Arthrex® AR-8717DS-0910Recalls & reported problems
Arthrex, Inc. · Dynanite NiTi Staple w/Instrs 9Wx10L · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867288058), received between May 14, 2020 and Oct 16, 2025 — classified as 3 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (10 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.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking10
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Damaged by Another Device1
- Failure to Advance1
- Fitting Problem1
- Material Fragmentation1
- Patient-Device Incompatibility1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions6
- Bacterial Infection2
- Discomfort2
- Pain2
- Swelling2
- Erythema1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/08/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE DRILL BIT FOR THE AR-8717DS-0910 DYNANITE NITINOL STAPLE IMPLANT SYSTEM DID NOT FIT THROUGH THE GUIDE AND WAS COLD-WELDED TO IT. WHEN THIS OCCURRED, THE DRILL JERKED AND SLIPPED OUT OF THE PHYSICIAN¿S HANDS. NO FURTHER DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/09/2025.
Patient problems: Insufficient Information
MAUDE report 23316782 ↗MalfunctionJul 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 06/09/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THE AR-8717DS-0910 DYNANITE NITINOL STAPLE IMPLANT SYSTEM HAD THE DRILL BIT STUCK IN THE DRILL GUIDE. THE CASE WAS COMPLETED USING ANOTHER AR-8717DS-0910 DYNANITE NITINOL STAPLE IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 06/23/2025: THIS EVENT OCCURRED IN A FOUR-CORNER FUSION PROCEDURE ON (B)(6) 2025. NO DELAYS WERE REPORTED, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED DURING THE SURGERY. THERE WERE NO INSTANCES OF INSTRUMENT OR IMPLANT BREAKAGE, AND THEREFORE, NO FRAGMENTS NEEDED TO BE RETRIEVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR SIGNIFICANT DAMAGE DURING OR AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385891 ↗MalfunctionSep 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2024 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE DRILL FROM AN AR-8717DS-0910 DYNANITE NITINOL STAPLE IMPLANT SYSTEM GOT STUCK TO THE SLEEVE AND COULD NOT BE USED. THE CASE WAS COMPLETED USING A NEW AR-8717DS-0910 DYNANITE NITINOL STAPLE IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024 .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20246642 ↗MalfunctionAug 12, 2024Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT DURING AN AKIN TECHNOLOGY SURGERY WITH DYNANITE STAPLES THE DRILL BIT WELDED ITSELF TO THE DRILL GUIDE DURING DRILLING. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19966898 ↗MalfunctionJul 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING AN AKIN-TECHNOLOGY WITH THE DYNANITE CLAMPS THE DRILL BIT IS COLD-WELDED IN SLEEVE DURING DRILLING. THEREFORE THE DRILL AND SLEEVE COULD NOT BE USED ANYMORE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DRILL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. T WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19816122 ↗MalfunctionMay 23, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 03/29/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA PHONE THAT ON (B)(6) 2022 DURING A 4 CORNER FUSION A AR-8717DS-1110 DYNANITE STAPLE IMPLANT SYSTEMS DRILL BIT GOT BOUND UP IN THE DRILL GUIDE. THEN FOLLOWING THIS AN AR-8717DS-0910 DYNANITE STAPLE IMPLANT SYSTEMS DRILL BIT ALSO GOT BOUND UP IN THE DRILL GUIDE. THE SURGEON PROCEEDED TO GET 2 NEW KITS AND THOSE WORKED ACCORDINGLY. A AR-8717G-01 DRILL GUIDE, AND A AR-8717G-02 DRILL GUIDE ALSO GOT BOUND UP. THE CASE WAS COMPLETED HOWEVER THE SURGEON WAS NOT PLEASED WITH THE PLACEMENT.
Patient problems: Insufficient Information
MAUDE report 19380844 ↗MalfunctionMay 1, 2024Failure to Advance; Failure to Advance
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8717DS-0910 DYNANITE¿ NITINOL STAPLE IMPLANT SYSTEMS GUIDE WOULD NOT ADVANCE THROUGH THE DRILL. THIS OCCURRED DURING A BUNIONECTOMY ON (B)(6) 2024 WHILE THE GUIDE WAS IN THE PATIENT, WHEN TRYING TO ADVANCE THE DRILL, IT WAS STUCK. THE CASE CONTINUED USING ANOTHER AR-8717DS-0910.
