NA 03.043.033SRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10886982298850), received between Oct 7, 2021 and Sep 15, 2026 — classified as 3 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  It was reported that the surgeon was doing a suprapatellar tibial nail for a patient with a mid shaft tibial fracture. Surgery was going as planned, until nail insertion through the sleeve. The metal portion of suprapatellar sleeve became disengaged from the silicone portion as the nail was going in. The metal portion of suprapatellar sleeve went down into the tibial bone around the proximal portion of the nail. Surgeon had to remove nail and sleeve from patient to get the metal piece out of patient¿s bone. There was concern about damage to patient¿s cartilage from the metal piece sticking outside of the silicone. A new sleeve was opened, and procedure was resumed without further incident. A surgical delay of about 10 minutes occurred for carefully removing sleeve.

  Patient problems: Insufficient Information

  MAUDE report 50771014 ↗
• MalfunctionDec 29, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED DURING A TNA SP PROCEDURE, AS SURGEONS INSERTED THE PROTECTION SLEEVE (03.043.033S) TOGETHER WITH THE WIRE GUIDE 03.043.005, THE PROTECTION SEEMS NORMAL. UPON REMOVING THE WIRE GUIDE 03.043.005 FOR THE NEXT STEP, IT WAS SEEN FROM THE C-ARM PICTURES THAT THE PROTECTION SLEEVE SEEMS DEFORMED. AS SURGEON PROCEEDED WITH THE NEXT STEP, THEY FACED DIFFICULTY TO PASS THE 12MM FLEXIBLE DRILL BIT OVER THE GUIDE WIRE. ALONG THE STEPS, AS THEY TRIED TO REAM WITH THE INTRAMEDULLARY REAMER, THEY NEEDED TO EXERT EXTRA FORCE TO PUSH THE REAMER OVER THE KINK AS WELL AS TO PULL THE REAMER OUT. IT CAN BE SEEN THAT THE METAL COMPONENT IN THE PROTECTION SLEEVE WAS PULLED OUT FROM THE ORIGINAL POSITION AS WELL. THERE WAS NO HARM DONE TO PATIENT, BUT THE SURGERY WAS SLIGHTLY DELAYED DUE TO THE ITEMS STUCK IN THE PROTECTION SLEEVE. SURGERY WAS DELAYED ABOUT 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905310 ↗
• MalfunctionJun 16, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PROTECTION SLEEVE. THE SURGEON ORDERED TNA FOR TIBIAL SHAFT FRACTURE. THE SURGEON INSERTED THE MULTI HOLE GUIDE WIRE SLEEVE LONG (8-11MM) TO UNDER PATELLA AND MADE THE ENTRY FOR THE INSERTION. AND THE SURGEON TRIED TO INSERT THE PROTECTION SLEEVE, BUT THE PATELLOFEMORAL JOINT WAS NARROW, SO THE SURGEON MANAGED TO INSERT IT BY PUSHING IT IN WITH HIS HAND. WHEN OPENING AND REAMING, THE SLEEVE WAS PRESSED AGAINST THE PATELLOFEMORAL JOINT, MAKING IT DIFFICULT TO INSERT THE TIP OF THE BLADE, BUT THE SALES REP HAD EXPLAINED TO THE SURGEON THAT TURNING THE TIP INSIDE THE SLEEVE COULD DAMAGE THE INTERNAL METAL. SO THE SURGEON USED PLIERS AND A HAMMER TO PERFORM THE REAMING. AFTER INSERTING THE END CAP AND REMOVING THE PROTECTION SLEEVE, THE INTERNAL METAL SLEEVE WAS FOUND TO HAVE PROTRUDED AND WAS PARTIALLY DAMAGED. AFTER CONFIRMING WITH A FLUOROSCOPY THAT THERE WAS NO FRAGMENT INSIDE THE BODY, THE WOUND WAS CLOSED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214570 ↗
• MalfunctionFeb 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT A SUPRAPATELLAR TIBIAL NAIL PROCEDURE ON (B)(6) 2025. THE SURGEON USED THE PROTECTION SLEEVE FOR THE REAMING PROCESS. WHILE REAMING, THE 10MM REAMER HEAD FROM THE FLEXIBLE REAMER SET BECAME JAMMED WITH THE METAL LINER OF THE PROTECTION SLEEVE, CAUSING A BRIEF DELAY OF APPROXIMATELY FIVE MINUTES. TO PROCEED WITH THE SURGERY, THEY OPENED ANOTHER PROTECTION SLEEVE AND SUCCESSFULLY COMPLETED THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21459667 ↗
• MalfunctionSep 30, 2024Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT: A. PLEASE PROVIDE PATIENT STATUS/ OUTCOME: PATIENT OUTCOME: PT SURGERY SUCCESSFUL, PART OF THE INNER METAL SLEEVE IN BURIED BELOW BONE SURFACE BUT NO POTENTIAL ISSUES ARE EXPECTED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 20333448 ↗
