X 8.5 MM) AND AN ARTHREX K-WIRE, IMPLANTED DURING A THUMB UCL REPAIR PROCEDURE ON (B)(6) 2026, ARE REPORTEDLY ASSOCIATED WITH A LINGERING INFECTION. CULTURE RESULTS WERE REPORTED AS CONSISTENT WITH OSTEOMYELITIS. THE ONSET OF SYMPTOMS INCLUDED WOUND DRAINAGE. TREATMENT WITH ANTIBIOTICS HAS BEEN INITIATED, AND A POTENTIAL REVISION PROCEDURE WITH HARDWARE REMOVAL HAS BEEN INDICATED. ADDITIONAL INFORMATION WAS RECEIVED ON 18-JUN-2026: THE PROCEDURE WAS PERFORMED ON THE PATIENT'S LEFT THUMB AND INVOLVED IMPLANTATION OF ARTHREX SUTURETAPE IN ADDITION TO THE PREVIOUSLY IDENTIFIED IMPLANTS. THE REPORTED OSTEOMYELITIS WAS ASSOCIATED WITH CULTURES POSITIVE FOR BOTH METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA) AND METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE REPORTER STATED THAT SYMPTOMS CONSISTENT WITH OSTEOMYELITIS BEGAN APPROXIMATELY ONE WEEK POSTOPERATIVELY AND REMAINED ONGOING AS OF THE REPORTING DATE. THE PATIENT WAS TREATED WITH ORAL AND LIQUID ANTIBIOTIC THERAPY. IMPLANT REMOVAL IS PLANNED; HOWEVER, NO REVISION PROCEDURE HAS BEEN P

  Patient problems: Foreign Body In Patient; Osteomyelitis

  MAUDE report 25780241 ↗
• MalfunctionFeb 24, 2026Break

  ON 13-FEB-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT A QTY. 2 OF AR-8978P DX SWIVELOCKS BROKE. IT WAS REPORTED THAT AT THE MOMENT OF ANCHOR INSERTION, ONE OF THE TIPS BROKE. THEN DURING INSERTION, ONE OF THE FORK TIPS BROKE. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH A THIRD ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430160 ↗
• MalfunctionFeb 24, 2026Break

  ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT A QTY. 2 OF AR-8978P DX SWIVELOCKS BROKE. IT WAS REPORTED THAT AT THE MOMENT OF ANCHOR INSERTION, ONE OF THE TIPS BROKE. THEN DURING INSERTION, ONE OF THE FORK TIPS BROKE. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH A THIRD ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430157 ↗
• MalfunctionFeb 6, 2026Device Dislodged or Dislocated

  ON 16-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8978P DX SWIVELOCK AND AN AR-8978DS-01 DISP KIT FOR DX SWIVELOCK WERE USED DURING AN ATFL REPAIR. THE AR-8978P FORK TIP WOULD NOT DISENGAGE AND PULLED OUT MULTIPLE TIMES. THIS WAS DISCOVERED DURING THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 24280185 ↗
• MalfunctionJan 21, 2026Break

  ON 06TH JAN 2026, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR A SWIVELOCK AR-8978P LOT 15219012 EYELET WAS BROKEN DURING SOCKET PREPARATION. THIS WAS DETECTED DURING USE IN A TFCC PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN ADDITIONAL SWIVELOCK & NO FRAGMENT WAS LEFT INSIDE THE PATIENT. BONE DENSITY TEST WAS NOT PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 24129965 ↗
• MalfunctionJan 5, 2026Break

  ON 15TH DECEMBER 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-8978P, DX SWIVELOCK® SL, WITH FORKED EYELET, 3.5X8.5MM, THE SWIVELOCK FORK TIP WAS BROKEN DURING INSERTION. THIS WAS DETECTED DURING USE IN A CMC ARTHRITIS PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL SWIVELOCK WAS USED. AR-8978DS-01 AND AR-1678-03 WERE USED FOR HOLE PREPARATION. BONE DENSITY TEST WAS NOT PERFORMED. NO FRAGMENT WAS LEFT INSIDE THE PATIENT. THE FORK TIP FRAGMENT WAS DROPPED ON THE FLOOR BUT COULD NOT BE FOUND AFTER SURGERY SO THE RETURNED IMPLANT WILL NOT HAVE THE TIP ON THE SWIVELOCK.

