Arthrex® AR-1317FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00888867276703), received between Apr 27, 2018 and Sep 17, 2026 — classified as 9 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Break” (50 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 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  On (b)(6) 2026, a sales representative reported via phone that an AR-1317FT nano corkscrew's driver tines at the top of the shaft broke off. Piece broke off into patient and retrieved, new device opened and case completed with no patient effect.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804177 ↗
• MalfunctionSep 15, 2026Break

  On 31st August 2026, it was reported by an Arthrex employee via email that for 2 units of AR-1317FT, Suture Anchor, Nano Corkscrew® FT, Ti, w 3-0 FW, the anchor portion of the Nano Corkscrew FT 1.7mm fractured during insertion into the body. This was detected during use in an unknown procedure on (b)(6) 2026. The procedure was completed successfully by using a product with the same part number.No significant surgery delay reported. All of the product/fragment was removed and nothing remains in the patient. No additional anesthesia administered to the patient. No information about an instrument used to prepare/tap the bone socket for insertion of the implant. Bone quality of the patient is unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777639 ↗
• MalfunctionSep 15, 2026Break

  On 31st August 2026, it was reported by an Arthrex employee via email that for 2 units of AR-1317FT, Suture Anchor, Nano Corkscrew® FT, Ti, w 3-0 FW, the anchor portion of the Nano Corkscrew FT 1.7mm fractured during insertion into the body. This was detected during use in an unknown procedure on (b)(6) 2026. The procedure was completed successfully by using a product with the same part number.No significant surgery delay reported. All of the product/fragment was removed and nothing remains in the patient. No additional anesthesia administered to the patient. No information about an instrument used to prepare/tap the bone socket for insertion of the implant. Bone quality of the patient is unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774822 ↗
• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50054861 ↗
• MalfunctionDec 9, 2025Break; Break

  ON 11/19/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THE SCREW FROM AN AR-1317FT NANO CORKSCREW FT SUTURE ANCHOR BROKE DURING SURGERY. ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-1317FT NANO CORKSCREW FT SUTURE ANCHOR. NO SPECIFIC DETAILS WERE PROVIDED REGARDING THE TYPE OF SURGERY, BONE PREPARATION, OR BONE QUALITY. THERE WAS NO SIGNIFICANT DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO ADVERSE EFFECTS NOTED. NO PHOTOGRAPHS WERE TAKEN TO DOCUMENT THE EVENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 11/25/2025: THIS ISSUE OCCURRED DURING THE INSERTION OF THE ANCHOR INTO THE BONE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757226 ↗
• MalfunctionDec 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/10/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1322BCNF MINI BIOCOMPOSITE SUTURETAK WAS IMPLANTED IN A PATIENT PAST ITS EXPIRATION DATE. DURING THE PROCEDURE, AN ANCHOR PULLED OUT, REQUIRING AN INCREASE IN ANCHOR SIZE. UNFORTUNATELY, THE ONLY AVAILABLE OPTIONS IN THE SHELF INVENTORY WERE EXPIRED, AND THE SURGEON DECIDED TO PROCEED WITH IMPLANTING THE EXPIRED DEVICE. THIS OCCURRED DURING A METACARPAL FRACTURE/UCL PROCEDURE PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION WAS PROVIDED VIA EMAIL ON 11/19/2025: THE ANCHOR THAT PULLED OUT WAS AN AR-1317FT NANO CORKSCREW FT. THE ANCHOR WAS COMPLETELY REMOVED FROM THE PATIENT BEFORE PROCEEDING TO PLACE THE EXPIRED IMPLANT. THIS ADDED AN EXTRA 5¿10 MINUTES TO THE CASE. DUE TO THE EXTENDED CASE TIME, ADDITIONAL ANESTHESIA WAS POSSIBLY ADMINISTERED, BUT THE SALES REPRESENTATIVE COULD NOT CONFIRM.

