Arthrex® AR-1530PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867018662), received between Dec 19, 2016 and Jul 31, 2025 — classified as 10 injuries, 5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ULNAR COLLATERAL LIGAMENT RUPTURE SURGERY THE SCREW WAS STUCK ON THE HANDPIECE. 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 22676470 ↗
• MalfunctionApr 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TENDON FIXATION IN THE HAND THE SCREW DID NOT COME OFF THE SCREWDRIVER. 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 21867249 ↗
• MalfunctionJun 17, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THUMB SURGERY THE SCREW DIDN´T GO OFF THE INSERTER. NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. 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 19547204 ↗
• MalfunctionNov 30, 2021Break

  ON 11/9/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1530PS TENODESIS PEEK SCREW AFTER BEING IMPLANTED AND HAD GREAT FIXATION, COULD NOT BE RELEASED FROM THE INSERTER. SURGEON HAD TO FORCIBLY PULL BACK ON THE INSERTER TO RELEASE IT FROM THE SCREW BUT IT ONLY CAUSE THE PEEK SCREW TO COME OUT OF THE BONE TUNNEL. SURGEON CLAMPED THE SCREW WITH A HEMOSTAT AND BY PULLING, WAS THE ONLY WAY TO GET THE SCREW OFF THE INSERTER. THEN, THE SURGEON TRIED TO IMPLANT THE PEEK SCREW IN THE SAME BONE TUNNEL BUT IT WAS STRIPPED AND HAD TO COMPLETE CASE WITH A DIFFERENT TECHNIQUE. THIS WAS DISCOVERED DURING A PROCEDURE OF A FLEXOR TENDON TRANSFER ON A 2ND METATARSAL ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED 11/9/2021: SALES REPRESENTATIVE HAS CONFIRMED THAT AFTER DEVICE FAILED, SURGEON COMPLETED CASE BY SPLITTING THE FLEX TENDON IN HALF, WRAPPING AROUND BASE OF 2ND METATARSAL, AND SUTURE TOGETHER FOR FIXATION USING THE SAME DEVICE AR-1530PS FROM A DIFFERENT LOT NUMBER. USING THIS TECHNIQUE, IT WAS NOT REQUIRED TO DRILL ANOTHER BONE TUNNEL. THE FAIL DEVICE AND IMPLANT DID NOT BREAK AND THERE WERE NOT BROKEN FRAGMENTS INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896222 ↗
• MalfunctionDec 21, 2020Separation Failure

  IT WAS REPORTED THAT DURING A THUMB UCL RECONSTRUCTION THE SCREW COULD NOT BE DETACHED FROM THE HANDLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER. THE SURGEON HAS SWITCHED TO A DIFFERENT TECHNIQUE TO FINISH THE PROCEDURE. UPDATE 14-DEC-2020: FURTHER INFORMATION WAS PROVIDED THAT NO ADDITIONAL INCISION WAS NECESSARY DUE TO THE TECHNIQUE CHANGE.

