BIOINTRAFIX 254622Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886705013197), received between Jun 1, 2018 and Jan 12, 2026 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE BIOINTRAFIX 6-7MMX30MMTPRSCR DEVICE WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035950 ↗
• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP FROM CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE BIOINTRAFIX 6-7MMX30MMTPRSCR DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532916 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HEALTH AUTHORITY IN CHINA THAT THE PATIENT SUFFERED FROM AN INJURY TO THE ANTERIOR CRUCIATE LIGAMENT OF THE RIGHT KNEE AND UNDERWENT SURGERY AT THE HOSPITAL. THE PROCEDURE PERFORMED WAS AN ANTERIOR CRUCIATE RECONSTRUCTION ON (B)(6)2022, USING THE BIO-INTRAFIX TAPERED SCREW, 6-7MM X 30 MM DEVICE. ON THE 264TH DAY POST-SURGERY, THE PATIENT DEVELOPED REDNESS AND SWELLING OF THE WOUND. AFTER BEING ADMITTED TO THE HOSPITAL, THE PATIENT UNDERWENT DEBRIDEMENT, SUTURE, INTERNAL FIXATION, AND REMOVAL SURGERY. THE PATIENT'S POST-OPERATIVE RECOVERY WAS GOOD. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 18086704 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HEALTH AUTHORITY IN CHINA THAT THE PATIENT SUFFERED FROM AN INJURY TO THE ANTERIOR CRUCIATE LIGAMENT OF THE RIGHT KNEE AND UNDERWENT SURGERY AT THE HOSPITAL. THE PROCEDURE PERFORMED WAS AN ANTERIOR CRUCIATE RECONSTRUCTION ON (B)(6) 2023, USING THE BIO-INTRAFIX TAPERED SCREW, 6-7MM X 30 MM DEVICE. ON THE 273RD DAY POST-SURGERY, THE PATIENT DEVELOPED REDNESS AND SWELLING OF THE WOUND. AFTER BEING ADMITTED TO THE HOSPITAL, THE PATIENT UNDERWENT DEBRIDEMENT, SUTURE, INTERNAL FIXATION, AND REMOVAL SURGERY. THE PATIENT'S POST-OPERATIVE RECOVERY WAS GOOD. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 18086419 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE ON THE BIO-INTRAFIX TAPERED SCREW, 6-7MM X 30 MM DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. 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 17544798 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT THE PATIENT UNDERWENT ARTHROSCOPIC EXAMINATION OF THE LEFT KNEE, DEBRIDEMENT, AND POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION BECAUSE OF AN INJURY TO THE POSTERIOR CRUCIATE LIGAMENT OF THE LEFT KNEE. CLINDAMYCIN PHOSPHATE 0.6 G WAS GIVEN INTRAVENOUSLY BEFORE OPERATION. TENDON WAS FIXED WITH JOHNSON & JOHNSON SCREWS INTRAOPERATIVELY. 1100 ML OF INFUSION WAS GIVEN. THERE WAS LITTLE BLEEDING AND NO BLOOD TRANSFUSION DURING THE OPERATION. THE PATIENT RETURNED TO THE WARD SAFELY AFTER OPERATION. CLINDAMYCIN WAS GIVEN TO PREVENT INFECTION UNTIL THE FIRST DAY AFTER OPERATION. THE DRESSING WAS CHANGED 3 DAYS AFTER OPERATION, AND NO ABNORMALITY WAS OBSERVED IN THE WOUND, AND THE PATIENT WAS SCHEDULED TO BE DISCHARGED FROM THE HOSPITAL. FEVER OCCURRED ABOUT 1 WEEK AFTER DISCHARGE , AND THE LOCAL HOSPITAL WAS GIVEN SYMPTOMATIC TREATMENT, ANTIBIOTIC INTRAVENOUS DRIP, ETC. NO SIGNIFICANT IMPROVEMENT WAS OBSERVED. AFTER DISCHARGE, DRESSING WAS CHANGED IN THE LOCAL HOSPITAL ON TIME, THE WOUND GRADUALLY HEALED, THE WOUND HEALED WELL, AND REGULAR REEXAMINATION WAS GIVEN. LATER, THE PATIENT STILL HAD FEVER, SWELLING AND PAIN OF KNEE JOINT, AND

