ARTHRO-PIERCE 7209498Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03596010474537), received between Dec 19, 2019 and Feb 11, 2026 — classified as 7 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE FORCEPS OF ONE (1) ARTHROPIERCE 45 DEGREE LEFT BROKE WHILE INSIDE THE PATIENT. THE PIECES WERE REMOVED FROM THE PATIENT ALTHOUGH THE METHOD OF REMOVAL REMAINS UNKNOWN. IT IS ALSO UNKNOWN HOW THE PROCEDURE WAS RESUMED; HOWEVER, THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314611 ↗
• MalfunctionJan 27, 2026Fracture

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, WHEN AN ARTHROPIERCE WAS REMOVED, IT WAS EVIDENT THAT IT HAD A VERY STRANGE CURVE. THE SAME WAS OBSERVED WHEN IT WAS INSERTED INTO THE JOINT, AND WHEN THE CAMERA ZOOMED IN, IT BECAME CLEAR THAT IT WAS FRACTURED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192384 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT, DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT THE ARTHROPIERCE 45 DEGREE LEFT TO THE LEFT, IT BROKE INSIDE THE PATIENT. THE TIP WAS REMOVED WITH THE AID OF A GRASPER FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872770 ↗
• MalfunctionNov 14, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE LEFT TIP OF THE ARTHROPIERCE WAS BENT AND THE JAW BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556435 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE ARTHROPIERCE 45 DEGREE LEFT CLAMP BROKE; NO PIECES FELL INSIDE THE PATIENT AND THE PROCEDURE WAS PERFORMED WITHOUT ANY SURGICAL DELAY USING AN EQUIVALENT S+N BACKUP, WITH NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279186 ↗
• MalfunctionJul 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE UPPER JAW OF THE ARTHROPIERCE 45 DEGREE LEFT FORCEP BROKE DURING INTERACTION WITH THE WIRES. THE BROKEN PIECE FELL INTO THE PATIENT AND WAS COMPLETELY REMOVED WITH A GRASPER FORCEPS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO HARM OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22622488 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INSTABILITY PROCEDURE, THE ARTHROPIERCE CLAMP BROKE INSIDE THE PATIENT'S JOINT WHEN PERFORMING THE LABRUM STITCH. THE FRAGMENT WAS REMOVED FROM THE PATIENT WITH SALINE PRESSURE. THE SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088346 ↗
• MalfunctionOct 13, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ARTHROPIERCE CLAMP BENT AND BROKE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436472 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE ARTHROPIERCE WAS INSERTED AND CAME INTO CONTACT WITH THE TISSUE, THE TIP CAME OFF. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625990 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN INTRODUCING THE ARTHROPIERCE CLAMP THROUGH THE PATIENT'S MUSCULATION/TENDON, THE DOCTOR WENT TO OPEN THE CLAMP TO CATCH THE WIRE, NOTICED THAT IT DID NOT HAVE THE TOP TIP THAT CLOSES THE CLAMP, IT BROKE INSIDE THE PATIENT. AFTER FINDING IT THROUGH SCOPIA, IT WAS FOUND THAT IT WAS NOT INSIDE THE PATIENT AND IT WAS EXPULSED WITH THE PRESSURE OF THE SERUM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS OR HARM TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464090 ↗
• MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, THE ARTHROPIERCE CLAMP DISASSEMBLED INTO 3 PARTS DUE TO BREAKAGE OF THE DEVICE JOINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235496 ↗
• MalfunctionMay 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A TRAINING FOR A CUFF ARTHROSCOPY, THE PIPE DUCK ON THE ARTHROPIERCE 45 BROKE. THE FRAGMENTS WERE REMOVED USING GRASPERS TWICE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235108 ↗
• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE ARTHROPIERCE 45 FORCEPS WERE PASSED OVER THE TENDON, THEY WERE FORCED AND BROKEN IN THE CAVITY. THE MATERIAL WAS COMPLETELY REMOVED AND THERE WERE NO TRACES LEFT INSIDE THE CAVITY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395852 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED THAT WHEN THE ARTHROPIERCE WAS INTRODUCED INTO THE CAVITY, IT BROKE DUE TO THE FORCE EXERTED AT THE ENTRANCE TO THE CAVITY. THE BROKEN FRAGMENTS WERE REMOVED USING A GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007732 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE ARTHROPIERCE 45 DEGREE LEFT BROKE INSIDE THE JOINT. THE SURGEON WAS ABLE TO REMOVE THE TIP OF THE BROKEN TWEEZERS WITH THE HELP OF ANOTHER TWEEZERS. A DELAY GREATER THAN 30 MINUTES WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287856 ↗
• MalfunctionMar 10, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN STITCHING SOFT TISSUES IN THE JOINT, THE ARTHROPIERCE JAMMED, AND THE PHYSICIAN REMOVED THE INSTRUMENT. ON THE OPERATING TABLE, WHEN EXAMINING THE DEVICE, IT FELL IN TWO PARTS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521216 ↗
• InjuryMar 6, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE ARTHROPIERCE TWEEZERS' TIP BROKE. IT WAS REMOVED AND NOTHING WAS LEFT IN THE PATIENT. THE SURGERY WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491464 ↗
• InjuryJan 10, 2023Break; Fracture; Break; Fracture