  Patient problems: Insufficient Information

  MAUDE report 23680720 ↗
• MalfunctionOct 22, 2025Break; Break

  ON 10/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1317FT NANO CORKSCREW EYELET SHEARED OFF DURING IMPLANTATION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO CASE DELAY AND CASE WAS COMPLETED USING ANOTHER CORKSCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356540 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A FINGER LIGAMENT SURGERY THE ANCHOR BROKE IN THE PATIENT. THE SURGEON MANAGED TO REMOVE ALL FRAGMENTS FROM THE PATIENT. 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 23018795 ↗
• MalfunctionAug 6, 2025Break; Break

  ON 07/18/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE TRAILING END OF AN AR-1317FT NANO CORKSCREW FT ANCHOR BROKE, LEAVING IT PROUD AND UNABLE TO BE ADVANCED FURTHER. THE SOCKET WAS PREPARED USING THE INCLUDED 1.6MM WIRE AND THE ANCHOR WAS REMOVED WITH THE AID OF A TREPHINE. THE PROCEDURE WAS COMPLETED WITH TWO ALTERNATIVE ANCHORS AND NO ADVERSE EFFECTS WERE REPORTED FOR THE PATIENT. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 7/23/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729553 ↗
• MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 05/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1317FT SUTURE ANCHOR CAME OFF THE INSERTER. THIS OCCURRED DURING AN ACL REPAIR ON (B)(6) 2025. THE ANCHOR CAME OFF THE DEPLOYMENT OF THE INSERTER, SEVERING THE SUTURES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED USING A DIFFERENT ANCHOR. THIS CAUSED A DELAY OF 15 MINUTES. THERE WAS NO ADDITIONAL ANESTHESIA ADMINISTERED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293800 ↗
• MalfunctionMay 12, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/12/2025: DURING THE PROCEDURE, THE ANCHOR DETACHED IMMEDIATELY UPON INSERTION. THE ANCHOR REMAINED INTACT UPON REMOVAL, BUT THE SUTURE WAS BROKEN. DUE TO INSUFFICIENT TISSUE FOR SUTURING, THE PROCEDURE ON THE LUNATE BONE WAS ABANDONED, AND IT WAS DETERMINED THAT SURGERY COULD BE COMPLETED USING ANCHORS IN OTHER AREAS. NO ADDITIONAL IMPLANTS OR SUTURES WERE USED TO COMPENSATE FOR THE ANCHOR LOSS. ALL BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THOUGH SPECIFIC PRODUCT DETAILS REMAIN UNKNOWN, A 1.1MM GUIDEWIRE WAS USED TO DRILL THE PILOT HOLE. NO INFORMATION WAS PROVIDED REGARDING THE PATIENT'S BONE QUALITY. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT HAS NOT EXPERIENCED COMPLICATIONS POSTOPERATIVELY, AND NO FURTHER SURGERY IS PLANNED. NO ADDITIONAL MEDICAL INTERVENTION OR HOSPITALIZATION WAS REQUIRED. THE DEVIATION DID NOT REDUCE THE PATIENT'S QUALITY OF LIFE. NO IMAGES OR VIDEOS OF THE COMPLAINT DEVICE WERE AVAILABLE. THE PATIENT'S CURRENT HEALTH STATUS REMAINS STABLE, WITH NO REPORTED POSTOPERATIVE CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001570 ↗
• MalfunctionApr 23, 2025Break; Break

  AR-1317FT SUTURE ANCHOR (LOT: 15122984) WAS USED, AND ONCE IT WAS RELEASED FOR IMPLANTATION, THE INSERTER HAD THE TITANIUM ANCHOR FALLING APART INTO FRAGMENTS, WHICH THEN FRAYED THE SUTURE IN THAT AREA AND HAD TO PULL OUT THE SUTURE. THE ANCHOR FALLS INTO SMALLER PIECES BEFORE ATTEMPTING TO TAKE IT OUT. ALL PIECES OF THE ANCHOR AND FRAYED SUTURE WERE REMOVED FROM THE PATIENT. AN AR-1318FT WAS USED TO GO UP A SIZE TO COMPLETE THE CASE. THE CASE WAS DELAYED LESS THAN 15 MINUTES. NO ADDED ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED. THIS WAS DISCOVERED DURING A SCAPHOLUNATE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891694 ↗
• MalfunctionJan 14, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 1/27/2024: THIS WAS DISCOVERED DURING A MATERNAL FINGER UCL INJURY PROCEDURE. THE ANCHOR WAS REMOVED FROM THE PATIENT ALONG WITH ANY BROKEN FRAGMENTS. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