• MalfunctionFeb 8, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2024,THE METAL PART COMING OFF AND STRUCK OVER THE NAIL. THERE WAS PATIENT INVOLVEMENT. THE METAL PORTION OF THE PROTECTION SLEEVE GOT STUCK AROUND THE TOP OF THE NAIL. THE SURGEON HAD TO PULL IT OUT WITH A PLIERS/FORCEPS. THERE WAS NO ALLEGATION AGAINST THE NAIL. THIS REPORT IS FOR ONE (1) PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18671581 ↗
• MalfunctionDec 18, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH A TNA. THE SURGEON ATTEMPTED TO USE THE DEPTH GAUGE THROUGH THE SLEEVE IN QUESTION FOR NAIL MEASUREMENT. HOWEVER, THE SLEEVE WAS CRUSHED BY THE PATELLA AND THE DEPTH GAUGE WOULD NOT PASS THROUGH. AN OUTER SLEEVE FOR ETN WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FRAGMENTS WERE GENERATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346772 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE, THE INNER SLEEVE WAS DETACHED FROM THE PROTECTION SLEEVE AND WENT OVER THE PROXIMAL LOCKING HOLES IN THE TIBIAL NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 10 MINUTES OF SURGICAL DELAY. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318517 ↗
• MalfunctionSep 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A TIBIAL NAIL CASE, THE SURGEON CHANGED TO A SMALLER SUPRAPATELLAR SLEEVE AS THEY WERE HAVING DIFFICULTY GETTING TO THE STARTING POINT. THE SURGEON WAS EVENTUALLY ABLE TO GET TO THE STARTING POINT AND PROCEEDED WITH THE SURGERY. WHEN PUTTING IN THE PROXIMALLY LOCKING SCREWS, THE DRILL BIT IN THE S1 SCREW HOLE HIT THE NAIL. THE SURGEON WAS UNABLE TO GET THE BIT PAST THE NAIL AND SO CHOSE OTHER SCREW HOLES WHERE THE SCREWS WERE SUCCESSFULLY INSERTED. THE SCREW HOLE ALIGNMENTS WERE CHECKED PRIOR TO NAIL INSERTION AND THEY ALL LINED UP, THE SURGEON FELT THAT THE AIMING ARM WAS NOT PROPERLY LATCHED. IT WAS DISCOVERED AT THE END OF THE SURGERY THAT THE SPRING ON THE LATCH OF THE AIMING ARM WAS NOT WORKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT OUTCOME. THERE WAS A SURGICAL DELAY OF 45 MINUTES. NO FRAGMENTS WERE GENERATED. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819659 ↗
• MalfunctionAug 28, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE, THE SLEEVE IN QUESTION DEFORMED DURING REAMING. ALL GENERATED FRAGMENTS WERE REMOVED FROM THE PATIENT WITHOUT ANY ADDITIONAL INTERVENTION. THERE WAS NO REPORTED ADVERSE PATIENT OR PROCEDURE IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633571 ↗
• InjuryAug 9, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS DOING A SUPRAPATELLAR TIBIAL NAIL USING THE TNA. AFTER DISTAL LOCKING THE NAIL HE WENT TO DO PROXIMAL LOCKING THROUGH THE AIMING ARM. THE DRILL BIT WAS HITTING THE NAIL AND NOT TARGETED CORRECTLY. HE HAD TO MANIPULATE THE LEG AND TRY SEVERAL TIMES TO GET THE DRILL BIT TO PASS THROUGH THE NAIL. AFTER ACHIEVING FINAL FIXATION AND REMOVING THE NAIL, THE METAL SLEEVE INSIDE PROTECTION SLEEVE CAME APART FROM THE PLASTIC OUTER SLEEVE AND REMAINED IN THE JOINT WHEN PULLING OUT THE DEVICE. THE SURGEON HAD TO AGGRESSIVELY PULL ON THE METAL INSERT TO REMOVE IT AND THE EDGES OF THE METAL SLEEVE SCRAPED AGAINST THE PATIENT'S ARTICULAR CARTILAGE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Damage to Ligament(s)

  MAUDE report 17491879 ↗
• MalfunctionAug 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482547 ↗
• MalfunctionAug 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY WITH PROTECTION SLEEVE, TROCAR AND TNA NAIL. AFTER INSERTING THE PROTECTION SLEEVE THE TROCAR BECAME STUCK. THE SURGEON STOPPED USING THE PROTECTION SLEEVE AND USED THE ETN SLEEVE TO COMPLETE THE PROCEDURE. ADDITIONALLY, WHILE USING A 9MM TNA NAIL, THE DRILL BIT AND NAIL INTERFERED WHEN DRILLING A LATERAL LOCKING DRILL IN THE PROXIMAL ML DIRECTION OVER THE DEVICE. THE OPERATION WAS COMPLETED WITH A FREEHAND DRILL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481676 ↗
• MalfunctionAug 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED ON JULY 18, 2023 THAT , THE METAL IS BENT. THERE WERE NO OPERATION OR PATIENT INVOLVED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451570 ↗
