TWISTR 232000Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10886705025626), received between Mar 18, 2018 and Jan 2, 2026 — classified as 3 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RETROREAMER DEVICE WAS JAMMED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WOULD NOT OPEN WHEN CHANGING REAMER SIZE. SO THE RED RING WOULD NOT TURN. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944622 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE, WHEN USING THE RETROREAMER (6-12MM) DEVICE TO DRILL A TUNNEL WITH MINIMAL FORCE, IT WAS OBSERVED THAT THE DEVICE BROKE. IT WAS REPORTED THAT ANOTHER NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A 2-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704734 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT THE RETROREAMER (6-12MM) DEVICE TIP BROKE OFF IN THE JOINT AND WAS ABLE TO PULL IT OUT WITH THE SHEATH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO 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 23522042 ↗
• MalfunctionJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE WHILE USING THE RETROREAMER DEVICE THE DISTAL PORTION OF REAMER DETACHED FROM THE REST OF TWISTER BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331139 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED FROM JAPAN THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION OF THE KNEE IT WAS OBSERVED THAT THE SHAFT AND HANDLE OF THE RETROREAMER (6-12MM) DEVICE BROKE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE SHAFT WAS BROKEN NEAR THE HANDLE. IT WAS REPORTED THAT DURING THE SURGERY, TWISTER GUIDES WERE SET, AND RETROGRADE REAMERS WERE SET TO 10 MILLIMETERS (MM) FOR DRILLING. THE SURGEON REMOVED ONLY THE GUIDE ARM AND PROCEEDED TO FREEHAND A FEW MM UNTIL THE LINE WAS VISIBLE IN THE JOINT. SINCE THE REAMER CAME OUT IN FRONT OF THE GUIDE INSTALLATION POSITION, THE REAMER WAS INSERTED AND REMOVED AT THE VERY EDGE OF THE JOINT SURFACE ABOUT THREE TIMES IN ORDER TO BRING THE POSITION WHERE THE REAMER COMES OUT TOWARD THE BACK. WHEN THE SURGEON TURNED THE REAMER TO PULL THE 10 MM REVERSE BLADE OUT, THE SHAFT AND HANDLE COMPLETELY BROKE OFF. THE SOCKETS WERE NOT DUG AT ALL. THE 10-MM BLADE HAD LOCKED UP WITH THE BLADE OUT IN THE JOINT, SO THE SURGEON TRIED TO CLOSE THE BLADE FROM INSIDE AND OUTSIDE THE JOINT. AS A RESULT, THE REAMER WAS PULLED OUT BY REVERSING THE THROUGH-HOLE WITH THE BLADE CLOSED FROM 10 MM. IT WAS REPORTED THAT BONES WERE SHAVE

  Patient problems: Swelling/ Edema

  MAUDE report 20465947 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED BY AN AFFILIATE THAT DURING A SURGICAL PROCEDURE FOR A TWISTER SHAFT RUPTURE ON AN UNKNOWN DATE, THE RETROREAMER DEVICE SHAFT RUPTURED WHEN A SURGEON WAS TWISTING THE RED WHEEL TO RETRACT/DEPLOY THE BLADE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310118 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED FROM JAPAN THROUGH AN AFFILIATE THAT DURING A TWISTER SHAFT RUPTURE SURGICAL PROCEDURE ON AN UNKNOWN DATE, THE RETROREAMER DEVICE SHAFT RUPTURED WHEN A SURGEON WAS TWISTING THE RED WHEEL TO RETRACT/DEPLOY THE BLADE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309890 ↗
