Arthrex® AR-1788J-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00888867318137), received between Oct 5, 2020 and Aug 28, 2026 — classified as 4 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497549 ↗
• MalfunctionMar 3, 2026Break

  ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM HAD A BROKEN ANCHOR DURING USE. THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILIZATION WITH INTERNAL BRACE PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 23-FEB-2025: THIS ISSUE OCCURRED DURING THE INSERTION OF THE 4.75MM SWIVELOCK ANCHOR, WHEN THE THREADED PORTION CRACKED. ALL DETACHED FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT KIT WITH THE SAME ANCHOR TYPE. THE CASE WAS DELAYED FOR LESS THAN ONE MINUTE, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497513 ↗
• InjuryJan 28, 2026Break

  ON 1/3/2024, AN EMAIL WAS RECEIVED FROM A PATIENT REPRESENTATIVE WHO CONFIRMED THE DETAILS OF THE CASE TO AN ARTHREX EMPLOYEE WITH THE FOLLOWING DETAILS. A PATIENT LEGAL REPRESENTATIVE REPORTED VIA EMAIL THAT A PATIENT UNDERWENT LATERAL ANKLE LIGAMENT RECONSTRUCTION OF THE LEFT FOOT PROCEDURE ON (B)(6) 2022 IN WHICH A DRILL BIT BROKE OFF INTO THE TALAR BODY AS WELL AS THE DISTAL PORTION OF THE PIN. MULTIPLE IMAGES WERE TAKEN USING A C-AM, AND THERE WERE NO SIGNS OF THE PIN OR THE DRILL BIT IN THE JOINT OR SURGICAL SITE. AT THE TIME, THE SURGEON DECIDED TRYING TO RETRIEVE THE BROKEN PIECES WOULD CAUSE MORE DAMAGE THAN LEAVING THEM INSIDE THE PATIENT. FOLLOWING THE (B)(6) 2022, SURGERY, THE PATIENT CONTINUED TO REPORT PAIN AND REQUESTED REMOVAL OF THE RETAINED FRAGMENTS. ALTHOUGH THE SURGEON ADVISED REPEATEDLY THAT REMOVAL OF THE RETAINED FRAGMENTS MAY CAUSE MORE DAMAGE AND WAS NOT CONCERNED WITH LEAVING THEM IMPLANTED, THE PATIENT INSISTED ON REMOVAL. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023 FOR REMOVAL OF THE LEFT ANKLE IMPLANTS, THE PIN, AND THE DRILL BIT. USING LIGHT DRILLING AND A RONGEUR, THE TIP OF THE BROKEN DRILL BIT BECAME EVIDENT, AND IT WAS REMOVED. AFTER MUL

  Patient problems: Pain

  MAUDE report 24203382 ↗
• MalfunctionJan 6, 2026Break

  ON 15-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT DURING A PROCEDURE INVOLVING THE AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM, THE TIP OF THE CANNULATED DRILL AND THE TIP OF THE K-WIRE BROKE OFF INSIDE THE BONE WHILE DRILLING. THE SURGICAL TEAM EXPERIENCED DIFFICULTY REMOVING THE BROKEN PIECES. ADDITIONAL INFORMATION WAS REQUESTED ON 19-DEC-2025.