  Patient problems: Insufficient Information

  MAUDE report 11046757 ↗
• InjurySep 17, 2020Break; Difficult to Remove

  AN ARTHREX EMPLOYEE HAS REPORTED THAT DURING A HALLUX VARUS SURGERY THE TIP OF THE INSERTER BROKE OFF IN THE SCREW HEAD. THE SURGEON WAS NOT ABLE TO RETRIEVE THE SCREW AND THE TIP OF THE INSERTER OUT OF THE PATIENT. THE SURGEON HAD TO USE AN ADDITIONAL SWIVELOCK TO FINISH THE SURGERY SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10546704 ↗
• InjuryJul 28, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO ONE OF THE DEVICES IMPLANTED IN A CASE ON HER RIGHT WRIST IN (B)(6) 2019 WHICH WAS DUE TO AN INJURY ROLLER SKATING ABOUT TWO YEARS AGO. USED DURING THE CASE WAS AR-1530PS, AR-8978-CP AND A K-WIRE, LOT # 0919343245 (NON-ARTHREX DEVICE). TWO WEEKS AFTER THE CASE, THE PATIENT RETURNED TO THE SURGEON WITH SWOLLEN FINGERS AND A BURNING SENSATION AT THE SITE. SHE IS ALLERGIC TO NICKEL; THE SURGEON WAS AWARE OF THIS PRIOR TO THE CASE BUT HAD THOUGHT THE K-WIRE WAS TITANIUM. WHEN SHE RETURNED. HE RECHECKED THE DEVICES USED AND FOUND THAT THE K-WIRE DID CONTAIN NICKEL; IT WAS THEN REMOVED FROM THE PATIENT. IT WAS ORIGINALLY SUPPOSED TO BE IN FOR EIGHT WEEKS TO IMMOBILIZE THE SITE AND WOULD HAVE BEEN REMOVED AFTER THAT. AFTER IT WAS REMOVED, THE PATIENT'S SYMPTOMS WERE REDUCED, BUT SHE STILL HAS MOBILITY PROBLEMS; SHE CANNOT CLOSE THE INDEX FINGER AND THE THUMB HURTS. PATIENT IS A (B)(6) FEMALE.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; Reaction; Swelling

  MAUDE report 10332255 ↗
• InjuryMar 16, 2020Break

  IT WAS REPORTED THAT TWO PEEK TENODESIS SCREWS, AR-1530PS, WERE BEING USED IN A UCL RECONSTRUCTION PROCEDURE. WHEN THE SURGEON WENT TO INSERT ONE OF THE SCREWS INTO THE PREPARED BONE, THE DISTAL TIP OF THE DRIVER BROKE OFF INTO THE HEAD OF THE SCREW. THE SURGEON WAS UNABLE TO REMOVE THE TIP FRAGMENT FROM THE SCREW AND IT REMAINED IN THE HEAD OF THE SCREW IN THE PATIENT. THE SECOND PEEK SCREW WAS IMPLANTED WITHOUT ANY ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9838293 ↗
• InjuryDec 26, 2019Break; Difficult to Remove

  IT WAS REPORTED THAT A PEEK TENODESIS SCREW, AR-1530PS, WAS BEING USED IN A PROCEDURE. DURING INSERTION, THE TIP OF THE DRIVER BROKE OFF INTO THE HEAD OF THE SCREW AND WAS UNABLE TO BE REMOVED. THE SCREW AND TIP WERE LEFT IN THE PATIENT. PATIENT IS A MALE, (B)(6). ADDITIONAL INFORMATION PROVIDED 12/9/2019: PROCEDURE BEING PERFORMED WAS A SCAPHOLUNATE. NO ADDITIONAL INCISION WAS NEEDED. NO PHOTOS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9519347 ↗
• InjuryJun 19, 2019Break; Difficult to Remove

  IT WAS REPORTED DURING AN ELBOW MCL RECONSTRUCTION, DURING FINAL FIXATION OF THE AR-1530PS TENODESIS SCREW, THE SCREW WENT INTO THE TUNNEL FINE AND UPON REMOVING THE INSERTER HANDLE, THE TIP OF THE INSERTER BROKE OFF INTO THE HEAD OF THE SCREW. THE REP STATED THE SURGEON ATTEMPTED TO USE SUCTION AND GRAB THE BROKEN TIP WITH PICK UPS, BUT NO AVAIL. THE FRAGMENT COULD NOT BE RETRIEVED AS IT WAS REVERSED INSIDE THE HEAD OF THE SCREW, AND THERE WAS NOT ENOUGH SPACE TO INSERT ANOTHER INSERTER. X-RAYS WERE TAKEN AND THE PATIENT WAS CLOSED. THE REP STATED THE REMAINING PORTION OF THE INSERTER HANDLE WILL BE RETURNING FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8711495 ↗
• InjuryDec 5, 2018Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A TENODESIS SURGERY WHILE SCREWING IN THE SCREW, THE SCREWDRIVER TIP HAS BROKEN OFF IN THE LAST TWO TURNS. THE "PIN" OF THE SCREWDRIVER IS STUCK INTO THE SCREW. THE SURGEON WAS ABLE TO SCREW IN THE REMAINING THREADS USING A PLIERS. BOTH SCREWS WERE ALREADY OPEN ON THE TABLE, AND THEREFORE IT WAS NOT POSSIBLE TO FIND OUT WHICH OF THE TWO LOT NUMBERS WERE AFFECTED. USED LOT NUMBER 10068809 & 10079654.