• MalfunctionSep 25, 2024Break; Degraded; Use of Device Problem; Mechanical Jam; Break; Degraded; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED FROM JAPAN THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, A RETROREAMER (6-12MM) DEVICE WAS USED. DURING SURGERY, AFTER THE GUIDE WAS INSTALLED, THE DEVICE WAS SET TO 10 MM, ATTACHED TO JACOBS, AND DRILLED. IT WAS REPORED THAT THE SHAFT PART BROKE WHEN THE DRILL WAS ADVANCED INTO THE JOINT AND THE ROLLER FOR THE REVERSE PULL BLADE WAS TURNED AND IT DID NOT CLICK EASILY. IT WAS FURTHER REPORTED THAT THE BLADE WAS STICKING OUT IN THE JOINT, SO THE SURGEON TRIED TO CLOSE IT WITH A PROBE, BUT IT WOULDN'T CLOSE, AND AFTER TOUCHING IT WITH THE PROBE SEVERAL TIMES, THE BLADE STARTED TO WOBBLE. IT WAS REPORTED THAT THE SURGEON STRUCK IT BACKWARDS WITH PLIERS AND A HAMMER, AND WAS ABLE TO INSERT IT INTO THE 4.8 BURETTE AND PULL IT OUT. THE SURGEON CHECKED THE DIRECTION OF THE HOLE WITH A 2.4K WIRE, INSERTED A 4.8 BURETTE, TAPPED A NEW TWISTER INTO THE BONY HOLE AGAIN, AND REMADE THE SOCKET. THERE WAS 30 MINUTES OF DELAY IN THE PROCEDURE. IT WAS REPORTED THAT AN X-RAY CONFIRMED THAT THERE WERE NO PIECES IN THE BODY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305187 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE THE RETROREAMER (6-12MM) DEVICE DRILL SHAFT SNAPPED FROM PROXIMAL DRILL ADJUSTER. PROCEDURE WAS PERFORMED SUCCESSFULLY AFTER OPENING ANOTHER RETRO REAMER DEVICE. THERE WAS A 15 MINUTES SURGICAL DELAY REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011326 ↗
• MalfunctionJun 6, 2024Device Contaminated During Manufacture or Shipping; Material Deformation; Device Contaminated During Manufacture or Shipping; Material Deformation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE RETROREAMER (6-12MM) DEVICE WAS NOT THE CORRECT SIZE AS IT WAS ASYMMETRICAL THAT LEFT A RIDGE IN THE TUNNEL. IT WAS SET ON 10 AND SURGEON DID NOT THINK IT REAMED TO 10. BECAUSE OF THIS WE USED AN ADDITIONAL BTB BUTTON. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT FOREIGN MATTER WAS FOUND IN THE PIN BLADE SLOT ON THE DEVICE, PRESUMABLY BONE/TISSUE DEBRIS. THERE WAS A DELAY IN THE SURGERY FOR ABOUT 40 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477913 ↗
• MalfunctionMay 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE GRAFT DID NOT PULL THROUGH WHILE USING THE RETROREAMER (6-12MM) DEVICE. ACCORDING TO THE REPORT, THE TUNNEL WAS NOT UNIFORM AND THE TUNNEL WAS NOT AT MM AS STATED ON THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19348489 ↗
• MalfunctionDec 20, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN THE UNITED KINGDOM THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE RETROREAMER (6-12MM) DEVICE FOLLOWING THE REAMING OF THE FEMORAL SOCKET USING THE TWIST DEVICE, IT WAS EVIDENT AFTER REMOVING THE DRILL THAT THE END OF THE DEVICE WAS MISSING. THIS HAD BECOME LODGED IN THE FEMORAL TUNNEL. THE LOOSE METAL TIP HAD TO BE MOVED INTO THE KNEE JOINT AND RETRIEVED THROUGH THE TIBIAL TUNNEL. THIS WAS A VERY DIFFICULT PROCESS AND ADDED A CONSIDERABLE AMOUNT OF TIME TO THE PROCEDURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 45 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 18364957 ↗
• MalfunctionAug 30, 2023Device-Device Incompatibility; Device Contaminated During Manufacture or Shipping; Device-Device Incompatibility; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TWISTR REAMER (6-12MM) DEVICE WOULD NOT ADVANCE ALL THE WAY DOWN THE 4.8 BULLET. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT FOREIGN MATTER WAS FOUND IN THE DRILL PIN AS WELL AS THE SLEEVE ON THE DEVICE WHICH WAS PRESUMABLY BIOLOGICAL MATTER. SALES REP CONFIRMED THE BULLET WAS CLEAN AND OPENED A NEW REAMER WITH THE SAME BULLET AND EVERYTHING WORKED FINE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652720 ↗
• MalfunctionApr 11, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE DISTAL TIP ON THE TWISTR REAMER (6-12MM) BROKE. 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 16718014 ↗
