Arthrex® AR-8979PRecalls & reported problems
Arthrex, Inc. · DX Swivelock, 3.5 x 13.5 mm · Class 2 · Implant
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867202900), received between Nov 13, 2018 and Sep 21, 2026 — classified as 2 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Defective Device3
- Device Dislodged or Dislocated2
- Fitting Problem2
- Entrapment of Device1
- Failure to Advance1
- Material Separation1
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information7
- No Clinical Signs, Symptoms or Conditions7
- Foreign Body In Patient1
- Pain1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Failure to Advance
On 7th September 2026, it was reported by a Distributor via an Email that for 1 unit of AR-8979P, DX Swivelock¿, 3.5 mm x 13.5 mm, it was unable to screw into the distal humerus bone during Tommy John Internal Brace procedure.This was detected during an UCL Internal Brace procedure on (b)(6) 2026. The procedure was completed successfully by using additional AR-8979P. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841327 ↗MalfunctionSep 9, 2025Fitting Problem; Fitting Problem
ON (B)(6) 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-8979P, DX SWIVELOCK¿, 3.5 MM X 13.5 MM, THE SWIVELOCK COULD NOT SCREW ALL THE THREAD INTO THE FIBULA. THE SURGEON TRIED TO PULL BACK AND INSERT AGAIN BUT FOUND THE EYELET WAS STUCK INSIDE THE FIBULA COULD NOT BE REMOVED. THIS WAS DETECTED DURING USE IN AN ATFL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL SWIVELOCK WAS USED. AR-1678-03, AR-1678-05 WERE USED AS DRILL AND TAP FOR THE FIBULAR HOLE. NO FURTHER ACTION OR SURGERY IS NEEDED BECAUSE OF THE ISSUE. BONE DENSITY TEST IS NOT A STANDARD PROTOCOL FOR ATFL CASE IN TAIWAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004957 ↗MalfunctionAug 18, 2025Break; Break
ON 31ST JULY 2025, IT WAS REPORTED BY AN DISTRIBUTOR VIA EMAIL THAT FOR 1 UNIT OF AR-8979P, DX SWIVELOCK¿, 3.5 MM X 13.5 MM, IT BROKE WHEN THE SURGEON WAS ROTATING IT DURING THE PROCEDURE. THIS WAS DETECTED DURING A ATFL + SYNDESMOSIS PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING IT TO ANOTHER AR-8979P. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22827478 ↗MalfunctionJul 7, 2025Defective Device; Defective Device
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-8979P DX SWIVELOCK DEVICES COULD NOT BE IMPLANTED PROPERLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 6/23/2025.
Patient problems: Insufficient Information
MAUDE report 22415976 ↗MalfunctionJul 7, 2025Defective Device; Defective Device
ON 6/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-8979P DX SWIVELOCK DEVICES COULD NOT BE IMPLANTED PROPERLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 6/23/2025.
Patient problems: Insufficient Information
MAUDE report 22415898 ↗MalfunctionJul 7, 2025Defective Device; Defective Device
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-8979P DX SWIVELOCK DEVICES COULD NOT BE IMPLANTED PROPERLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON6/23/2025.
Patient problems: Insufficient Information
MAUDE report 22415503 ↗InjuryJun 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2025, A HEALTHCARE PROFESSIONAL REPORTED THAT AN AR-3780SP KNEE FIBERTAK BUTTON, AN AR-8979P DX SWIVELOCK, AND AN AR-7500 SUTURETAPE WERE IMPLANTED IN A PATIENT DURING A SURGICAL PROCEDURE. APPROXIMATELY ONE YEAR LATER, THE PATIENT BEGAN EXPERIENCING PERSISTENT PAIN AND WAS REFERRED TO AN ALLERGIST FOR AN ALLERGEN PATCH TEST. NO ADDITIONAL DETAILS WERE PROVIDED.
Patient problems: Pain
MAUDE report 22125910 ↗MalfunctionApr 2, 2025Break; Break
ON 14TH MARCH 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-8979P, DX SWIVELOCK¿, 3.5 MM X 13.5 MM, AFTER IT WAS FULLY DEPLOYED, THE SURGEON TRIED THE TENSIONING AND THE IMPLANT CAME OUT. AFTER CHECKING THE IMPLANT HAD BROKEN. THIS WAS DETECTED DURING USE IN AN ELBOW EPICONDYLE REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY USED ANOTHER UNIT OF IMPLANT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21754003 ↗MalfunctionFeb 10, 2025Material Separation; Fitting Problem; Material Separation; Fitting Problem
ON 01/28/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8979P DX SWIVELOCKS BLADE SEPARATED FROM THE BODY. THIS OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21345292 ↗MalfunctionOct 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/3/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8979P DX SWIVELOCK ANCHOR WAS STUCK TO THE SHAFT AND COULD NOT BE INSERTED. THIS WAS DISCOVERED DURING A TENDON REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING A NEW ANCHOR. ATTEMPTING TO REMOVE THE ANCHOR FROM THE SHAFT DELAYED THE CASE FOR FIFTEEN TO TWENTY MINUTES.