Patient problems: Insufficient Information
MAUDE report 19219543 ↗MalfunctionApr 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 3/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE DRILL BIT FROM AN AR-8717DS-0910 DYNANITE NITINOL STAPLE IMPLANT SYSTEM COLD WELDED TO THE GUIDE AND COULD NOT BE USED. THIS WAS DISCOVERED DURING AN AKIN OSTEOTOMY PROCEDURE ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 19148748 ↗MalfunctionFeb 27, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 2/8/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8717DS-0910 DYNANITE NITINOL STAPLE IMPLANT SYSTEM DRILL GUIDE GOT STUCK IN THE GUIDE. THE CASE WAS COMPLETED USING ANOTHER AR-8717DS-0910 FROM A DIFFERENT LOT WITH NO ISSUES. NO PIECES BROKE INSIDE THE PATIENT, AND NO CASE DELAY WAS REPORTED. THIS WAS DISCOVERED DURING AN AKIN OSTEOTOMY PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793578 ↗MalfunctionFeb 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 01/16/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8717DS-0910 DRILL WAS DIFFICULT TO THROUGH THE DRILL GUIDE. THE CASE WAS COMPLETED WITH A NEW PRODUCT OF THE SAME CATALOG NUMBER. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18660741 ↗MalfunctionOct 27, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE DRILL AND DRILL GUIDE FROM AN AR-8717DS-0910 DYNANITE NITINOL STAPLE IMPLANT SYSTEM GOT STUCK. THIS WAS DISCOVERED DURING A BUNION AKIN PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18022576 ↗MalfunctionJun 26, 2023Material Fragmentation; Material Fragmentation
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8717DS-0910 DYNANITE NITINOL STAPLE IMPLANT SYSTEM DRILL PRODUCES DEBRIS DURING DRILLING. THIS WAS DISCOVERED DURING A BUNION WITH AKIN PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17199051 ↗MalfunctionFeb 28, 2022Break
ON (B)(6) 2021, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA E-MAIL THAT A AR-8717DS-0910 DYNANITE IS DAMAGED. THIS OCCURRED DURING AN UNKNOWN PROCEDURE WHEN USED NORMALLY, THE DOLLAR PART WAS DAMAGED. THE CASE WAS COMPLETED USING A NEW PRODUCT. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 12/23/2021: THE PROCEDURE BEING PERFORMED WAS A AKIN OSTEOTOMY. THE DRILL WAS DAMAGED IN THE GUIDE, ALL DEBRIS PRODUCED WAS REMOVED. A NEW DRILL OF AN UNKNOWN PART NUMBER WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 13620520 ↗MalfunctionOct 28, 2020Physical Resistance/Sticking
DURING ADMINISTRATION OF THE STAPLE TO THE AFFECTED TOE THE DRILL BIT BECAME LODGED IN THE SKIN PROTECTOR SHEATH. DRILL BIT BECAME PERMANENTLY STUCK.
Patient problems: Insufficient Information
MAUDE report 10747063 ↗InjuryAug 5, 2020Fitting Problem
IT WAS REPORTED THAT THE DRILL WOULD NOT FIT THROUGH THE DRILL GUIDE WITHIN THE AR-8717DS-0910 DYNANITE NITINOL STAPLE IMPLANT SYSTEM. THE SURGEON USED SCREW FIXATION INSTEAD OF STAPLE FIXATION TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10367017 ↗InjuryMay 14, 2020Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A PATIENT HAD A BUNION CORRECTION SURGERY ON (B)(6) 2020. DURING THE SURGERY, THE SURGEON IMPLANTED AR-8717DS-0910 DYNANITE NITI STAPLE (LOT: 926197317) TO FIX THE OSTEOTOMY. THE PATIENT EXPERIENCED INFECTION AND SWELLING POST OP. THE SURGEON TREATED THE PATIENT WITH ROUNDS OF ANTIBIOTICS, BEFORE ULTIMATELY DECIDING TO PERFORM A HARDWARE REMOVAL. THE REP REPORTED THAT THE REMOVAL SURGERY HAS NOT TAKEN PLACE AS OF YET, AND IS ON THE SCHEDULE. ADDITIONAL INFORMATION RECEIVED ON 4/29/2020: THE SALES REP REPORTED AR-8717DS-0910 (LOT: 926197317) WAS THE ONLY ARTHREX PRODUCT IMPLANTED DURING THE PRIMARY SURGERY. THE REVISION SURGERY HAS NOT YET BEEN SCHEDULED. THE SURGEON DOES NOT PLAN TO IMPLANT ANY ADDITIONAL ARTHREX HARDWARE DURING THE UPCOMING REVISION SURGERY. THE PATIENT STARTED EXPERIENCING A REACTION/PAIN AND DISCOMFORT ON (B)(6) 2020. THE PATIENT IS EXPERIENCING SWELLING AND REDNESS. CULTURES WERE TAKEN, AND THE PATIENT TESTED POSITIVE FOR STAPHYLOCOCCUS AND E.COLI. THERE ARE NO DE-IDENTIFIED X-RAY COPIES AVAILABLE.
Patient problems: Bacterial Infection; Discomfort; Erythema; Pain; Reaction; Swelling
MAUDE report 10055750 ↗InjuryMay 14, 2020Patient-Device Incompatibility
IT WAS REPORTED THAT A PATIENT HAD A BUNION CORRECTION SURGERY ON (B)(6) 2020. DURING THE SURGERY, THE SURGEON IMPLANTED AR-8717DS-0910 DYNANITE NITI STAPLE (LOT: 926197317) TO FIX THE OSTEOTOMY. THE PATIENT EXPERIENCED INFECTION AND SWELLING POST OP. THE SURGEON TREATED THE PATIENT WITH ROUNDS OF ANTIBIOTICS, BEFORE ULTIMATELY DECIDING TO PERFORM A HARDWARE REMOVAL. THE REMOVAL PROCEDURE TOOK PLACE ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE PRIMARY SURGERY, AND TOOK PLACE AT THE SAME FACILITY. THERE WAS NO NEED FOR ADDITIONAL HARDWARE AS THE FUSION SITE HAD HEALED AND THERE WAS NO INFECTION IN THE BONE, JUST SURROUNDING SOFT TISSUE WHICH WAS SENT FOR BIOPSY. THE REP REPORTED THE BONE WAS NOT AFFECTED DURING THIS PROCEDURE, AND ACTUALLY HAD A GREAT FUSION. ADDITIONAL INFORMATION RECEIVED ON 4/29/2020: IT WAS REPORTED THAT AR-8717DS-0910 (LOT: 926197317) WAS THE ONLY ARTHREX PRODUCT IMPLANTED DURING THE PRIMARY SURGERY, AND THE ONLY ARTHREX PRODUCT REMOVED DURING THE REVISION SURGERY. THE PATIENT STARTED EXPERIENCING A REACTION/PAIN AND DISCOMFORT ON (B)(6) 2020. THE PATIENT WAS EXPERIENCING REDNESS AND SWELLING. CULTURES WERE TAKEN IN O
Patient problems: Bacterial Infection; Discomfort; Pain; Swelling
MAUDE report 10055733 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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