Arthrex® AR-7234Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867041677), received between Jan 10, 2018 and Nov 26, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1370C BIOCOMPOSITE INTERFERENCE SCREW AND AN AR-4020C-07 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW RIPPED THE SUTURE TIED TO THE GRAFT DURING THE FIXATION OF THE GRAFT TO THE FEMUR. THIS CAUSED THE GRAFT TO HAVE TO BE WHIP-STITCHED MULTIPLE TIMES. THE CASE WAS COMPLETED USING A BIOTENODESIS SCREW 8X23MM. THIS WAS DISCOVERED DURING AN MPFL RECONSTRUCTION PROCEDURE ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 11/6/2024: THE SUTURE THAT BROKE WAS AN AR-7234 FIBERLOOP. THE CASE SUTURE WAS REMOVED AND REPLACED WITH ANOTHER AR-7234 FIBERLOOP. THE ANCHORS WERE ALSO REMOVED, AND AN AR-1580BC BIOCOMPOSITE-TENODESIS SCREW WAS USED. THERE WAS NO DELAY IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788096 ↗
• MalfunctionJun 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH SEMITEDINOSUS TENDON THE DEVICE FELL APART. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY 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 19630043 ↗
• MalfunctionJun 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH SEMITEDINOSUS TENDON THE DEVICE FELL APART. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY 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 19629999 ↗
• MalfunctionJun 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH SEMITEDINOSUS TENDON THE DEVICE FELL APART. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY 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 19629951 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN AR-7234 FIBERLOOP, AR-2261 BICEPS BUTTON AR-2262 BUTTON INSERTER AND AR-2263 DRILL WERE INVOLVED IN A DISTAL BICEPS REPAIR, THE PATIENT SUFFERED A CONTINUING NERVE ISSUE AFTER THE SURGERY. REVISION SURGERY (B)(6) 2022 TO REMOVE BUTTON AND PUT IN ANCHOR.

  Patient problems: Nerve Damage

  MAUDE report 15137723 ↗
• InjuryJan 10, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR THE TIP OF THE AR-13991N NEEDLE BROKE OFF. THEY WERE UNAWARE THAT THE TIP WAS STILL IN THE PATIENT UNTIL IT SHOWED UP ON X-RAY. IT WAS NOT RETRIEVED. DURING THE SAME PROCEDURE THE FIBERLOOP #2 SUTURE, AR-7234, BROKE OFF. IT IS STILL IN THE PATIENT. THERE IS A REVISION SURGERY SCHEDULED ON (B)(6) 2017 TO REMOVE THE FIBERLOOP AND POSSIBLY THE NEEDLE TIP. FOLLOW-UP INVESTIGATION: DURING THE (B)(6) 2017 PROCEDURE THE TIP OF THE SUREFIRE SCORPION NEEDLE, AR-13991N, LOT 10113253 ((B)(4)) BROKE OFF AND REMAINED IN THE PATIENT. ALSO, THE NEEDLE TIP AND SOME SUTURE BROKE OFF AND REMAINED IN THE PATIENT FROM THE AR-7234, FIBERLOOP, #2 BLUE, LOT 10026082 ((B)(4)). THE REVISION SURGERY TOOK PLACE ON (B)(6) 2017, AT A DIFFERENT FACILITY THEN THE ORIGINAL SURGERY AND WAS PERFORMED BY A DIFFERENT SURGEON THAN THE ORIGINAL PROCEDURE SURGEON. DURING THE REVISION THE SURGEON WAS ABLE TO REMOVE THE (B)(6) 2017 UNRETRIEVED SUTURE AND UNRETRIEVED NEEDLE TIP FROM THE AR-7234 FROM THE PATIENT. THE (B)(6) 2017 UNRETRIEVED NEEDLE TIP FROM THE AR-13991N SUREFIRE SCORPION NEEDLE WAS NOT FOUND AND REMAINS UNRETRIEVED. PATIENT WAS A MALE, (B)(6). DEVICES AND AN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7178426 ↗