Arthrex® AR-1530P-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867242081), received between Jan 29, 2018 and Jun 7, 2024 — classified as 9 injuries, 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  2/13/2023, IT WAS REPORTED BY SALES REPRESENTATIVE VIA EMAIL THAT THE ANCHOR OF ONE OF THE TENODESIS SCREWDRIVER FROM AN AR-1530P-CP FOREFOOT INTERNALBRACE IMPLANT SYSTEM, WOULD NOT COME OFF THE INSERTER HANDLE. THIS WAS DISCOVERED DURING A PLANTAR PLATE INTERNALBRACE PROCEDURE ON (B)(6) 2023. CASE WAS COMPLETED USING ANOTHER AR-1530P-CP KIT. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492935 ↗
• MalfunctionJun 2, 2024Connection Problem; Connection Problem

  ON 10/07/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHEN THE SURGEON WAS TRYING TO PLACE THE 3MM X 8MM TENODESIS SCREW FROM KIT AR-1530P-CP, INTO THE DORSAL SIDE OF THE METATARSAL AND PHALANX OF THE PATIENT, THE SCREWS WOULD NOT RELEASE FROM THE DRIVER. THE SURGEON TRIED TO PULL THE SCREW OFF OF THE DRIVER AND PLACING IT GENTLY BACK ON PRIOR TO INSERTING IT, BUT WAS UNABLE. THIS WAS DISCOVERED DURING USE IN A FOREFOOT IB PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING 2 SWIVELOCKS INSTEAD OF THE TENODESIS SCREWS FROM THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444684 ↗
• MalfunctionJun 20, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1530P-CP FOREFOOT IB IMPLANT SYSTEM HAD AN ISSUE, THE ANCHOR SNAPPED INSIDE THE DRIVER DURING INSERTION. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2022, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED ON (B)(6) 2022 DURING A PLANTAR PLATE IB PROCEDURE. A DRILL FROM THE KIT WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION OF THE IMPLANT, BUT THE BONE QUALITY WAS NOT PROVIDED. A PIECE OF THE INSTRUMENT BROKE INSIDE THE PATIENT, ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED, THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744917 ↗
• MalfunctionJun 1, 2021Break

  IT WAS REPORTED DURING A PLANTAR PLATE PROCEDURE, THE TIP OF THE TENODESIS DRIVER BROKE INSIDE THE 3X8 TENODESIS SCREW AND COULD NOT BE REMOVED. THE REP REPORTED THE CASE WAS ABLE TO BE COMPLETED WITH THE PIECE STILL IN THE SCREW.

  Patient problems: Insufficient Information

  MAUDE report 11911988 ↗
• InjurySep 21, 2020Break

  IT WAS REPORTED THAT THE SURGEON NOTED A FOREIGN BODY ON FLUOROSCOPY AT THE END OF THE PROCEDURE. IT WAS DETERMINED THAT THIS WAS THE TIP OF THE INSERTION DEVICE FOR THE ARTHREX INTERNAL BRACE PEEK IMPLANT THAT HAD BROKEN OFF. UPDATE 9/11/2020: ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FACILITY REPORTER BUT TO DATE HAS NOT BEEN RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10562667 ↗
• InjuryJun 23, 2020Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A FIRST MTP INTERPOSITIONAL ARTHROPLASTY WITH ARTHROFLEX PROCEDURE, THE SCREWDRIVER BROKE WHILE IMPLANTING THE PEEK SCREW INTO THE MET HEAD. THE SCREW WAS COMPLETELY ADVANCED AND WHEN THE SURGEON ATTEMPTED TO PULL THE DRIVER OUT, THE METAL SHAFT SNAPPED. THE METAL SHAFT WAS LEFT IN THE PATIENT AS THE SCREW WAS FLUSH AND IT WOULD HAVE DONE MORE DAMAGE TRYING TO GET IT OUT. ATTEMPT WAS MADE TO RETRIEVE IT WITH A PICKUP BUT WAS UNSUCCESSFUL. IT IS BURIED WITHIN THE PEEK SCREW AND IS ONLY VISIBLE ON X-RAY. A PICTURE OF THE BROKEN SCREW DRIVER HAS BEEN PROVIDED TO ARTHREX. ADDITIONAL INFORMATION PROVIDED 5/26/2020: THE DEVICE IS PART OF A FOREFOOT INTERNAL BRACE KIT (PART NUMBER NOT PROVIDED). THE ENTIRE SHAFT AT THE END OF THE SCREWDRIVER WAS LEFT IN THE SCREW INSIDE THE PATIENT. BONE HAD BEEN PREPPED WITH A 2.5 DRILL BIT PER THE GUIDELINES OF THE ARTHREX TECHNIQUE GUIDE. REMAINING PORTION OF THE SCREWDRIVER WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION PROVIDED 6/1/2020: THE FOLLOWING IS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED: AR-1530-CP, LOT 10499699.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10183985 ↗
• InjuryFeb 25, 2020Break; Difficult to Remove