  ADVISED BY CUSTOMER THAT AN INSTRUMENT HAS BROKEN INSIDE A PATIENT. CURRENTLY NO FURTHER INFORMATION AT ALL REGARDING THE INSTRUMENT, FAULT OR CIRCUMSTANCES. VISITING THE HOSPITAL TOMORROW TO OBTAIN FURTHER DETAILS AND INSTRUMENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135363 ↗
• InjuryNov 29, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER PLACING THE ANCHOR, THE SPECIALIST PROCEEDED TO PASS THE POINT WITH THE FORCEPS ARTROPIERCE LEFT BUT AT THE TIME OF INTRODUCING IT AND PASSING THE LABRUM, HE NOTICED THAT THE TIP WAS BENT, IMMEDIATELY PROCEEDED TO EXTRACT IT AND THE TIP OF ABOUT 2MM REMAINED ON THE WAY INTO THE TISSUE, THE SPECIALIST TRIED TO EXTRACT IT BUT COULD NOT, THEREFORE, DECIDED TO LEAVE IT INSIDE ARGUING THAT THERE IS NO RISK TO THE PATIENT AS IT WAS NOT FLOATING INSIDE THE JOINT. IN ORDER TO PASS THE STITCH TO THE LABRUM, THE ARTROPIERCE 45° RIGHT FORCEPS WERE USED THUS COMPLETING THE PROCEDURE. THE PATIENT'S HEALTH WAS NOT AFFECTED. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15880598 ↗
• InjuryJun 10, 2022Break; Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY, THE IMPLANT WAS PLACED AND THE SPECIALIST PROCEEDED TO PLACE THE STITCHES USING THE ARTHROPIERCE'S CLAMP TO MAKE HIS STITCHES. AT THE MOMENT OF PASSING THE FIRST STITCH AND PASSING THROUGH THE TISSUE, THE CLAMP BROKE, THE DOCTOR TAKE OFF THE CLAMP BUT WAS UNABLE TO REMOVE THE BROKEN FRAGMENT FROM THE PATIENT, THUS THE PIECE WAS LEFT INSIDE THE ANATOMY. THE PROCEDURE WAS COMPLETED USING AN ACCUPASS AS A BACKUP DEVICE, BUT IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14655133 ↗
• InjuryMay 18, 2022Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHILE SUTURING WITH THE ANCHOR THREADS, THE ARTHROPIERCE FORCEPS BROKE INSIDE THE PATIENT'S SHOULDER. A PIECE OF THE FORCEPS WAS REMOVED, AND THEN ANOTHER PIECE WAS IDENTIFIED INSIDE THE SHOULDER WITH A X-RAY, REQUIRING A NEW REMOVAL. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY. PATIENT'S HEALTH CONDITION IS STABLE. NO FURTHER COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429516 ↗
• InjuryMay 9, 2022Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, WHEN INTRODUCING THE ARTHROPIERCE INTO THE TENDON, THE TIP BROKE, AND THE SURGEON REMOVED THE PIECE THAT BROKE WITH A GRASPER. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED; HOWEVER, NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338028 ↗
• MalfunctionSep 7, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT THE ARTHROPIERCE HAD A MISSING PART. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT DEVICE TOP JAW SHEARED OFF WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431236 ↗
• InjuryMay 25, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE ARTHROPIERCE 45 DEGREE BROKE INTO THE PATIENT. ALL THE PIECES WERE REMOVED WITH A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11875878 ↗
• MalfunctionMar 22, 2021Break; Break

  IT WAS REPORTED THAT THE ARTHROPIERCE TIP WAS BROKEN. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED, HOW THE PROCEDURE WAS FINISHED, AND IF A DELAY OCCURRED. HOWEVER, NO PATIENT COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548091 ↗