ENDOBUTTON 7207220Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03596010375315), received between Aug 31, 2017 and Dec 31, 2025 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING ACL RECONSTRUCTION SURGERY, THE 2.4 MM TROCAR PIN WAS PRODUCING METAL DEBRIS WHILE DRILLING. THE DRILL AND WIRE WERE REMOVED FROM THE JOINT, AND A SHAVER WAS USED TO CLEAR THE INTRA-ARTICULAR SPACE OF THE METAL DEBRIS. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933322 ↗
• MalfunctionFeb 23, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, FORTY (40) TROCAR-TIP PASSING HAD "METAL SHAVINGS" COMING OFF WHEN DRILLING. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR CONMED DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18771498 ↗
• MalfunctionOct 19, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE STERILE PACKAGING OF A PIN PASSING WAS DAMAGED. IN THE IMAGES PROVIDED, IT WAS NOTICED THAT THE STERILE PACKAGING WAS PUNCTURED, IT HAD SMALL HOLES IN IT. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15634146 ↗
• InjuryOct 17, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE PASSING PIN LEFT SHAVINGS OF METAL IN THE INTERCONDYLAR NOTCH WHEN IT WAS DRILLED THROUGH THE 6MM OFFSET GUIDE. ALL THE METAL PIECES WERE REMOVED FROM THE PATIENT BY SHAVER SUCTION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS DOING WELL, NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616252 ↗
• InjuryOct 17, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE PASSING PIN LEFT SHAVINGS OF METAL IN THE INTERCONDYLAR NOTCH WHEN IT WAS DRILLED THROUGH THE 6MM OFFSET GUIDE. ALL THE METAL PIECES WERE REMOVED FROM THE PATIENT BY SHAVER SUCTION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS DOING WELL, NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616116 ↗
• InjuryOct 10, 2022Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE PASSING PIN, 2.4MM X 17 TROCAR HAD EXTREME METAL ABRASION OF THE WIRE, THE CHIPS WERE REMOVED WITH DIFFICULTY BY IRRIGATION AND TWEEZERS. NON-SIGNIFICANT SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15573311 ↗
• InjurySep 30, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE PASSING PIN LEFT SHAVINGS OF METAL IN THE INTERCONDYLAR NOTCH WHEN IT WAS DRILLED THROUGH THE 6MM OFFSET GUIDE. ALL THE METAL PIECES WERE REMOVED FROM THE PATIENT BY SHAVER SUCTION. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS DOING WELL, NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514080 ↗
• InjuryJan 3, 2022Break; Break

  IT WAS REPORTED THAT, DURING A ACL RECONSTRUCTION, WHILE DRILLING THE FEMORAL CANAL WITH A PIN PASSING 2.4MM TROCAR THE PIN BROKE INTO TWO FRAGMENTS. THE SMALL PIECE GOT STUCK IN THE PATIENT'S FEMUR AND THE LARGE PIECE WAS REMOVED IMMEDIATELY. TO EXTRACT THE SMALL FRAGMENT, THE SURGEON HAD TO DRILL A CHANNEL IN THE FEMUR WITH A CANNULATED DRILL OF 4.5 MM, PUNCHING ON THE REMAINDER OF THE PIN, THEREBY DRILLING A WIDER CHANNEL SO THAT THE FRAGMENT OF THE PIN FRAGMENT COULD FREELY EXIT THE BONE. SURGERY WAS RESUMED AFTER A DELAY GREATER THAN 60 MIN, BUT IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142470 ↗
• MalfunctionSep 3, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE PASSING PIN HAD A HIGH METAL ABRASION. FRAGMENTS FELT INSIDE THE PATIENT BUT WERE REMOVED WITH A SHAVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO OTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 10491644 ↗
• MalfunctionMar 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE PASSING PIN BROKE INSIDE THE PATIENT. ALL PIECES WERE REMOVED FROM THE PATIENT WITH A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE. NO PATIENT INJURY OR OTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 9809329 ↗
• InjurySep 28, 2018Smoking; Failure to Advance

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE DEVICE WAS BEING INSERTED THE PIN WAS NOT ADVANCING AND SMOKE CAME OUT. THE PIN WAS REMOVED IN ORDER TO SEE WHAT HAPPENED, IT WAS NOTICED THAT THE PIN BROKE INSIDE THE PATIENT. A MODERATE INCISION WAS MADE IN ORDER TO REMOVE THE BROKEN PIECES, ALL THE PIECES WERE REMOVED. BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7919138 ↗
• MalfunctionSep 27, 2018Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE DOCTOR ASK FOR THE DEVICE, IT CAME OUT OF THE PACKAGE BENT. NO PATIENT INJURY WAS REPORTED. BACK-UP DEVICE WAS NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915007 ↗
• MalfunctionSep 18, 2018Smoking

