RIGIDLOOP 232453Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886705024544), received between Nov 25, 2019 and Mar 30, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE RIGIDLOOP COMBO REAMER/PASSING PIN 4.5MM WAS BENT. A NEW PIN WAS OPENED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726646 ↗
• MalfunctionOct 11, 2024Break; Break

  IT WAS REPORTED FROM ITALY THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE ENGINE OF THE RIGIDLOOP COMBO REAMER/PASSING PIN WAS ACTIVATED, THE TIP BROKE BEFORE PENETRATING THE BONE. IT WAS REPORTED THAT THE FRAGMENT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A 2.4 WIRE AND 4.5 CUTTER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428588 ↗
• MalfunctionOct 11, 2024Break; Break

  IT WAS REPORTED FROM ITALY THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE ENGINE OF THE RIGIDLOOP COMBO REAMER/PASSING PIN WAS ACTIVATED, THE TIP BROKE AND ONLY THE GUIDEWIRE STARTED TO TURN. IT WAS REPORTED THAT THE FRAGMENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.4 WIRE AND 4.5 CUTTER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428213 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A BRIDGE ENHANCED ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6)2024, THE COMBO BEATH PIN EA DEVICE TIP WAS BROKEN OFF WHILE DRILLING FEMORAL TUNNEL. IT WAS REPORTED THAT A NEW PIN WAS OPENED AND THE TUNNEL WAS REDRILLED TO COMPLETE THE PROCEDURE. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18795854 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A BRIDGE ENHANCED ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6)2024, THE COMBO BEATH PIN EA DEVICE TIP WAS BROKEN OFF WHILE DRILLING FEMORAL TUNNEL. IT WAS REPORTED THAT A C-ARM WAS BROUGHT IN, THE SPADE WAS LEFT IN THE PATIENT AS IT COULD NOT BE REMOVED AND A NEW PIN WAS OPENED AND THE TUNNEL WAS REDRILLED TO COMPLETE THE PROCEDURE. THERE WAS A TWENTY MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18795815 ↗
• MalfunctionMay 3, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) REPAIR RIGIDLOOP COMBO REAMER/PASSING PIN 4.5MM DEVICE BROKE 10MM INTO THE FEMUR. ACCORDING TO THE REPORT, THE BROKEN PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT NEGATIVE IMPACT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863130 ↗
• MalfunctionNov 24, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE COMBO BEATH PIN DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TIP ON THE DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870461 ↗
• MalfunctionDec 15, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE COMBO BEATH PIN DEVICE WHILE THE CLINICIAN WAS PREPARING THE FEMORAL TUNNEL USING THE COMBO DRILL WITH AM OFFSET. IT WAS REPORTED THAT THE CLINICIAN DID NOT ENGAGE THE COMBO DRILL WITH THE BONE AND STARTED TO DRILL WHILE THE END OF THE COMBO DRILL WAS AT THE NEAREST PART OF AM OFFSET SO THERE WAS NO SPACE TO TURN AROUND AND IT BROKE. IT WAS REPORTED THAT THE BROKEN TIP WAS EASILY REMOVED BY THE CLINICIAN. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE PROCEDURE. OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11007793 ↗
• MalfunctionDec 15, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE COMBO BEATH PIN DEVICE WHILE THE CLINICIAN WAS PREPARING THE FEMORAL TUNNEL USING THE COMBO DRILL WITH AM OFFSET. IT WAS REPORTED THAT THE CLINICIAN DID NOT ENGAGE THE COMBO DRILL WITH THE BONE AND STARTED TO DRILL WHILE THE END OF THE COMBO DRILL WAS AT THE NEAREST PART OF AM OFFSET SO THERE WAS NO SPACE TO TURN AROUND AND IT BROKE. IT WAS REPORTED THAT THE BROKEN TIP WAS EASILY REMOVED BY THE CLINICIAN. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE PROCEDURE. OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11007775 ↗
• InjurySep 9, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING ACL (ANTERIOR CRUCIATE LIGAMENT) SURGERY ON (B)(6) 2020, WHILE PASSING 4.5 COMBO REAMER, AFTER IT PENETRATED LATERAL CORTEX AND LATERAL SKIN OF THE PATIENT, IT WAS DISCOVERED THAT THE TIP OF THE PIN HAD BROKEN OFF. AN X-RAY WAS CALLED AND A C-ARM WAS USED TO OBTAIN THE BROKEN PIECE. ANOTHER DRILL PIN WAS INSERTED AND SURGERY WAS COMPLETED SUCCESSFULLY WITH NO FURTHER HARM TO PATIENT. THERE WAS A SURGICAL DELAY OF 20 TO 30 MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10507993 ↗
• MalfunctionApr 3, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT THE COMBO BEATH PIN EA LOADED THROUGH A FEMORAL OVER THE TOP GUIDE AND INSERTED IN THE KNEE JOINT SPACE DURING THE SURGERY. THE SURGICAL TECH MALLETED REAR OF THE COMBO REAMER TO TRY AND START IT INTO THE FEMUR FOR DRILLING. THE SURGEON DIDN¿T NOW MALLET ON THE AXIS BUT MISSED AT ANGLES. THE SURGEON THEN WANTED TO DRILL THE COMBO REAMER AND ASKED THE SURGICAL TECH TO FLEX THE LEG INTO THE APPROPRIATE POSITION. INSTEAD THE TECH PUT THE LEG INTO THE EXTENSION, PUTTING STRESS ON THE DISTAL 10MM OF THE COMBO REAMER AGAINST BETWEEN THE FEMUR AND THE END OF THE TOP GUIDE. THE TECH THEN TRANSITIONED LEG INTO APPROPRIATE POSITIONING. THE SURGEON BEGAN TO DRILL AND THE COMBO REAMER WAS NOT ENGAGING THE FEMUR AND NOT SPINNING AT ALL. THE SURGEON BACKED OVER THE TOP OF THE GUIDE OUT AND FOUND THAT THE COMBO WAS BROKEN AT APPROXIMATELY THE 10MM MARK FROM THE SPADED TIP. THE ENTIRE DEVICE WAS IMMEDIATELY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9924557 ↗
• MalfunctionDec 30, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE RIGIDLOOP COMBO REAMER/PASSING PIN 4.5MM BROKE AND THEY WERE ABLE TO REMOVE THE FRAGMENTS FROM THE PATIENT´S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 2 MINUTES DELAY WAS REPORTED. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE STATED THE FOLLOWING: "IT COULD BE POSSIBLE THAT THE BEATH PIN HIT THE ¿OVER THE TOP GUIDE¿ AS IT BEGAN REAMING THROUGH THE FEMUR WHICH CAUSED THE TIP TO BREAK. HOWEVER, I WAS PAYING CLOSE ATTENTION TO THIS AND DID NOT NOTICE THAT SCENARIO HAPPENING. OTHER THAN THAT I CAN'T IMAGINE WHAT WOULD'VE CAUSED THE BREAKAGE OTHER THAN THE FORCE OF THE PIN BEING DRILLED THROUGH THE FEMUR."

  Patient problems: Not Applicable

  MAUDE report 9531487 ↗
• MalfunctionNov 25, 2019Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE WIRE GUIDE OF THE COMBO BEATH PIN EA DEVICE WAS RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER WIRE WITH A 20 MINUTE DELAY. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9370793 ↗