  Patient problems: Insufficient Information

  MAUDE report 23955636 ↗
• MalfunctionDec 17, 2025Break; Break

  ON 11/26/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8978P DX SWIVELOCK SL BROKE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER ANCHOR. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 12/03/2025: THIS INCIDENT OCCURRED DURING A DORSAL SCAPHOLUNATE REPAIR PROCEDURE. THE ANCHOR WAS REMOVED FROM THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED WITH AN AR-8978P DX SWIVELOCK SL. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED. NO PHOTOS WERE TAKEN OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23826531 ↗
• MalfunctionSep 8, 2025Separation Failure; Separation Failure

  ON 20TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-8978P, DX SWIVELOCK® SL, WITH FORKED EYELET, 3.5X8.5MM, THE SURGEON PULLED TO REMOVE THE ANCHOR BUT THE ANCHOR TIP DID NOT SEPARATE FROM THE SHAFT. THIS WAS DETECTED DURING A THUMB UCL PROCEDURE. THE CASE WAS DELAYED BY 5 MIN BUT WAS COMPLETED SUCCESSFULLY BY USING ANOTHER AR-8978P. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994645 ↗
• MalfunctionAug 1, 2025Positioning Failure; Physical Resistance/Sticking; Positioning Failure; Physical Resistance/Sticking

  ON 07/11/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-8978P DX SWIVELOCK SL WAS UNABLE TO RELEASE THE SCREW PORTION OF THE ANCHOR, AND THEY HAD TO PRY IT OFF BY HAND. THE CASE WAS COMPLETED, AND NO BREAKAGE OCCURRED INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A SCAPHOLUNATE INTERNAL BRACE PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/22/2025: A NEW AR-8978P WAS OPENED AND USED TO COMPLETE THE CASE SUCCESSFULLY. THE SURGERY WAS CARRIED OUT WITHOUT DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. A GOLD 3.5 MM DRILL FROM THE INTERNAL BRACE KIT PREPARED THE BONE SOCKET FOR IMPLANT INSERTION. THE PATIENT'S BONE QUALITY WAS ASSESSED AS FAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687541 ↗
• MalfunctionFeb 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A THUMB UCL BRACE SURGERY A PILOT HOLE WAS MADE. ANCHOR WAS PLACED AND UPON TESTING AT THE FIXATION, THE ANCHOR CAME OUT WITH THE EDGES AND THE ANCHOR FAILED. THE SURGEON HAD TO USE ANOTHER ANCHOR TO GET PROPER STABILITY. 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 21471127 ↗
• MalfunctionFeb 19, 2025Break; Break

  ON 02/05/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8978P DX SWIVELOCK SL FORKED TIP EYELET BROKE OFF INTO THE BONE WHEN THE SURGEON WAS DRILLING THE SECOND METACARPAL BASE TO INSERT THE ANCHOR. THE SURGEON HAD JUST GOTTEN THE TIP TO THE BONE AND STARTED TO PUSH THE ANCHOR WHEN THEY NOTICED THE BROKEN FORKED TIP. THEY OPENED A NEW ANCHOR, AND THE CASE PROCEEDED WITH LESS THAN A MINUTE OF ADDED TIME TO THE CASE. THIS WAS DISCOVERED DURING A CMC SUSPENSIONPLASTY PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 2/11/2025: ALL THE BROKEN FRAGMENTS WERE REMOVED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS OR SIGNIFICANT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412131 ↗
• MalfunctionOct 4, 2024Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION RECEIVED ON 10/4/2024: NOTHING BROKE IN THE PATIENT. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370172 ↗
• MalfunctionSep 16, 2024Break; Break

  ON 10/01/2024 ADDITIONAL INFORMATION WAS RECEIVED BY AN ARTHREX SUBSIDIARY EMPLOYEE WHO STATED THAT THE PROCEDURE PERFORMED WAS A RECONSTRUCTION OF THE LIGAMENT AND HIP JOINT. THE DEVICE BROKE AT THE TIME OF THE REPOSITIONING. THEY DID NOT TAKE PHOTOS OR VIDEO. AN ARTHREX REP WAS PRESENT. THE PATIENT'S BONE QUALITY WAS GOOD. THERE WAS NO NEED TO REPAIR THE PATIENT'S BONE CAVITY. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A NEW ANCHOR WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY AND NO NEED FOR ADDITIONAL ANESTHESIA.

