Arthrex® AR-7715Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867220980), received between Dec 26, 2019 and Mar 25, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Component Missing; Material Deformation

  ON 04-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT ONE OF THE SWIVELOCKS FROM AN AR-7715 UCL INTERNALBRACE IMPLANT SYSTEM WAS MISSING THE ANCHOR AND INCLUDED ONLY AN EYELET. ADDITIONALLY, DURING THE PROCEDURE, THE DRILL GUIDE WARPED. THIS ISSUE WAS DISCOVERED DURING A UCL REPAIR WITH INTERNALBRACE PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 09-MAR-2026: THE DRILL GUIDE WARPED GRADUALLY WHILE DRILLING THE PILOT HOLE FOR THE FIRST ANCHOR IN THE HUMERUS. THE DEFORMATION WAS LIMITED TO WARPING, WITH NO CHIPPING OR MATERIAL LOSS OBSERVED. THE PROCEDURE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 24690442 ↗
• MalfunctionFeb 3, 2026Break

  ON 13-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-7715 UCL INTERNALBRACE IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING USE. SPECIFICALLY, THE DRILL BECAME CROSS-THREADED WITH THE DRILL GUIDE, RESULTING IN THE GUIDE SNAPPING. THE ISSUE OCCURRED DURING A UCL INTERNALBRACE PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-JAN-2026: THE ISSUE OCCURRED INTRAOPERATIVELY AT THE SURGICAL SITE WHEN THE SURGEON-INITIATED DRILLING FOR THE FIRST ANCHOR HOLE. ALTHOUGH THE PATIENT¿S BONE QUALITY WAS DESCRIBED AS GOOD AND YOUNG, THE DRILL BIT CROSS-THREADED ALMOST IMMEDIATELY UPON CONTACTING THE PATIENT'S CORTEX. NO PRODUCT FRAGMENTS WERE GENERATED WHEN THE DRILL GUIDE SNAPPED. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL AR-7715 UCL INTERNALBRACE IMPLANT SYSTEM. THE CASE WAS DELAYED APPROXIMATELY THREE MINUTES WHILE THE REPLACEMENT KIT WAS RETRIEVED. NO ADDITIONAL ANESTHESIA WAS REQUIRED, AND NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248104 ↗
• MalfunctionJun 18, 2025Material Fragmentation; Material Fragmentation

  ON 5/27/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT METAL SHAVINGS WERE FOUND AFTER DRILLING THE SOCKETS FOR THE SWIVELOCKS IN THE AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM. THE ISSUE APPEARS TO OCCUR BECAUSE THE DRILL FLUTES EXTEND PAST THE SOFT TISSUE GUIDE, MAKING CONTACT WITH THE TOP OF THE GUIDE IF THEY ARE NOT PERFECTLY ALIGNED. THIS ISSUE ADDED SOME UNDESIRABLE RISK AND TIME TO THE CASE. PER THE SALES REPRESENTATIVE, NO FURTHER INFORMATION IS KNOWN ABOUT THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22287445 ↗
• MalfunctionMar 20, 2025Break; Break

  ON 03/06/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM HAD TWO ANCHORS STRIPPED AND BROKE WHEN TRYING TO INSERT INTO THE BONE. ALL PIECES OF THE ANCHORS WERE REMOVED FROM THE PATIENT. THERE WAS AN UNDER 15-MINUTE DELAY IN THE CASE WITH NO ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. A SECOND KIT FROM THE SAME LOT SUCCESSFULLY COMPLETED THE CASE. THIS WAS DISCOVERED DURING AN ELBOW UCL PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21652283 ↗
• MalfunctionOct 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 10/1/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT BOTH PEEK SWIVELOCK EYELETS FROM AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM WERE NOT ON THE INSERTER SHAFT, AND BOTH FELL OFF WHILE ATTEMPTING TO LOAD THE SUTURE ONTO THEM. THE CASE WAS COMPLETED USING ANOTHER AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 10/3/2024: THIS WAS DISCOVERED DURING AN ELBOW UCL IB PROCEDURE ON (B)(6) 2024. THE ISSUE OCCURRED JUST PRIOR TO THE ANCHOR INSERTION. THE CASE WAS COMPLETED USING A NEW AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473120 ↗
• MalfunctionJun 28, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE ANCHOR OF ONE OF THE SWIVELOCKS FROM AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM WOULD NOT ADVANCE DOWN UNTIL IT WAS FLUSH WITH THE BONE. THE SURGEON REMOVED THE PARTIALLY INSERTED ANCHOR, BUT THE ANCHOR BODY WOULD NOT SLIDE BACK UP THE INSERTER TO BE RE-DEPLOYED. THE CASE WAS COMPLETED USING A 3.5 SWIVELOCK. THIS WAS DISCOVERED DURING AN ELBOW UCL REPAIR PROCEDURE ON (B)(6) 224.