  Patient problems: No Code Available

  MAUDE report 8132532 ↗
• InjuryAug 16, 2018Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A WRIST JOINT LIGAMENT RECONSTRUCTION PROCEDURE, THE TIP OF INSERTER FOR THE PEEK TENODESIS SCREW BROKE OFF WHILE INSERTING THE SCREW. THE BROKEN TIP WAS LODGED I THE HEAD OF THE SCREW AND WAS NOT ABLE TO BE RETRIEVED AND IS STILL IN THE PATIENT. *NO FURTHER DETAILS.

  Patient problems: No Information

  MAUDE report 7788236 ↗
• InjuryAug 16, 2018Migration or Expulsion of Device; Material Twisted/Bent

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ((B)(6) 2018) FOR A FAILED INTEROSSEOUS SL RECONSTRUCTION THAT TOOK PLACE ON (B)(6) 2018. THE REP STATED THAT THE PATIENT WAS FEELING PAIN AND INSTABILITY POST-SURGERY. X-RAYS REVEALED THAT THE AR-8978P (LOT: F192202) ORIGINALLY IMPLANTED ON 05/21/18 WAS NO LONGER IN THE BONE AND FLOATING IN THE JOINT CAUSING THE WHOLE CONSTRUCT TO FAIL. THE SURGEON DECIDED TO REMOVE THE PROXIMAL ROW OF CARPAL BONES IN FEAR OF ANOTHER FAILURE. AFTER REMOVING THE ANCHOR FROM THE JOINT, IT WAS NOTICED THAT THE TIP OF THE AR-8978P WAS BENT. ALL OTHER ORIGINAL IMPLANTED DEVICES REMAINED IN THE BONE, AND THE BONE WAS COMPLETELY REMOVED FROM THE PATIENT¿S BODY. NO OTHER ARTHREX PARTS WERE IMPLANTED DURING THE REVISION SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED 07/29/2018: THE REP CONFIRMED THAT THE ORIGINAL SURGERY AND REVISION SURGERY TOOK PLACE AT THE SAME FACILITY. THE PATIENT WAS AN OLDER FEMALE. THE EXACT AGE OF THE PATIENT IS UNKNOWN. THE REP CONFIRMED THAT THE FOLLOWING ARTHREX PARTS WERE IMPLANTED IN THE ORIGINAL SURGERY ON (B)(6) 2018, AND ALL WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2018. THE

  Patient problems: Pain

  MAUDE report 7788213 ↗
• InjuryNov 30, 2017Break

  IT WAS REPORTED THAT DURING A THUMB REPAIR, THE SCREW TIP BROKE DURING INSERTION. THERE WERE NO LOOSE FRAGMENTS LEFT BEHIND BUT TIP IS STILL IN THE PATIENT. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE CALL. FOLLOW-UP INVESTIGATION: X-RAY IMAGES WERE TAKEN CONFIRMING THE SCREW TIP IS IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7070399 ↗
• InjuryDec 19, 2016Break

  TENODESIS¿ SCREW WITH HANDLED INSERTER, AR-1530PS LOT: 1189487 ((B)(4) (B)(6)) BROKE OFF WHILE BEING SCREWED IN. THE BROKEN TIP WAS NOT RETRIEVED AND IS STILL IN THE PATIENT. ANOTHER PEEK-TENODESIS¿ SCREW WITH HANDLED INSERTER AR-1530PS (SAME LOT) ALSO BROKE IN THE SAME MANNER BUT THIS WAS RETRIEVED. A BIOCOMPOSITE-TENODESIS¿ SCREW WITH HANDLED INSERTER, AR-1530BC LOT: 1362942 ((B)(4) (B)(6)) WAS ALSO USED AND THE TIP OF THIS DEVICE ALSO BROKE OFF INTO THE PATIENT AND WAS NOT RETRIEVED. ONE EACH OF AN AR-1530PS AND AR-1530BC WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6184922 ↗