  IT WAS REPORTED DURING A 2ND MET TRANSVERSE PLANE REPAIR PROCEDURE THE AR-1530P-CP FOREFOOT IB IMPLANT SYSTEM WAS BEING USED. AFTER INSERTING THE 3X8MM TENODESIS SCREW INTO THE PATIENT'S METATARSAL, THE INSERTER FROM THE DRIVER HANDLE BROKE OFF AND WAS STUCK INSIDE THE SCREW CANNULATION, WHICH WAS IN THE PATIENT. INSTRUMENTS WERE USED TO ATTEMPT TO RETRIEVE THE SCREW, BUT DID NOT WORK. THE REP REPORTED FURTHER ATTEMPTS WOULD COMPROMISE THE REPAIR AND PATIENTS METATARSAL, SO THE PIECE WAS LEFT IN THE PATIENT. THE ACCOUNT HAS THE BROKEN DRIVER IN THEIR POSSESSION. ADDITIONAL INFORMATION RECEIVED ON 02/06/2020: THE REP REPORTED THE SURGERY WAS A PRIMARY PROCEDURE. THE BONE QUALITY WAS MEDIUM. NO UNPLANNED INCISIONS WERE NECESSARY AS THERE WAS ADEQUATE EXPOSURE IN THE AREA WHERE THE ISSUE OCCURRED. X-RAYS WERE TAKEN AND CONFIRMED THE BROKEN PIECE REMAINED IN THE SCREW CANNULATION. THE REP STATED THEY WOULD NEED TO OBTAIN APPROVAL FROM THE FACILITY IN ORDER TO SEND DE-IDENTIFIED COPIES OF THE X-RAYS. THE FACILITY TOOK THE TWO DRIVERS FROM THE KIT AND CONFISCATED FOR THEIR OWN REPORTING. THE REP PROVIDED A PICTURE OF THE TWO DRIVERS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9750612 ↗
• InjuryJan 27, 2020Break; Noise, Audible

  IT WAS REPORTED THAT A FOREFOOT IB IMPLANT SYSTEM, AR-1530P-CP, WAS BEING USED IN A FOREFOOT IB FOR HALLUX VARUS. AFTER PASSING THE FIBERTAPE SUTURE THROUGH BOTH BONE TUNNELS, SURGEON WAS FIXATING THE PROXIMAL PHALANX WITH THE 1ST OF TWO PROVIDED 3 X 8 TENODESIS SCREWS. WITH THE LAST COUPLE TURN(S) OF THE SCREW, THERE WAS AN AUDIBLE CLICKING SOUND AND THE DRIVER SHAFT OF THE 3 X 8 TENODESIS SCREW HAD BROKEN OFF FLUSH INSIDE THE SCREW BODY. THE SURGEON ATTEMPTED TO REMOVE THE PIECE, BUT IT WAS DETERMINED THAT THE ONLY WAY TO DO SO WOULD CAUSE MORE HARM TO THE PATIENT AND A LOSS OF FIXATION. THE 3 X 8 SCREW WAS USED AS INDICATED. IT IS BELIEVED BY THE REP THAT THE PATIENT HAD VERY GOOD BONE QUALITY AND THE DRIVER SIMPLY HAD A LITTLE TOO MUCH TORQUE AND SNAPPED OFF ON THE LAST CLOCKWISE TURN. X-WAY CONFIRMED THAT THE DRIVER SHAFT WAS FLUSH WITHIN THE PEEK SCREW WITHIN THE BONE AND NO HARM IS ANTICIPATED TO THE PATIENT. ADDITIONAL INFORMATION PROVIDED 01/07/2020: THERE WERE NO OTHER FRAGMENTS OTHER THAN THE TIP THAT STAYED LODGED WITHIN THE IMPLANT. THE X-RAYS MENTIONED PREVIOUSLY WILL NOT BE RELEASED BY THE FACILITY. THE DRIVER WILL BE RETURNED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9631329 ↗
• InjuryJan 13, 2020Break

  IT WAS REPORTED DURING A PROCEDURE THE SURGEON WAS USING THE AR-1530P-CP FOREFOOT IB IMPLANT SYSTEM AND INSERTED THE 3X8 TENODESIS SCREW IN THE FIRST METATARSAL WITH A 1.3 TIGERLINK. AS THE SURGEON WAS TRYING TO REMOVE THE DRIVER FROM THE 3X8MM TENODESIS SCREW, THE TIP OF THE DRIVER SNAPPED OFF AND STAYED IN THE TENODESIS SCREW. THE SURGEON DID NOT REMOVE THE TIP OF THE DRIVER THAT SNAPPED OFF FROM THE TENODESIS SCREW. AFTER OBSERVING, THE SURGEON DECIDED THAT THEY DID NOT WANT TO REMOVE THE BROKEN DRIVER TIP. THE BONE WAS PREPPED BY USING THE GUIDE WIRE, AND CANNULATED DRILL INCLUDED IN THE AR-1530P-CP. THE GUIDE WIRE WAS PLACED BI-CORTICAL AND THE CANNULATED DRILL WAS ALSO DRILLED BI-CORTICAL. THE BONE QUALITY WAS VERY HARD. ADDITIONAL INFORMATION RECEIVED ON 12/23/2019: THE REP REPORTED THE REMAINING DRIVER IS AVAILABLE TO RETURN FOR EVALUATION. THE REP STATED TO THEIR KNOWLEDGE THE SURGEON VERIFIED THAT THE BROKEN DRIVER TIP WAS NOT SITTING PROUD OF THE SCREW, AND MADE THE DECISION TO LEAVE IT IN THE IMPLANTED TENODESIS SCREW. THE REP DOES NOT HAVE ACCESS TO ANY X-RAY COPIES. THE PROCEDURE BEING PERFORMED WAS AN HALLUX RIGIDUS ARTHROPLASTY WITH ARTHROFLEX DERMAL ALLOGRAFT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9582808 ↗
• InjuryOct 11, 2019Break; Detachment of Device or Device Component