  Patient problems: Insufficient Information

  MAUDE report 23975675 ↗
• MalfunctionJan 5, 2026Break

  ON 16-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT DURING A PROCEDURE INVOLVING THE AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM, THE TIP OF THE CANNULATED DRILL BROKE, RESULTING IN FRAGMENTS OF THE DRILL BIT EMBEDDED IN THE PATIENT'S BONE. THE SURGEON WAS ABLE TO EXTRACT THE BROKEN PIECES AND CONTINUED THE PROCEDURE WITHOUT COMPLICATION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 23-DEC-2025: THIS OCCURRED DURING A SPRING LIGAMENT PROCEDURE DURING THE DRILLING STAGE BEFORE IMPLANT INSERTION. THE BONE QUALITY WAS ASSESSED AS HARD. THE CASE WAS COMPLETED USING A REPLACEMENT AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM. THE CASE WAS DELAYED TWO MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959808 ↗
• InjuryDec 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, IT WAS REPORTED BY THE PATIENT VIA EMAIL TO HAVE UNDERGONE AN ATFL SURGERY ON (B)(6) 2022. ON (B)(6) 2025, A REPEAT MRI WAS CONDUCTED DUE TO SEVERE ANKLE PAIN, AND PER THE PATIENT, THE RESULTS INDICATED HARDWARE FAILURE. THE IMPLANTED DEVICE WAS AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM. LATER, THE PATIENT REPORTED VIA PHONE THAT A HARDWARE FAILURE OCCURRED APPROXIMATELY THREE YEARS POST-IMPLANT. RECONSTRUCTION SURGERY IS EXPECTED, WITH AN ANTICIPATED RECOVERY PERIOD EXCEEDING 12 WEEKS. ACCORDING TO THE PATIENT, THE SURGEON CONFIRMED THE NEED FOR RECONSTRUCTION. ADDITIONAL INFORMATION WAS RECEIVED ON 25-NOV-2025: THE PATIENT HAS A HISTORY OF LEFT CLUBFOOT CORRECTION DURING INFANCY AND UNDERWENT A STABILIZATION PROCEDURE IN 2022. THE PATIENT EXPERIENCED A LOUD POP IN THE LEFT ANKLE ON (B)(6) 2025, FOLLOWED BY PAIN, SWELLING, AND LIMITED MOBILITY. OFFICE VISIT ON (B)(6) 2025 AND MRI ON (B)(6) 2025 REVEALED HARDWARE FAILURE, TALUS STRESS FRACTURE, AND POSTSURGICAL CHANGES WITH SIGNIFICANT ARTIFACTS. CONSERVATIVE TREATMENT BEGAN (B)(6) 2025, INCLUDING IMMOBILIZATION IN A CAM BOOT, BUT THE PATIENT REPORTED NO IMPROVEMENT. A FOLLOW-UP ON (B)(6) 2025 CONFIRMED HARDWARE FAIL

  Patient problems: Bone Fracture(s); Neuralgia; Pain; Swelling/ Edema

  MAUDE report 23882135 ↗
• MalfunctionNov 25, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ON 10/29/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT A PATIENT WAS SCHEDULED FOR A RIGHT ANKLE LATERAL LIGAMENT REPAIR. DURING THE PROCEDURE, THE TEAM UTILIZED AN INTERNALBRACE IMPLANT SYSTEM AR-1788J-CP. ONE OF THE GUIDEWIRES BROKE OFF IN THE PATIENT'S TALUS BONE DUE TO THE BONE BEING EXTREMELY HARD. ATTEMPTS TO REMOVE THE GUIDEWIRE WERE UNSUCCESSFUL. IT WAS NOTED THAT FURTHER EFFORTS TO RETRIEVE THE WIRE COULD HAVE CREATED A DEFICIT IN THE BONE, POTENTIALLY PREVENTING COMPLETION OF THE PROCEDURE. THE GUIDEWIRE WAS LEFT IN PLACE, WITH NO PORTION PROTRUDING THAT COULD CAUSE FURTHER INJURY. THIS WAS DISCOVERED DURING A LIGAMENT REPAIR PROCEDURE IN (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/05/2026: ON (B)(6) 2025, A RIGHT ANKLE LATERAL LIGAMENT REPAIR WAS PERFORMED. THE SURGEON ELECTED TO LEAVE THE PIN IN PLACE AND REDIRECTED THE DRILL HOLE SLIGHTLY MORE PROXIMALLY AND POSTERIORLY. DRILLING WAS CONDUCTED UNDER C-ARM GUIDANCE TO CONFIRM THERE WAS NO INTRA-ARTICULAR PENETRATION. THE DRILL HOLE WAS THEN TAPPED, AND A SWIVELOCK ANCHOR WITH INTERNAL BRACE WAS PLACED, ACHIEVING EXCELLENT FIXATION. THE PROCEDURE WAS DELAYED

  Patient problems: Foreign Body In Patient

  MAUDE report 23646952 ↗
• MalfunctionJul 25, 2025Break; Break

  ON 07/03/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1788J-CP INTERNALBRACE¿ IMPLANT SYSTEMS DRILL BIT SHATTERED. THIS OCCURRED DURING AN INTERNAL BRACE BROSTRUM PROCEDURE ON (B)(6) 2025, WHERE ALL FRAGMENTS WERE ABLE TO BE RETRIEVED. THE PATIENT HAD FINE BONE QUALITY. THERE WAS NO DELAY IN THE PROCEDURE, AND A SOLID DRILL WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609213 ↗
• MalfunctionJul 23, 2025Break; Break