  IT WAS REPORTED THAT DURING THE PROCEDURE THE DOCTOR OBSERVED A KIND OF SMOKE THAT CAME OUT AND NOTICED SOME PARTICLES (SHAVINGS) ON THE SCREEN THAT WAS CAUSED BY THE BROKEN PIN, ONE PART OF THE PIN WAS INSIDE THE TIBIAL TUNNEL AND THE OTHER WAS WITHIN THE CANNULATION OF THE DRILL. THE SURGEON REMOVED ALL THE PARTS FROM THE PATIENT AND PASSED A DRILL WITHOUT A GUIDE. THE PROCEDURE WAS COMPLETED AND NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7885548 ↗
• MalfunctionSep 8, 2018Break

  IT WAS REPORTED THAT DOCTOR PERFORMED THE ARTHROSCOPY AND HE STARTED TO REPAIR THE ACL. HE PUT THE GUIDE IN C ON THE TIBIAL SIDE AND IT WAS PUT IT IN THE CORRESPONDING PART, THE MOTOR WITH THE 2.4 GUIDE WAS PASSED, DOCTOR PASSED IT THROUGH THE GUIDE IN C, THE GUIDE WAS REMOVED AND THE DRILL FOR THE FEMUR WAS PASSED ACCORDING TO THE DIAMETER OF THE GRAFT. THEY WERE STARTING TO PASS THE DRILL WHEN THE GUIDE OF 2.4 WAS BROKEN, LEAVING A PIECE INSIDE THE BONE, ONE HOUR WAS NECESSARY TO REMOVE THE BROKEN PIECE, FINALLY ALL THE PIECE WAS REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 7858545 ↗
• MalfunctionAug 13, 2018Material Disintegration

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, WHEN THE DOCTOR PASSED THE GUIDE (2.4 MM), THE GUIDE STARTED TO RELEASE SOME PARTICLES OF THE MATERIAL THAT IS MADE AND THESE WERE INSIDE THE PATIENT. SOME PARTICLES WERE CLEANED, BUT SOME OF THEM REMAINED INSIDE THE PATIENT (THERE WERE TOO SMALL). THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7776292 ↗
• MalfunctionApr 19, 2018Metal Shedding Debris

  IT WAS REPORTED THAT WHEN THE 2.4 GUIDE WAS PASSED THROUGH THE 7MM FEMORAL GUIDE, METAL PARTICLES FROM THE PIN WERE GENERATED WHEN THE MOTOR WAS ACTIVATED. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7443172 ↗
• MalfunctionDec 19, 2017Break

  IT WAS REPORTED THAT AT THE MOMENT OF DRILLING THE TIBIAL CANAL, THE DRILL BIT BROKE THE GUIDE AND A DIFFERENT DRILL PATH THAN PLANNED WAS DONE. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7128944 ↗
• MalfunctionOct 25, 2017Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN AND A FRAGMENT REMAINED INSIDE THE PATIENT. KELLY FORCEPS IN ORDER TO REMOVE THE FRAGMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6978124 ↗
• MalfunctionOct 18, 2017Metal Shedding Debris

  IT WAS REPORTED THAT THE PIN PASSING 2.4MM TROCAR 17 DROPPED METAL SHREDS AFTER BEING PASSED THROUGH THE TIBIA, THE TRACES WERE REMOVED WITH THE SHAVER. A SECOND PASSING PIN WAS USED AND IT ALSO DROPPED METAL SHREDS WHEN IT WAS PASSED THROUGH THE TIBIA AND THE FEMUR. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6958924 ↗
• MalfunctionOct 18, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PIN PASSING 2.4MM TROCAR 17 DROPPED METAL SHREDS AFTER BEING PASSED THROUGH THE TIBIA, THE TRACES WERE REMOVED WITH THE SHAVER. A SECOND PASSING PIN WAS USED AND IT ALSO DROPPED METAL SHREDS WHEN IT WAS PASSED THROUGH THE TIBIA AND THE FEMUR. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6958923 ↗
• MalfunctionAug 31, 2017Break

  IT WAS REPORTED THAT THE PASSING PIN BROKE DURING USE. THE BROKEN TIP WAS REMOVED FROM THE PATIENT AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. A SHORT DELAY WAS REPORTED WITH NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6835955 ↗