  IT WAS DISCOVERED DURING MONTHLY MAUDE REVIEW THAT THE FOLLOWING INCIDENT HAD BEEN REPORTED: "WHEN USING THE FOREFOOT INTERNAL BRACE IMPLANT SYSTEM, A PIECE OF ONE OF THE INSTRUMENTS BROKE OFF IN THE PATIENT'S FOOT. X-RAY OF THE FOOT WAS DONE, THE PIECE WAS UNABLE TO BE SEEN IN THE FOOT." THE MAUDE REPORT DOES NOT CONFIRM THAT THE DEVICE PIECE WAS LOCATED AND ACCOUNTED FOR. THE MAUDE REPORT DOES NOT CONTAIN ANY REPORTER/FACILITY NAME AND/OR CONTACT INFORMATION. THEREFORE NO FOLLOW UP IS POSSIBLE AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9178762 ↗
• InjuryAug 26, 2019Break; Entrapment of Device

  IT WAS REPORTED BY THE SALES REP, THAT DURING A RIGHT FOOT, PLANTER PLATE FIXATION PROCEDURE, THE SURGICAL RESIDENT PREPPED THE SURGICAL SITE USING A 2.5 DRILL AND AR-7521, (SUTURE TAPE) THE RESIDENT WAS USING THE AR-1530P-CP, (LOT #10298681) FOREFOOT IB IMPLANT SYSTEM TO IMPLANT THE 3 X 8 PEEK TENODESIS SCREW. THE SCREW WAS SEATED PROPERLY. UPON REMOVAL OF THE DRIVER IT WAS NOTICED THAT THE TIP OF THE DRIVER HAD BROKEN OFF AND WAS LEFT IN THE SCREW. THE SURGEON TRIED TO REMOVE THE DRIVER TIP USING K-WIRE AND A DRILL HOWEVER, THE SURGEON WAS NOT SUCCESSFUL IN RETRIEVING THE DRIVER TIP FROM THE SCREW LEAVING THE TIP INSIDE THE PATIENT. THE SURGEON WAS SATISFIED THAT THE 3 X 8 PEEK TENDONSIS SCREW WAS SECURE. THE SURGICAL RESIDENT COMPLETED THE PROCEDURE WITH NO ADDITIONAL ISSUES. THE REP STATED THERE WERE PICTURES CONFIRMING THE DRIVER TIP WAS IN THE SCREW.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8932510 ↗
• InjuryApr 5, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING A FOREFOOT INTERNAL BRACE PROCEDURE, THE SURGEON IMPLANTED THE 3.8 PEEK ANCHOR THAT IS INCLUDED IN THE FOREFOOT IB IMPLANT SYSTEM. THE PATIENT BEGAN TO EXPERIENCE ALLERGIC REACTION-LIKE SYMPTOMS AND IS CURRENTLY SEEING AN ALLERGIST. THE SURGEON BELIEVES THIS MAY BE CAUSED BY THE PEEK IMPLANT. NO FURTHER DETAILS GIVEN AT THIS TIME.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7398735 ↗
• InjuryJan 29, 2018Device Operates Differently Than Expected; Unintended Movement

  IT WAS REPORTED THAT AFTER A DISTAL EXTREMITIES HALLUX VARUS TOE PROCEDURE ON (B)(6) 2017, THE IMPLANT PULLED OUT POST-OP. THE REVISION SURGERY WAS ON (B)(6) 2017 TO REMOVE THE IMPLANT AND IMPLANTED ANOTHER AR-1530P-CP FROM THE SAME LOT. CURRENTLY THE PATIENT IS FINE TO DATE. FOLLOW-UP INVESTIGATION: SURGEON CONFIRMED TO SALES REP THAT THERE WAS NO REPORTED PATIENT INJURY OR TRAUMA POST OP AND PATIENT WAS VERY COMPLIANT. PER SURGEON POST OP FOLLOW UP VISIT AT SURGEON OFFICE SHOWED SIGN OF IMPLANT FAILURE (ANCHOR PULLED OUT). THE AR-1530P-CP WAS COLLECTED AND IS BEING RETURNED FOR EVALUATION. PATIENT WAS A FEMALE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7224272 ↗