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

  MAUDE report 20226013 ↗
• MalfunctionJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE DX SWIVELOCK ANCHOR, AR-8978P, WAS INSERTED INTO THE BONE, THE SURGEON PROPERLY SCREWED IN THE ANCHOR; HOWEVER, THE DRIVER OF THE DX SWIVELOCK WOULD NOT DISENGAGE FROM THE PEEK EYELET. BECAUSE THE EYELET WOULD NOT DISENGAGE, WHEN THE SURGEON TRIED TO REMOVE THE DRIVER, IT ENDED UP PULLING OUT THE ENTIRE ANCHOR OUT OF THE BONE. THE PROCESS OF INSERTING IT WAS REPEATED AND AGAIN, UPON TRYING TO DISENGAGE THE DRIVER, THE ENTIRE ANCHOR CONSTRUCT PULLED OUT. A DIFFERENT ANCHOR WAS OPENED AND USED TO DO THE PROCEDURE, DOING THE EXACT SAME STEPS OF THE TECHNIQUE, AND THIS ANCHOR WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558083 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 5/9/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8978P DX SWIVELOCK SL WITH A FORKED EYELET ANCHOR HAD THE FORK TIP BREAK OFF, AND THE SCREWS WOULD NOT RELEASE FROM THE METAL TIP OF THE MECHANISM. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED ON 5/20/2024: THIS WAS DISCOVERED DURING A UCL HAND PROCEDURE ON (B)(6) 2024. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS NO CASE DELAY. THE CASE WAS COMPLETED BY OPENING ANOTHER ANCHOR. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ADVERSE EFFECTS DUE TO THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19489739 ↗
• MalfunctionMay 17, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 04/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8978P DX SWIVELOCK SL FAILED. THE CASE WAS COMPLETED USING A NEW AR-8978P DX SWIVELOCK SL. THIS WAS DISCOVERED DURING A CMC PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/24/2024: THE PROCEDURE TOOK PLACE ON (B)(6) 2024. THE ANCHOR WAS COMPLETELY BENT WHEN THE R-8978P DX SWIVELOCK SL WAS PLACED. THE ANCHOR WAS RELOADED, BUT THE SAME THING HAPPENED. THE CASE WAS COMPLETED USING A NEW AR-8978P DX SWIVELOCK SL. NOTHING BROKE OFF INSIDE THE PATIENT, BUT THE EYELET BECAME LOOSE DURING INSERTION. THE CASE WAS DELAYED ONLY A FEW MINUTES. ADDITIONAL ANESTHESIA WAS UNNECESSARY, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342927 ↗
• MalfunctionMay 17, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 04/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8978P DX SWIVELOCK SL FAILED. THE CASE WAS COMPLETED USING A NEW AR-8978P DX SWIVELOCK SL. THIS WAS DISCOVERED DURING A CMC PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/24/2024: THE ANCHOR WAS COMPLETELY BENT WHEN THE AR-8978P DX SWIVELOCK SL WAS PLACED. THE ANCHOR WAS RELOADED, BUT THE SAME THING HAPPENED. THE CASE WAS COMPLETED USING A NEW AR-8978P DX SWIVELOCK SL. NOTHING BROKE OFF INSIDE THE PATIENT, BUT THE EYELET BECAME LOOSE DURING INSERTION. THE CASE WAS DELAYED ONLY A FEW MINUTES. ADDITIONAL ANESTHESIA WAS UNNECESSARY AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342892 ↗
• MalfunctionMay 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 04/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8978P SWIVELLOCK SUTURES PULLED OUT WHEN SURGEON WENT TO TIGHTEN. PROCEDURE COMPLETED USING ANOTHER ANCHOR. DELAY IN CASE 5 MINUTES. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220685 ↗
• MalfunctionApr 8, 2024Break; Break

  ON 01/03/2021, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-8978P DX SWIVELOCK SUTURES BROKE DURING FIXATION AND THE ANCHOR WAS LEFT IN THE BONE. THIS WAS DISCOVERED DURING A ARTHROPLASTY RESECTION TRAPEZIUS METACARPAL PROCEDURE ON (B)(6) 2021. SURGEON OPENED ANOTHER DEVICE AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 19064094 ↗
• MalfunctionMar 4, 2024Break; Break