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

  MAUDE report 21151807 ↗
• MalfunctionJul 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 06/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-1317FT SUTURE ANCHORS PLASTIC INSERT HOLDING THE SCREW ON WOULD NOT SLIDE UP. THIS OCCURRED DURING A TISSUE REPAIR ON (B)(6) 2024 THE SURGEON WENT TO GO INSERT THE ANCHOR AND THE PLASTIC INSERT HOLDING THE SCREW ON WOULD NOT SLIDE UP. THE SURGEON TRIED TO BACK THE SCREW UP A LITTLE TO SEE IF THAT WOULD RELEASE THE PLASTIC, BUT IT STILL WAS STUCK TO THE INSERTER. SHE ENDED UP JUST ADVANCING THE SCREW ALL THE WAY AND PULLING ON THE PLASTIC, WHICH THEN, CAUSED PARTS OF THE METAL SCREW TO FRAY OFF. THE ANCHOR AND METAL PIECES WERE REMOVED FROM THE PATIENT, AND A NEW CORKSCREW WAS INSERTED JUST FINE. ADDITIONAL INFORMATION RECEIVED ON 6/18/2024: EVERYTHING WAS REMOVED FROM THE PATIENT AND THE CASE WAS COMPLETED USING A NEW AR-1317FT NANO CORKSCREW FT.

  Patient problems: Insufficient Information

  MAUDE report 19688513 ↗
• MalfunctionJun 17, 2024Break; Break

  ON 5/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 2) OF AN AR-1317FT SUTURE ANCHOR, NANO CORKSCREW HAD THE INSERTER AND TOP THREAD OF THE TITANIUM ANCHOR BREAK INTO A VERY TINY PIECE THAT REMAINED OUTSIDE OF THE PATIENT AND NOTHING NEEDED TO BE REMOVED FROM THE PATIENT. THIS ISSUE OCCURRED WHEN INSERTING THE ANCHOR ALL THE WAY. THE TWO ANCHORS STAYED IN THE PATIENT, AND THE STRUCTURAL INTEGRITY OF THE IMPLANT WAS NOT AFFECTED. THE CASE WAS COMPLETED SUCCESSFULLY, AND NOTHING NEEDED TO BE IMPLANTED AFTER WITH NO DELAY IN THE CASE REPORTED. THIS WAS DISCOVERED DURING A REPAIR OF BOUTONNIERE DEFORMITY ON THE RIGHT-HAND RING FINGER ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19553726 ↗
• MalfunctionJun 17, 2024Break; Break

  ON 5/21/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 2) OF AN AR-1317FT SUTURE ANCHOR, NANO CORKSCREW HAD THE INSERTER AND TOP THREAD OF THE TITANIUM ANCHOR BREAK INTO A VERY TINY PIECE THAT REMAINED OUTSIDE OF THE PATIENT AND NOTHING NEEDED TO BE REMOVED FROM THE PATIENT. THIS ISSUE OCCURRED WHEN INSERTING THE ANCHOR ALL THE WAY. THE TWO ANCHORS STAYED IN THE PATIENT, AND THE STRUCTURAL INTEGRITY OF THE IMPLANT WAS NOT AFFECTED. THE CASE WAS COMPLETED SUCCESSFULLY, AND NOTHING NEEDED TO BE IMPLANTED AFTER WITH NO DELAY IN THE CASE REPORTED. THIS WAS DISCOVERED DURING A REPAIR OF BOUTONNIERE DEFORMITY ON THE RIGHT-HAND RING FINGER ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19553597 ↗
• MalfunctionJun 4, 2024Break; Break