  ON 07/01/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE EYELET OF THE 3.5 SWIVELOCK IN THE AR-1788J-CP INTERNAL BRACE IMPLANT SYSTEM BROKE DURING INSERTION. THEY DRILLED WITH THE HARD BONE DRILL AND USED THE CORRECT TAP TO PREP THE IMPLANT. THEY HAD TO OPEN ANOTHER KIT TO REPLACE THE BROKEN SWIVELOCK TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 07/10/2025. ADDITIONAL INFORMATION WAS RECEIVED ON 7/15/2025: A LATERAL ANKLE PROCEDURE WITH INTERNAL BRACE AND BROSTROM REPAIR WAS BEING PERFORMED. THE SURGERY WAS COMPLETED USING ANOTHER AR-1788J-CP INTERNAL BRACE IMPLANT SYSTEM. THE PROCEDURE EXPERIENCED A BRIEF DELAY OF A FEW MINUTES WHILE A NEW KIT WAS OBTAINED. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE EYELET EXPERIENCED BREAKAGE DURING THE EVENT; HOWEVER, ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED, AND NO ADVERSE EFFECTS OR SIGNIFICANT DAMAGE WERE REPORTED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584072 ↗
• MalfunctionJul 15, 2025Break; Break

  ON 06/18/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL AN ISSUE INVOLVING THE AR-1788J-CP INTERNAL BRACE IMPLANT SYSTEM. THE 2.7 MM DRILL BIT ENCOUNTERED A PROBLEM WHILE A K-WIRE WAS UTILIZED IN THE TALUS. WHILE DRILLING, THE TIP OF THE DRILL BIT AND THE END OF THE K-WIRE BROKE WITHIN THE PATIENT¿S BONE. THEY WERE ABLE TO RETRIEVE THE REMAINS, AND EVERYTHING WAS REMOVED FROM THE SURGERY SITE. THE 4.75 MM SWIVELOCK AND 3.5 MM SWIVELOCK ANCHORS REMAINED IMPLANTED IN THE PATIENT. THIS WAS DISCOVERED DURING A DELTOID INTERNAL BRACE PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507903 ↗
• MalfunctionMay 9, 2025Break; Break

  ON 4/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3.4 CANNULATED DRILL FROM AN AR-1788J-CP BIOCOMPOSITE INTERNALBRACE IMPLANT SYSTEM BROKE AT THE TIP INTO THE TALUS. IT WAS REMOVED FROM THE BONE WITH A DENTAL PICK, AND THE CASE WAS COMPLETED WITH A NEW AR-1788J-CP BIOCOMPOSITE INTERNALBRACE IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED ON 5/8/2025.

  Patient problems: Insufficient Information

  MAUDE report 21995566 ↗
• MalfunctionApr 22, 2025Break; Break

  ON 3/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE 3.4 CANNULATED DRILL BIT FROM AN AR-1788J-CP BIOCOMPOSITE INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM BROKE IN THE PATIENT'S TALUS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 4/21/2025.

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

  MAUDE report 21884151 ↗
• MalfunctionFeb 24, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM 2.7 DRILL BIT BROKE INTO MULTIPLE PIECES WHILE DRILLING IN THE SUSTENTACULUM TALI OF THE CALC OVER TOP OF THE 1.1MM K-WIRE THAT CAME IN THE IB KIT. THE BONE WAS NOT ABNORMALLY HARD, AND THE SURGEON WAS DRILLING IN LINE WITH THE K-WIRE. THERE WERE NO OTHER IMPLANTS THEY WERE HITTING. THEY RETRIEVED AS MANY PIECES OF THE DRILL BIT AS POSSIBLE, USED ANOTHER 1.1MM K-WIRE TO DRIVE IN ANOTHER SPOT IN THE CALC, AND USED THE 3.4 MM DRILL BIT, WHICH THEN BROKE THE K-WIRE OFF IN THE BONE. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A SPRING LIGAMENT INTERNAL BRACE PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 02/11/2025: THE K-WIRE THAT BROKE IN THE BONE WAS NOT RETRIEVED FROM THE PATIENT AND WAS BURIED IN THE BONE; THEREFORE, THE SURGEON WAS FINE LEAVING IT IMPLANTED. THERE IS NO REVISION SURGERY NEEDED. THE CASE WAS COMPLETED USING THE SPRING LIGAMENT IB TECHNIQUE USING THE AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM. THE ONLY DIFFERENCE WAS THEY USED A 3.4 DRILL FOR THE 3.5 ANCHOR BECAUSE THE 2.7 CRUMBLED. IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS

  Patient problems: Foreign Body In Patient

  MAUDE report 21444614 ↗
• MalfunctionJan 10, 2025Break; Break

  ON (B)(6) 2024 IT WAS REPORTED, BY A SALES REPRESENTATIVE VIA PHONE, THAT THE DRILL BIT FROM AN AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM BROKE. ALL THE BROKEN FRAGMENTS WERE REMOVED. THIS WAS DISCOVERED DURING AN ATFL BROSTROM PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING ANOTHER AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM. THE CASE WAS DELAYED LESS THAN FIFTEEN MINUTES.

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

  MAUDE report 21123029 ↗
• MalfunctionAug 14, 2024Break; Break

  ON 07/31/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8978-CP DRILL BIT BROKE OFF IN THE BONE, THE FRAGMENT WAS UNABLE TO BE REMOVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY IN CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19987700 ↗
• MalfunctionJun 14, 2024Material Separation; Material Separation

  ON 3/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE KNOB OF A BIOCOMPOSITE SWIVELOCK FROM AN AR-1788J-CP INTERNALBRACE, LIGAMENT AUGMENTATION REPAIR, BIOCOMPOSITE, WITH JUMPSTART DRESSING IMPLANT SYSTEM, WOULD NOT TURN, WHICH RESULTED IN THE THREADS ON THE SHAFT OF THE SWIVELOCK SEPARATING FROM THE KNOB. THE CASE WAS COMPLETED USING ANOTHER AR-1788J-CP IMPLANT SYSTEM. ADDITIONAL INFORMATION RECEIVED ON 4/3/2023: THIS WAS DISCOVERED DURING A BROSTRORM REPAIR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19541548 ↗
• MalfunctionMay 27, 2024Crack; Crack

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHILE THE SURGEON WAS USING THE 3.5 SL FROM THE IB 2.0 KIT CRACKED BEFORE INSERTION CAUSING THE INSERTER TO PUSH THROUGH THE ANCHOR AND CAUSING IT TO PULL OUT. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED WITH A NEW AR-1788J-CP.

  Patient problems: Insufficient Information

  MAUDE report 19400868 ↗
• MalfunctionMay 26, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE 3.5 SWIVELOCK BROKE. THE PRODUCT WAS DISCARDED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398859 ↗
• MalfunctionMay 16, 2024Break; Break

  ON 4/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM HAD THE DRILL BIT DIGGING INTO THE GUIDEWIRE WHEN OVER-DRILLING, RESULTING IN THE GUIDEWIRE AND 3.4 CANNULATED DRILL BREAKING IN THE TALUS. THE METAL FRAGMENT WAS NOT RETRIEVED FROM THE TALUS. THE REP VERIFIED THE ANGLE WAS CLOSE WHEN DRILLING. THE CASE WAS COMPLETED USING ANOTHER AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM WITH NO REPORTED DELAY IN THE PROCEDURE AND NO ADVERSE EFFECTS REPORTED. A PHOTO ATTACHMENT FOR THIS CASE WAS PROVIDED SHOWING THE CHIPPED/BENT GUIDEWIRE. THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILIZATION PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 19329848 ↗
• MalfunctionMay 16, 2024Break; Break

  ON 4/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM HAD THE DRILL BIT DIGGING INTO THE GUIDEWIRE WHEN OVER-DRILLING, RESULTING IN THE GUIDEWIRE AND 3.4 CANNULATED DRILL BREAKING IN THE TALUS. THE METAL FRAGMENT WAS NOT RETRIEVED FROM THE TALUS. THE REP VERIFIED THE ANGLE WAS CLOSE WHEN DRILLING. THE CASE WAS COMPLETED USING ANOTHER AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM WITH NO REPORTED DELAY IN THE PROCEDURE AND NO ADVERSE EFFECTS REPORTED. THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILIZATION PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 19329414 ↗
• MalfunctionMay 16, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM HAD THE DRILL BIT DIGGING INTO THE GUIDEWIRE WHEN OVER-DRILLING, RESULTING IN THE GUIDEWIRE AND 3.4 CANNULATED DRILL BREAKING IN THE TALUS. THE METAL FRAGMENT WAS NOT RETRIEVED FROM THE TALUS. THE REP VERIFIED THE ANGLE WAS CLOSE WHEN DRILLING. THE CASE WAS COMPLETED USING ANOTHER AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM WITH NO REPORTED DELAY IN THE PROCEDURE AND NO ADVERSE EFFECTS REPORTED. THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILIZATION PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024: THIS PROCEDURE OCCURRED ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 19329349 ↗
• MalfunctionMay 7, 2024Break; Break