  Patient problems: Insufficient Information

  MAUDE report 19632331 ↗
• MalfunctionJun 25, 2024Break; Break

  ON 05/31/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ONE OF THE SWIVELOCKS FROM AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM BROKE DURING INSERTION. ALL BROKEN FRAGMENTS WERE REMOVED. THE BONE WAS PREPPED WITH THE DRILL AND TAP FROM THE KIT. THE CASE WAS COMPLETED BY OPENING ANOTHER AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM. THE DRILL WAS USED AGAIN AND CYCLED MULTIPLE TIMES. A LARGER TAP WAS USED, DOUBLE TAPPING, AND WAS LEFT TO REST IN THE HOLE FOR 20 SECONDS. THIS WAS DISCOVERED DURING A UCL PROCEDURE ON (B)(6) 2024.

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

  MAUDE report 19606570 ↗
• MalfunctionJun 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 05/23/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEMS REND HANDLE OF THE TAP BECAME DISASSOCIATED FROM THE METAL PORTION. THIS OCCURRED DURING AN ELBOW UCL REPAIR ON (B)(6) 2024, WHERE NO FRAGMENTS WERE LEFT IN THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-7715 UCL INTERNAL BRACE IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 19569892 ↗
• MalfunctionJun 13, 2024Mechanical Jam; Mechanical Jam

  ON 3/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE DRILL AND DRILL GUIDE FROM AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM MELTED TOGETHER WHILE DRILLING. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19533126 ↗
• MalfunctionJun 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM HAD AN ISSUE DURING AN ELBOW UCL PROCEDURE ON (B)(6) 2023 . THE SURGEON DRILLED THE TUNNEL, INSERTED THE FIRST TAP OF GREY COLOR, AND DREW THE TAP TO THE BLACK LASER LINE WHEN THE TAP BECAME STUCK INSIDE THE PATIENT. HE WAS UNABLE TO REMOVE IT BECAUSE THE GREY HANDLE BECAME DISCONNECTED FROM THE METAL SHAFT, NOTHING BROKE OFF INSIDE THE PATIENT. PLIERS WERE USED TO REMOVE THE METAL TAP IN A COUNTERCLOCKWISE FASHION IN ONE PIECE, NOTHING BROKE OFF OR REMAINED INSIDE THE PATIENT. AN ANCHOR WAS INSERTED, AND THE CASE WAS COMPLETED WITHOUT INCIDENT. THE DEVICE WAS DISCARDED, NO PICTURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505346 ↗
• MalfunctionJun 5, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 09/02/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEMS DRILL THREADS GOT CAUGHT IN THE DRILL GUIDE. THIS OCCURRED DURING AN UNKNOWN CASE AND A NEW KIT WAS OPENED TO USE THE DRILL IN THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470781 ↗
• MalfunctionMay 2, 2024Break; Break

  ON 04/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEMS IMPLANT BROKE. THIS OCCURRED DURING A UCL RECONSTRUCTION ON (B)(6) 2024 WHEN THE ANCHOR BODY BROKE UPON INSERTION. THE FRAGMENT WAS RETRIEVED. THE PATIENT HAD A PRETTY GOOD BONE PREPPED USING THE DRILL AND TAP FROM THE KIT. THE CASE WAS COMPLETED USING ANOTHER AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEMS

  Patient problems: Insufficient Information

  MAUDE report 19233800 ↗
• MalfunctionMar 28, 2024Break; Break

  ON 3/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE RED HANDLE OF THE TAP FROM AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM BROKE OFF THE SHAFT AND WOULD NOT SPIN THE SHAFT, ONLY THE RED HANDLE WOULD SPIN. THE SURGEON USED PLIERS TO HELP ROTATE THE TAP AND COMPLETE THE BONE SOCKET. THIS WAS DISCOVERED DURING A UCL ELBOW PROCEDURE ON (B)(6) 2024. NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18992803 ↗
• MalfunctionJan 30, 2023Break; Difficult to Insert

  ON 1/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT ONE OF THE PEEK SWIVELOCK ANCHORS FROM AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM, BROKE DURING INSERTION, THE OTHER IMPLANTED SUCCESSFULLY. SURGEON REMOVED ALL THE BROKEN FRAGMENTS. ANOTHER AR-7715 KIT WAS OPENED, IN WHICH ONE OF THE PEEK SWIVELOCK ANCHORS BROKE AGAIN AND THE OTHER WAS IMPLANTED. ALL BROKEN FRAGMENTS WERE RETRIEVED AND AN AR-2325BCC BIOCOMPOSITE SWIVELOCK WAS OPENED, BUT THIS ONE TOO BROKE DURING INSERTION. CASE WAS COMPLETED BY REMOVING ALL BROKEN FRAGMENTS AND USING THE COMBINATION OF THE PEEK SWIVELOCKS FROM THE KITS AND ADDITIONAL SUTURES. THIS WAS DISCOVERED DURING AN ELBOW UCL REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 16263616 ↗
• MalfunctionJan 30, 2023Break

  ON 1/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT ONE OF THE PEEK SWIVELOCK ANCHORS FROM AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM, BROKE DURING INSERTION, THE OTHER IMPLANTED SUCCESSFULLY. SURGEON REMOVED ALL THE BROKEN FRAGMENTS. ANOTHER AR-7715 KIT WAS OPENED, IN WHICH ONE OF THE PEEK SWIVELOCK ANCHORS BROKE AGAIN AND THE OTHER WAS IMPLANTED. ALL BROKEN FRAGMENTS WERE RETRIEVED AND AN AR-2325BCC BIOCOMPOSITE SWIVELOCK WAS OPENED, BUT THIS ONE BROKE DURING INSERTION. CASE WAS COMPLETED BY REMOVING ALL BROKEN FRAGMENTS AND USING THE COMBINATION OF THE PEEK SWIVELOCKS FROM THE KITS AND ADDITIONAL SUTURES. THIS WAS DISCOVERED DURING AN ELBOW UCL REPAIR PROCEDURE ON (B)(6) 2023.

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

  MAUDE report 16263603 ↗
• MalfunctionNov 21, 2022Break; Material Fragmentation

  ON 11/2/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE DRILL FROM AN AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM, WAS BRUSHING AGAIN THE DRILL GUIDE. THIS CAUSED THE DRILL TO PRODUCE DEBRIS AND TO BREAK. SURGEON REMOVED ALL BROKEN FRAGMENTS FROM INSIDE PATIENT. THIS WAS DISCOVERED DURING A UCL PROCEDURE ON (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 15834938 ↗
• MalfunctionApr 25, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-7715 UCL IMPLANT KIT ANCHOR BROKE PREMATURELY. CASE WAS COMPLETED USING A SEPARATE 3.5 BY 8.5 FORKED TIP SWIVELOCK. THIS WAS DISCOVERED DURING A UCL REPAIR PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14195411 ↗
• InjuryDec 26, 2019Positioning Failure

  IT WAS REPORTED DURING A UCL RECONSTRUCTION PROCEDURE, AFTER THE SURGEON HAD FINISHED THE REPAIR THEY STARTED THE INTERNAL BRACE PORTION OF THE SURGERY. UPON TRYING TO IMPLANT THE ANCHOR WITHIN THE AR-7715 UCL INTERNAL BRACE IMPLANT SYSTEM, THE ANCHOR WOULD NOT SEAT AND CONTINUED TO FALL OFF THE END OF THE INSERTER. NO PIECES OF THE ANCHOR WERE LEFT IN THE PATIENT. THE SURGEON DECIDED NOT TO PERFORM THE INTERNAL BRACE PORTION OF THE CASE, AND THE SURGERY WAS COMPLETED. THE COMPLAINT DEVICE WAS DISCARDED AND WILL NOT BE RETURNING FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9519500 ↗