• MalfunctionMar 7, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TWISTR REAMER (6-12MM) DEVICE JUST BROKE. 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 16495975 ↗
• MalfunctionJan 27, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TWISTR REAMER (6-12MM) SNAPPED IN HALF DURING DRILLING. 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 16257044 ↗
• MalfunctionDec 30, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TWISTR REAMER (6-12MM) DEVICE BROKE AND GOT STUCK IN THE OPEN POSITION. 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 16080670 ↗
• MalfunctionDec 19, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY ON , IT WAS OBSERVED THAT THE TWISTR REAMER (6-12MM) DEVICE BROKE IN HALF DURING NORMAL USE. ACCORDING TO THE REPORT, THE REAMER SHAFT REMAINED IN THE OUTER SHEATH WHICH BROKE AT THE J-LOCK JUNCTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005402 ↗
• MalfunctionOct 18, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN THE NETHERLANDS THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TWISTR REAMER (6-12MM) DEVICE ¿ALMOST¿ BROKE AT THE PROXIMAL END WHERE IT WAS MOUNTED TO THE POWERTOOL. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT UPON VISUAL INSPECTION, IT WAS FOUND THAT THE DEVICE'S SHAFT WA BROKEN FROM THE BASE OF THE DEVICE'S HANDLE. 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 15625230 ↗
• MalfunctionSep 9, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION PROCEDURE ON (B)(6) 2022 IT WAS OBSERVED THAT THE TWISTR REAMER (6-12MM) DEVICE BROKE. 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 15396135 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL STUDY REPORT: EVALUATION OF HEALTHCARE OUTCOMES OF PATIENTS UNDERGOING ARTHROSCOPIC ACL RECONSTRUCTION USING DEPUY SYNTHES ACL DISPOSABLES KIT OR TWISTR¿ RETROGRADE REAMER. SOFT TISSUE INJURY AND INFECTION HAD BEEN IDENTIFIED AS THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: TWISTR RETROGRADE REAMER PROD. # (B)(4). 2 UNKNOWN PATIENTS REQUIRED REVISION SURGERY WITHIN 90 DAYS OF THEIR PRIMARY PROCEDURE.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14014523 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RETROREAMER (6-12MM) DEVICE BROKE WHERE THE SHAFT OF THE REAMER SHEATH CONNECTS TO THE PLASTIC WHILE DRILLING THE FEMORAL TUNNEL. THERE WERE NO FRAGMENTS GENERATED. 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 13446127 ↗
• MalfunctionOct 18, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT PART OF THE RETROREAMER (6-12MM) DEVICE BROKE OFF INTO THE PATIENT'S KNEE BUT WAS SUCCESSFULLY REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF APPROXIMATELY 40 MINUTES. 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 12650475 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SHAFT ON THE RETROREAMER (6-12MM) DEVICE THAT LOCKS THE OUTER SHAFT TO THE INNER REAMER BROKE WHILE REAMING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11322381 ↗
• MalfunctionDec 26, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE CANNULA PORTION OF THE CUSTOMER'S TWISTR REAMER (6-12 MM) MALFUNCTIONED, THE TOP OF IT BROKE. THE SALES REP STATED THAT ALL THE DEBRIS WAS REMOVED FROM THE PATIENT WITH A SHAVER AND NO DEBRIS WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE USING THE REAMER PORTION AS THEY WERE NEAR THE END OF THE CASE. THERE WAS NO PATIENT HARM BUT THERE WAS A 45 MINUTE SURGICAL DELAY TO THE CASE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9519800 ↗