Arthrex® AR-1787PJ-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867295629), received between Apr 7, 2021 and Aug 20, 2025 — classified as 6 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Break; Material Fragmentation; Break; Material Fragmentation

  ON 8/4/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1787PJ-CP INTERNALBRACE IMPLANT SYSTEM HAD AN ISSUE DURING USE IN AN INTERNAL BRACE PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON WAS USING THE DEVICE, THE THREADED TOP PORTION OF THE CANNULATED 2.7 MM DRILL IN THAT KIT BROKE INSIDE THE PATIENT¿S BONE; IT SHATTERED INTO SEVERAL FRAGMENTS. THE SURGEON WAS ABLE TO REMOVE A FEW OF THE FRAGMENTS, BUT SOME REMAINED INSIDE THE PATIENT'S BONE. THE SURGEON OPENED ANOTHER AR-1787PJ-CP INTERNALBRACE IMPLANT SYSTEM WITH LOT NUMBER 15427045 TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO FURTHER PATIENT HARM. THE SURGEON STATED THAT NO ADDITIONAL PROCEDURE WAS DEEMED NECESSARY. PICTURES AND AN X-RAY WERE TAKEN. THERE WAS A CASE DELAY OF OVER 60 MINUTES, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED. ON 8/5/2025, THE SALES REPRESENTATIVE STATED VIA PHONE THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS DUE TO THE ADDITIONAL ANESTHESIA OR THE DRILL FRAGMENTS BEING LEFT INSIDE THE JOINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22849196 ↗
• MalfunctionSep 12, 2024Break; Break

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1787PJ-CP INTERNALBRACE IMPLANT SYSTEM, LIGAMENT AUGMENTATION REPAIR, HAD AN ISSUE. THE SURGEON DRILLED WITH A 3.4 DRILL AND USED THE TAP TO PREPARE FOR IMPLANT INSERTION. DURING INSERTION, THE PEEK SCREW FROM THE SWIVELOCK BECAME TOO COMPRESSED AND BROKE DURING IMPLANTATION AND WAS NOT ABLE TO GET IMPLANTED AND WAS REMOVED FROM THE PATIENT (PHOTO ATTACHED). THE REP STATED THE SURGEON WAS NOT AUGMENTING WITH A LIGAMENT OR ALLOGRAFT AND WAS USING THE INTERNAL BRACE PORTION FOR THIS PROCEDURE. THE CASE WAS COMPLETED USING ANOTHER AR-1787PJ-CP INTERNALBRACE IMPLANT SYSTEM FROM A DIFFERENT LOT NUMBER. THE CASE WAS DELAYED UNDER 15 MINUTES WITHOUT ADVERSE EFFECTS ON THE PATIENT. IT WAS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THIS WAS DISCOVERED DURING AN ELBOW RADIAL COLLATERAL LIGAMENT REPAIR PROCEDURE ON 08/26/2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20205788 ↗
• MalfunctionSep 6, 2024Break; Break

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1787PJ-CP INTERNAL BRACE KIT 2.7 DRILL BIT BROKE WHEN DRILLING INTO THE TALUS. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED USING A DIFFERENT 2.7 DRILL BIT. ALL FRAGMENTS NOT REMOVED, ONE SHARD WAS FOUND IN X-RAY BUT WILL NOT AFFECT PATIENT. DELAY IN CASE 5 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 20158151 ↗
• MalfunctionJun 7, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON OPENED THE AR-1787PJ-CP MINI INTERNAL BRACE KIT TO DO AN INTERNAL BRACE FOR AN AITFL. THE FIRST ANCHOR (3.5 SL W/ FIBERTAPE) OUT OF THE KIT WAS IMPLANTED AS DESIGNED. WHEN THE SECOND ANCHOR WAS LOADED AND INSERTED THE SCREW WOULD NOT SEAT ALL THE WAY. THE REP REPORTED UPON INSPECTION IT LOOKS LIKE THE METAL SHEATH WAS NOT PRESSED INTO THE BLACK PLASTIC PADDLE FAR ENOUGH RESULTING IN THE EYELET NOT REACHING THE BOTTOM OF THE TUNNEL CAUSING THE ANCHOR TO NOT FULLY SEAT. THE SURGEON OPENED A 4.75 PEEK SWIVELOCK (AR-2324PSLC) TO USE IN PLACE OF THE DAMAGED 3.5 SWIVELOCK AND COMPLETED THE CASE AS SCHEDULED. SEE ATTACHED IMAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483926 ↗
• MalfunctionJan 15, 2024Material Fragmentation; Material Fragmentation

  ON 12/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1787PJ-CP INTERNALBRACE IMPLANT SYSTEM, LIGAMENT AUGMENTATION REPAIR, HAD AN ISSUE WITH THE 2.7MM DRILL. WHEN DRILLING IN THE BONE, THE DRILL BIT SHATTERED AND LEFT SHARDS IN THE BONE. THE SURGEON REMOVED THE FRAGMENTS OF THE DRILL BIT AND PERFORMED AN X-RAY WHEN THE PATIENT WAS OPEN TO CONFIRM THAT ALL THE FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED BY DOING A PRIMARY LIGAMENT REPAIR USING AN AR-899OST FIBERTAK DX SUTURE ANCHOR, AND THE INTERNAL BRACE WAS NOT INCORPORATED INTO THE PROCEDURE. THERE WAS A 15-20 MINUTE DELAY IN THE CASE WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. THIS WAS DISCOVERED DURING AN ATFL RECONSTRUCTION PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510765 ↗
• MalfunctionApr 7, 2021Break

  IT WAS REPORTED THAT DURING AN UCL INTERNAL BRACE USING AR-1787PJ-CP, A MINI IB 2.0 KIT. THE SURGEON FOLLOWED PROPER TECHNIQUE FOR ANCHOR INSERTION AND HAD NO TROUBLE WITH THE FIRST ANCHOR BUT, THE SECOND ANCHOR BROKE WHILE HE TRIED TO INSERT IT. THE BROKEN ANCHOR WAS REMOVED ENTIRELY AND THE CASE WAS COMPLETED USING A 4.75 SWIVELOCK.

  Patient problems: Failure of Implant

  MAUDE report 11631663 ↗