  Patient problems: Unspecified Infection

  MAUDE report 12781070 ↗
• MalfunctionSep 2, 2020Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY OF ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE PIECES. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10481657 ↗
• MalfunctionApr 16, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE BIOINTRAFIX 6-7MMX30MMTPRSCR BROKE OFF, ALL THE PEICES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9969863 ↗
• MalfunctionApr 16, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE BIOINTRAFIX 6-7 MM X 30 MM TPRSCR BROKE OFF, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9969847 ↗
• MalfunctionApr 16, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE BIOINTRAFIX 6-7 MM X 30 MM TPRSCR BROKE OFF, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9969785 ↗
• MalfunctionJan 6, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING AN ACL RECONSTRUCTION WHEN THE BIOINTRAFIX 6-7MM X 30MM TPRSCR WAS INSERTED, IT WAS BROKEN OFF. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 9555662 ↗
• MalfunctionAug 1, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING LEFT KNEE ARTHROSCOPY, WHEN THE BIO-INTRAFIX TAPERED SCREW, 6-7 MM X 300 MM SCREWED THE ANCHOR, AFTER 2.5 CIRCLES, THE ANCHOR WAS BROKEN. ALL THE PIECES WOULD BE RETURNED. THE SURGERY WAS COMPLETED USING ANOTHER DEVICE WITHOUT ANY PATIENT CONSEQUENCES OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8851897 ↗
• MalfunctionMar 21, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING AN ACL PROCEDURE IT WAS NOTICED THAT THE ANCHOR WAS BROKEN OFF. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE WITH NO PATIENT HARM OR TIME DELAY. THE AFFILIATE REPORTED THAT NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8441935 ↗
• MalfunctionJan 28, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL REPAIR THAT THE DISTAL TIP BROKE OFF OF THE CUSTOMER'S BIOINTRAFIX TAPERED SCREW, 7 X 30MM, WHEN IT WAS BEING INSERTED. THE SURGEON REMOVED THE BROKEN TIP LEAVING NOTHING IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SAME TYPE SCREW IN THE SAME HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281192 ↗
• MalfunctionOct 31, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THE SURGEON WAS INSERTING ONE OF THEIR 7X30MM BIOINTRAFIX TAPERED SCREW INTO ONE OF THEIR 30MM BIOINTRAFIX SHEATH AND THEY BOTH BROKE. THE SURGEON REMOVED BOTH SCREW AND SHEATH AND INSERTED TWO NEW ONES. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICES WERE DISCARDED ALREADY BY THE CUSTOMER. THE PATIENT HAD HARD BONE BUT THE SALES REPRESENTATIVE HAD NO FURTHER INFORMATION DUE TO HIM NOT BEING PRESENT. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51813.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025069 ↗
• MalfunctionSep 5, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE SURGEON NOTED THE BREAKAGE OF NAIL (ANCHOR). CHANGED THE NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7848703 ↗
• MalfunctionAug 31, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S BIOINTRAFIX SMALL SHEATH AND BIOINTRAFIX TAPERED SCREW, 7MM X 30MM, BROKE UPON INSERTION. THE SALES REP REPORTED THAT THE SURGEON IMPACTED THE SHEATH AT THE WRONG ALIGNMENT AND PUSHED THE SHEATH TOO FAR PAST THE 35 MARK CAUSING IT TO BREAK. THIS WAS NOT NOTICED UNTIL THE SURGEON INSERTED THE SCREW AND IT BROKE. THE SALES REP REPORTED THAT THE SURGEON HAD PREPARED A 7.5MM TUNNEL AND THE BONE QUALITY WAS HARD. THE SURGEON COMPLETED THE PROCEDURE WITH A LARGER SCREW AND SHEATH IN THE SAME BONEHOLE WITH NO DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837187 ↗
• MalfunctionAug 31, 2018Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT HIS BIOINTRAFIX SMALL SHEATH, 30 MM, AND HIS BIOINTRAFIX TAPERED SCREW, 7 MM X 30 MM, BROKE WHILE BEING INSERTED. THE SALES REP REPORTED THAT THE DISTAL TIP BROKE OFF AND WAS LEFT SECURELY IN THE BONEHOLE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE IN A NEW BONEHOLE WITH NO DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7836935 ↗
• MalfunctionAug 20, 2018Break; Break

  IT WAS REPORTED THAT WHILE PERFORMING AN ACL PROCEDURE AND FOLLOWING SUCCESSFUL STEPS TO PREPARE TUNNELS AND FIXATE THE GRAFT ON THE FEMORAL SIDE, SURGEON BEGAN HIS FIXATION OF THE TIBIAL SIDE. HE FOLLOWED APPROPRIATE TECHNIQUE AND INSERTED A SMALL BIO INTRAFIX SHEATH WITH EASE. HE THEN BEGAN TO INSERT THE BIOINTRAFIX SCREW (6-7) AND THE SCREW FRACTURED ONE THIRD THE WAY IN. HE OPENED A SECOND SCREW AND SHEATH AND REPEATED THE STEPS AND THE SECOND SCREW FRACTURED AT THE SAME SPOT. SALES CONSULTANT SPOKE WITH HIM AND THE STAFF, TO INQUIRE ABOUT THE HEX DRIVER THAT USED. IN MY OPINION THE FRACTURE IS CONSISTENT WITH EITHER A 23MM DRIVER OR THE POSSIBILITY OF THE SCREW NOT BEING FULLY INSERTED ON THE 30MM HEX DRIVER. NEITHER THE STAFF NOR THE SURGEON COULD CONFIDENTLY BE CERTAIN THAT THE DRIVER WAS THE 30MM. THE SURGEON IMPLANTED A MILAGRO ADVANCE AND WAS VERY SATISFIED WITH HIS FIXATION. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51899.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799759 ↗
• MalfunctionAug 20, 2018Break; Break