  ON 4/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT EITHER AN AR-8991 FIBERTAK DX SUTURE ANCHOR OR AN AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM HAD AN ISSUE. DURING A BROSTROM PROCEDURE ON (B)(6) 2023, THE GUIDEWIRE BROKE INSIDE THE PATIENT AND COULD NOT BE REMOVED FROM THE PATIENT. THE SALES REPRESENTATIVE WHO HAD ATTENDED THE CASE IN 2023 NO LONGER WORKED FOR THE AGENCY AND HAD PREVIOUSLY NOT REPORTED THE CASE. THE SURGEON HAD NOW CONTACTED THE SALES REPRESENTATIVE VIA PHONE TO REPORT THE CASE AND INFORM HIM THAT THE PATIENT WAS SUING THE SURGEON. THE SURGEON DID NOT CONFIRM WHICH OF THE TWO DEVICES BROKE, HOW THE CASE WAS COMPLETED, IF THE CASE WAS COMPLETED SUCCESSFULLY, IF THERE WAS A CASE DELAY, IF ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT. THIS OCCURRED DURING USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT THE SALES REPRESENTATIVE ASKED TO CONTACT THE SURGEON DIRECTLY VIA PHONE FOR FURTHER INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19259524 ↗
• MalfunctionApr 8, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT BOTH CANNULATE DRILL BITS FROM AN AR-1788J-CP BIOCOMPOSITE INTERNALBRACE IMPLANT SYSTEM, LIGAMENT AUGMENTATION REPAIR, WITH JUMP START DRESSING BROKE INTO THE PATIENT'S TALUS. THE SUTURE PASSING WIRE ALSO BROKE IN THE PATIENT BUT WAS RETRIEVED FROM THE PATIENT. THE BROKEN DRILL BITS REMAIN IN THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 19067363 ↗
• MalfunctionMar 13, 2024Break; Break

  ON 2/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM HAD AN ISSUE DURING AN ATS LATERAL LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2024. THE SURGEON WAS USING THE 3.4 CANNULATED DRILL BIT, AND AFTER DRILLING ONE CYCLE, THE K-WIRE AND THE ANKLE STARTED SHAKING A BIT. THE 3.4 CANNULATED DRILL BIT WAS REMOVED, AND BEFORE DRILLING AGAIN IN THE TIBIA, THE SURGEON NOTICE THAT THE TIP OF THE DEVICE WAS BROKEN. X-RAYS HAD BEEN TAKEN BEFORE AND AND AGAIN AFTERWARDS, AND NO METAL PIECE WAS FOUND IN THE TALUS BONE OR INSIDE THE PATIENT. THEY WERE TRYING TO LOCATE A METAL PIECE ON THE FLOOR, BUT IT COULD NOT BE FOUND EITHER, SO IT WAS ASSUMED THAT IT MIGHT HAVE BEEN DAMAGED OUT-OF-BOX, BUT HAD INITIALLY NOT BEEN NOTICED. ANOTHER 3.4 SOLID DRILL BIT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY, AND THERE WAS NO HARM TO THE PATIENT. A CASE DELAY OF 20 MINUTES WAS REPORTED, AND THERE WAS NO ADDITIONAL ANESTHESIA ADMINISTERED TO THE PATIENT. THIS OCCURRED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896466 ↗
• MalfunctionMar 11, 2024Break; Break

  ON (B)(6) 2024, A MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE GUIDEWIRE TIP FROM AN AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM BROKE IN THE PATIENT'S BONE. AN ANCHOR WAS PLACED IN THE LEFT ANKLE, AND THE GUIDEWIRE BROKE PROXIMAL TO THE ANCHOR. THE TIP WAS NOT RETRIEVED. THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILIZATION PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 18877512 ↗