Patient problems: Insufficient Information
MAUDE report 20428293 ↗MalfunctionApr 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 2/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8990ST FIBERTAK WAS INSERTED INTO THE PATIENT BUT THE ANCHOR DID NOT SEAT. SURGEON OPENED ANOTHER FIBERTAK AND IT WORKED PERFECTLY. DURING THE SAME PROCEDURE, AN AR-2324BCT-2 4.75 SWIVELOCK ANCHOR BROKE OFF INTO THE PATIENT'S BONE WHEN BEING INSERTER. SURGEON REMOVED ALL BROKEN FRAGMENTS AND OPENED ANOTHER 4.75 SWIVELOCK, HOWEVER, AFTER REMOVING THE INSERTER, THE ANCHOR PULLED OUT OF IMPLANTATION SITE. A THIRD SWIVELOCK WAS OPENED TO COMPLETE THAT PORTION OF THE PROCEDURE. THEN, WHILE USING AN AR-8979P DX SWIVELOCK, IT UNRAVELED FROM THE INSERTER AND PULLED OUT. SURGEON WAS ABLE TO USE ANOTHER SWIVELOCK TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILIZATION PROCEDURE ON (B)(6) 2022. NO FURTHER ISSUES HAS BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 19192115 ↗MalfunctionApr 18, 2024Break; Break
IT WAS REPORTED, THAT DURING A FOREFOOT TENDON REPAIR PROCEDURE, AS THE SURGEON WAS MALLETING THE AR-8979P, SWIVELOCK FOR INSERTION, THE ANCHOR BROKE INTO TWO PIECES. ALL BROKEN PIECES AND THE EYELET WERE REMOVED. THE SURGEON USED AR-8990ST TO DRILL AN ALTERNATE TUNNEL FOR INSERTION OF AR-8990ST. LOT: 11843584. THE CASE WAS COMPLETED WITH NO ADDITIONAL ISSUES, ADDING 15 EXTRA MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19132935 ↗MalfunctionApr 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 01/19/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-8979P SWIVELOCK ANCHOR PULLED OUT. THIS OCCURRED ON (B)(6) 2022 DURING A KINDER PROCEDURE WHEN THE SURGEON INSERTED THE ANCHOR INTO THE BONE AND IT INSERTED ACCORDINGLY, HOWEVER WHEN THE SUTURES WERE TIGHTENED THE ANCHOR PULLED OUT. THE SURGEON REMOVED ALL FRAGMENTS, AND COMPLETED THE CASE SUCCESSFULLY USING ANOTHER SWIVELOCK THEY HAD. THE BONE SOCKET WAS PREPPED USING A DRILL FROM THE AR-8979DS KIT, THE PATIENTS BONE QUALITY SEEMED GOOD. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19071271 ↗MalfunctionApr 4, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8979P DX SWIVELOCK ANCHOR BEGAN TO BEAK AND IT WAS REMOVED. CASE WAS COMPLETED USING A 4.5MM BIO-COMPOSITE SWIVELOCK ANCHOR WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A INTER-CUNEIFORM INSTABILITY IN A LISFRANC INTERNAL BRACE ON (B)(6) 2022
Patient problems: Insufficient Information
MAUDE report 13995079 ↗InjuryNov 13, 2018Entrapment of Device
IT WAS REPORTED THAT THE AR-8979P DX SWIVELOCK EYELET DISENGAGED BEFORE THE ANCHOR WAS INSERTED INTO THE BONE AND BECAME STUCK BENEATH THE CORTICAL BONE WITHIN THE CANAL, AND COULD NOT BE RETRIEVED DUE TO THE ANGLE IT WAS STUCK AT. THE REP STATED THIS OCCURRED BEFORE THE ANCHOR BODY WAS INSERTED INTO THE BONE SOCKET. A SECOND AR-8979P WAS INSERTED SUCCESSFULLY WITHOUT ANY ISSUE. THE REP STATED THAT THE BROKEN EYELET REMAINS SEATED BEHIND THE CORTICAL BONE IN THE ULNAR "OSSEAOUS" CANAL. THE BONE WAS PREPPED BY USING A 3.0 DRILL FROM AR-8979DS AT THE DESIGNATED DEPTH PER THE DEPTH GUIDE PROVIDED FROM KIT. A SINGLE LIMB OF LABRAL TAPE WAS INSERTED ALONG WITH THE ANCHOR TO FINISH THE IB CONSTRUCT. THE SCREW WAS INSERTED WITH THE DRIVER PRE-LOADED WITH THE ANCHOR. THE REP STATED THAT THE BONE QUALITY WAS VERY HARD. PATIENT; (B)(6) MALE.
Patient problems: Foreign Body In Patient
MAUDE report 8065526 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.