  IT WAS REPORTED THAT WHILE PERFORMING AN ACL PROCEDURE AND FOLLOWING SUCCESSFUL STEPS TO PREPARE TUNNELS AND FIXATE THE GRAFT ON THE FEMORAL SIDE, SURGEON BEGAN HIS FIXATION OF THE TIBIAL SIDE. HE FOLLOWED APPROPRIATE TECHNIQUE AND INSERTED A SMALL BIO INTRAFIX SHEATH WITH EASE. HE THEN BEGAN TO INSERT THE BIOINTRAFIX SCREW (6-7) AND THE SCREW FRACTURED ONE THIRD THE WAY IN. HE OPENED A SECOND SCREW AND SHEATH AND REPEATED THE STEPS AND THE SECOND SCREW FRACTURED AT THE SAME SPOT. SALES CONSULTANT SPOKE WITH HIM AND THE STAFF, TO INQUIRE ABOUT THE HEX DRIVER THAT USED. IN MY OPINION THE FRACTURE IS CONSISTENT WITH EITHER A 23MM DRIVER OR THE POSSIBILITY OF THE SCREW NOT BEING FULLY INSERTED ON THE 30MM HEX DRIVER. NEITHER THE STAFF NOR THE SURGEON COULD CONFIDENTLY BE CERTAIN THAT THE DRIVER WAS THE 30MM. THE SURGEON IMPLANTED A MILAGRO ADVANCE AND WAS VERY SATISFIED WITH HIS FIXATION. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51901.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799744 ↗
• MalfunctionAug 10, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR, IT WAS OBSERVED THAT HALF OF THE THREADS ON THE CUSTOMER'S BIOINTRAFIX TAPERED SCREW, 7X30MM DEVICE STRIPPED OFF WHEN BEING INSERTED INTO THE BIOINTRAFIX SMALL SHEATH DEVICE. THE SURGEON REMOVED THE SHEATH AND SCREW AND RE-DILATED THE BONE TUNNEL. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SAME SIZE SHEATH AND SCREW IN THE SAME BONEHOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7772301 ↗
• MalfunctionJul 19, 2018Break; Break

  THE SALES REP REPORTED DURING AN ACL PROCEDURE THAT THE CUSTOMER'S BIOINTRAFIX 7X30 TAPERED SCREW BROKE ABOUT 2/3 OF THE WAY WHILE BEING INSERTED. THE SURGEON REMOVED THE SHEATH AND SCREW AND USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THE SALES REP WAS NOT PRESENT, BUT STATED THE TENSIONER WAS USED PRIOR TO INSERTION, BUT COULD NOT VERIFY IF THE ANTIROTATION TAB WAS AT THE 3 OR 9 O'CLOCK POSITION. ALSO HE COULD NOT VERIFY THE CORTICAL OR CANCELLOUS BONE TYPE. THIS EXTENDED THE PROCEDURE ABOUT 5 MINUTES. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52307.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7702914 ↗
• MalfunctionJul 13, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE KNEE, IT WAS OBSERVED THAT WHEN THE SURGEON WAS INSERTING HIS BIO INTRAFIX TAPERED SCREW DEVICE, IT BROKE WHILE IN USE WITH THE VAPR PREMIERE 90 ELECTRODE DEVICE. IT WAS REPORTED THAT THE BROKEN PIECE WAS REMOVED, AND THE SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE FACILITY DISCARDED THE DEVICES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7687028 ↗
• MalfunctionJul 2, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR TWO OF HIS BIOINTRAFIX TAPERED SCREWS BROKE. THE SURGEON FIRST USED THE LARGER SCREW BUT IT WAS TOO LARGE AND IT BROKE UPON INSERTION. HE THEN USED THE SMALLER 7 X 30MM SCREW BUT WAS OFF AXIS, APPLIED TOO MUCH TORQUE AND AS HE TURNED HE HAND THE SECOND SCREW BROKE AT THE DISTAL END. THE SURGEON FULLY REMOVED ALL THE BROKEN SCREWS PIECES. THE SURGEON COMPLETED THE PROCEDURE WITH A THIRD ANCHOR IN THE SAME BONE HOLE AS THE PREVIOUS TWO WITH NO PATIENT CONSEQUENCES OR DELAY. THE PATIENT WAS A (B)(6) MALE WITH NO MEDICAL CONDITIONS. THE PATIENT HAD NO PRIOR SURGERIES AND HAD DECENT BONE QUALITY. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50942.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7656206 ↗
• InjuryJun 1, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT POSTOPERATIVE SCREW BREAKAGE. THE PATIENT ACCEPTED RECONSTRUCTION OF CRUCIATE LIGAMENT ON (B)(6) 2018. NO ANOMALY WAS OCCURRED IN PROCEDURE. AFTER OPERATION PATIENT RETURNED HOSPITAL FOR CHECK AND X-RAY REPORT INDICATED SCREW BROKE. NO ADDITIONAL TREATMENT WAS GIVEN. THE PATIENT HAS NO DISCOMFORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7560910 ↗