  ON 2/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-8978P DX SWIVELOCK SL FAILED DURING A PROCEDURE. THE FIRST TWO BROKE AT THE FORKED TIP EYELET DURING INSERTION. ALL BROKEN FRAGMENTS WERE RETRIEVED. THE THIRD SWIVELOCK DID NOT BREAK; HOWEVER, THE EYELET WAS SOMEHOW DAMAGED WHICH WOULD NOT ALLOW THE ANCHOR TO BE IMPLANTED. THE SURGEON IS NOT SURE WHAT WAS WRONG WITH THE THIRD SWIVELOCK, BUT IT COULD NOT BE IMPLANTED. THIS WAS DISCOVERED DURING A CMC RECONSTRUCTION PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING A LARGER-SIZE SWIVELOCK. THE CASE WAS DELAYED LESS THAN FIFTEEN MINUTES, AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18830973 ↗
• MalfunctionMar 4, 2024Break; Break

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-8978P DX SWIVELOCK SL FAILED DURING A PROCEDURE. THE FIRST TWO BROKE AT THE FORKED TIP EYELET DURING INSERTION. ALL BROKEN FRAGMENTS WERE RETRIEVED. THE THIRD SWIVELOCK DID NOT BREAK; HOWEVER, THE EYELET WAS SOMEHOW DAMAGED WHICH WOULD NOT ALLOW THE ANCHOR TO BE IMPLANTED. THE SURGEON IS NOT SURE WHAT WAS WRONG WITH THE THIRD SWIVELOCK, BUT IT COULD NOT BE IMPLANTED. THIS WAS DISCOVERED DURING A CMC RECONSTRUCTION PROCEDURE ON (B)(6)2024. THE CASE WAS COMPLETED USING A LARGER-SIZE SWIVELOCK. THE CASE WAS DELAYED LESS THAN FIFTEEN MINUTES, AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18830968 ↗
• MalfunctionMar 4, 2024Break; Break

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-8978P DX SWIVELOCK SL FAILED DURING A PROCEDURE. THE FIRST TWO BROKE AT THE FORKED TIP EYELET DURING INSERTION. ALL BROKEN FRAGMENTS WERE RETRIEVED. THE THIRD SWIVELOCK DID NOT BREAK; HOWEVER, THE EYELET WAS SOMEHOW DAMAGED WHICH WOULD NOT ALLOW THE ANCHOR TO BE IMPLANTED. THE SURGEON IS NOT SURE WHAT WAS WRONG WITH THE THIRD SWIVELOCK, BUT IT COULD NOT BE IMPLANTED. THIS WAS DISCOVERED DURING A CMC RECONSTRUCTION PROCEDURE ON (B)(6)2024. THE CASE WAS COMPLETED USING A LARGER-SIZE SWIVELOCK. THE CASE WAS DELAYED LESS THAN FIFTEEN MINUTES, AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18830936 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A SCAPHOLUNATE RECONSTRUCTION SURGERY THE ANCHOR DOES NOT ENGAGE IN BONE BECAUSE IT IS COMPLETELY SEIZED, THERE'S NO SEPARATION BETWEEN THE SQUARE PART AND THE PEAR PART, WHEN SURGEON TRIED TO ENGAGE IT BROKE OFF. 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 18641116 ↗
• MalfunctionJan 29, 2024Defective Device; Defective Device

  ON 1/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE EYELET OF THE SWIVELOCK'S FROM AN AR-8978-CP HAND/WRIST INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM AND FROM AN AR-8978P DX SWIVELOCK WOULD NOT UNTHREAD OR WOULD NOT BECOME UNSCREWED. THE SURGEON ATTEMPTED MULTIPLE TIMES WITHOUT SUCCESS. THE CASE WAS COMPLETED USING ANOTHER AR-8978-CP HAND/WRIST INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM AND FROM AN AR-8978P DX SWIVELOCK. THIS WAS DISCOVERED DURING A SCAPHOLUNATE LIGAMENT RECONSTRUCTION ON (B)(6) 2024. THE PATIENT WAS NOT AFFECTED, AND THE CASE WAS ONLY DELAYED TO OPEN THE NEW IMPLANTS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597537 ↗
• MalfunctionNov 27, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 11/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8978P DX SWIVELOCK SL EYELET BENT DURING INSERTION AND IT WAS UNABLE TO CAPTURE THE SUTURE. THE CASE WAS COMPLETED USING A NEW AR-8978P DX SWIVELOCK SL FROM A DIFFERENT LOT NUMBER. NOTHING BROKE INSIDE THE PATIENT AND THERE WAS NO CASE DELAY. THIS WAS DISCOVERED DURING A UCL OF THE THUMB PROCEDURE ON 11/7/2023.

  Patient problems: Insufficient Information

  MAUDE report 18210809 ↗