  ON 05/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (3) AR-1317FT NANO CORKSCREW AND AN AR-1318FT MICRO CORKSCREWS IMPLANT HEAD BROKE DURING INSERTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED DRILLING BONE TUNNELS TO SECURE LUNATE. DELAY IN CASE 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463746 ↗
• MalfunctionJun 4, 2024Break; Break

  ON 05/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (3) AR-1317FT NANO CORKSCREW AND AN AR-1318FT MICRO CORKSCREWS IMPLANT HEAD BROKE DURING INSERTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED DRILLING BONE TUNNELS TO SECURE LUNATE. DELAY IN CASE 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463707 ↗
• MalfunctionJun 4, 2024Break; Break

  ON 05/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (3) AR-1317FT NANO CORKSCREW AND AN AR-1318FT MICRO CORKSCREWS IMPLANT HEAD BROKE DURING INSERTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED DRILLING BONE TUNNELS TO SECURE LUNATE. DELAY IN CASE 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463668 ↗
• MalfunctionMay 28, 2024Break; Break

  ON 4/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1317FT NANO CORKSCREW BROKE ON THE FIRST TWIST DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE REMOVED. ANOTHER 1.7X5 CORKSCREW WAS IMPLANTED; HOWEVER, AN X-RAY DETERMINED THAT ONE WAS TOO LONG. THE SURGEON COMPLETED THE CASE AS A BONE TUNNEL INSTEAD OF AN ANCHOR. THIS WAS DISCOVERED DURING A MIDDLE FINGER SOFT TISSUE REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED ABOUT THREE MINUTES. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19403658 ↗
• MalfunctionMay 9, 2024Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6)2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (2) AR-1317FT NANO CORKSCREW AND (2) AR-1318FT-40 MICRO SUTURE ANCHOR CORKSCREW TIPS BENT WHILE INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2021, WHEN SURGEON MADE A PILOT HOLE, AR-1317FT TIP BENT AND THE BONE QUALITY WAS HARD. THIS WAS ATTEMPTED AGAIN WITH ANOTHER NANO CORKSCREW AND THE DRIVER TIP BENT WHEN IT WAS ABOUT 80% INSERTED. THE SAME HAPPENED WHEN AR-1318FT-40 SCREW WAS INSERTED. FINALLY, SURGEON WAS ABLE TO INSERT AND SUTURE ONE NANO AND ONE MICRO CORKSCREW TO COMPLETE CASE. ADDITIONAL INFORMATION RECEIVED 10/11/2021 SURGEON TRIED TO USE ANOTHER AR-1318FT-40 A SECOND TIME AND TIP WAS ALSO BENT. THERE WERE NO BROKEN PIECES INSIDE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19275382 ↗
• MalfunctionMay 6, 2024Component Missing; Component Missing

  ON 9/9/2021 IT WAS REPORTED BY SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1317FT SUTURE ANCHOR, NANO CORKSCREW® FT, TI, W 3-0 F WAS MISSING ANCHOR FROM THE INSERTER. THIS WAS DISCOVERED DURING A PROCEDURE BUT PACKAGE WAS NEVER OPENED OR USED ON PATIENT. ADDITIONAL INFORMATION RECEIVED 9/9/2021 DEVICE WAS NO NEEDED IN THE CASE AND WILL BE RETURNED TO OUR FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 19255786 ↗
• MalfunctionJan 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1317FT ANCHORS RIPPED OFF DURING INSERTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. FINISHED THE CASE WITH A MITEK PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552536 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 01/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1317FT ANCHORS RIPPED OFF DURING INSERTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. FINISHED THE CASE WITH A MITEK PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552111 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 01/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1317FT ANCHORS RIPPED OFF DURING INSERTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. FINISHED THE CASE WITH A MITEK PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552109 ↗