• MalfunctionAug 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SUPRAPATELLAR NAIL SURGERY ON (B)(6) 2023, THE SLEEVE WAS TIGHT BECAUSE OF A TIGHT PATELLA FEMORAL JOINT, AND CAUSED THE REAMERS AND DRILL TO BE ¿GRABBED¿. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE EVENT OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450096 ↗
• MalfunctionJul 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE METAL PORTION OF THE SLEEVE GOT STUCK ON THE END OF THE NAIL, AND THE RUBBER PORTION WAS PULLED OUT. THE REMAINING METAL INSERT THEN HAD TO BE PULLED OUT. THERE WAS NO NEGATIVE PATIENT IMPACT. THIS REPORT INVOLVES ONE PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377307 ↗
• MalfunctionJul 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 AS THE SURGEON WAS BEGINNING TO USE THE 12MM OPENING REAMER FOR THE TIBIAL NAIL, THE OPENING REAMER CAUGHT THE MIDDLE INSIDE OF THE 8-11MM PROTECTION SLEEVE AND DESTROYED THE INSIDE. THE SURGEON THEN TOOK OUT THE SLEEVE AND AND REPLACED WITH THE ONLY AVAILABLE 8-13MM. CASE PROCEED AS NORMALLY WITH NOT DERBIES LEFT INSIDE THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SURGICAL DELAY OF THREE(3) MINUTES. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17292419 ↗
• MalfunctionJun 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE WIRE SLEEVE WAS DAMAGED AS IT WAS A VERY TIGHT JOINT TO TRY AND GET THE PROTECTIVE SLEEVE THROUGH. THE SURGEON USED LIGHT MALLOT TAPS TO TRY AND ADVANCE THE WIRE SLEEVE DOWN TO THE BONE. THE 3.2 WIRE NO LONGER PASSES THROUGH THE HOLES IN THE SLEEVE. THE PROTECTION SLEEVE WAS DISCARDED AND WIRE SLEEVE DAMAGED. PROCEDURE WAS COMPLETED SUCCESSFULLY USING A 2ND SET FOR A NEW WIRE SLEEVE. NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080672 ↗
• MalfunctionMar 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SALES REP BECAME AWARE IN THE MIDDLE OF SURGERY THAT PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE CAME APART FROM THE TNA NAIL. ALSO HAD PROBLEMS WITH TRIPLE SLEEVE, NOT LINING WITH THE CAPITAL PLANE. HE TRIED TO GET IT SENT BACK. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482289 ↗
• MalfunctionJan 19, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON DECEMBER 26, 2022, WHILE ATTEMPTING TO USE A TNA OUTER SLEEVE FOR A SUPRAPATELLAR NAIL, THE SLEEVE WAS TIGHT IN THE PATELLOFEMORAL JOINT. ADDITIONALLY THE PATIENT WAS VERY OBESE NOT ALLOWING SLEEVE TO ENTER THE JOINT AS MUCH AS THE SURGEON NEEDED. THE SURGEON ACTIVATED THE DRILL WITH THE OPENING DRILL BIT INSIDE OF THE AND OSCILLATED. THE SLEEVE WAS DAMAGE AND ANOTHER ONE WAS OPENED AND THE SURGERY PROCEEDED. ULTIMATELY THE SURGEON DECIDED TO PROCEED WITH THE SURGERY WITHOUT ANY SLEEVE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 5 MINUTES. THERE WAS NO PATIENT CONSEQUENCES/ OUTCOMES REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16212325 ↗
• MalfunctionJan 18, 2023Break; Break

  IT WAS REPORTED THAT THE (B)(6) 2022, THE INNER METAL CASING ON OUR PROTECTION SLEEVE/FLEX LONG FOR NAILS 8-11 WAS BROKEN OFF WHILE REAMING AND WENT INTO A PATIENT'S KNEE. HAD TO DO AN ARTHROTOMY AT THE END OF THE CASE TO GET THE PIECE OUT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH 30MINS OF SURGICAL DELAY. FRAGMENTS WERE GENERATED BUT WERE NOT REMOVED EASILY. THEY HAD TO DO AN ARTHROTOMY. THE PATIENT EXPERIENCED CLINICAL OUTCOME SUCH AS LONGER SURGERY AND EXTRA INCISION. OTHER MEDICAL INTERVENTION DONE AS AN ARTHROTOMY TO REMOVE THE PIECE OF METAL IN THE JOINT SPACE WAS PERFORMED. CONCOMITANT DEVICE REPORTED - UNK - NAILS ((PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194025 ↗
• MalfunctionNov 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE INNER SLEEVE IN QUESTION GOT CAUGHT DURING ENTRY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780754 ↗
• MalfunctionSep 23, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, INNER METAL PORTION OF SUPRA-PATELLAR SLEEVE BOUND AND SHREDDED BY REAMER HEAD. SLEEVE REMOVED FROM FIELD AND DISCARDED. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469726 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 THE INNER METAL PART OF PROTECTION SLEEVE CAME OUT INSIDE THE JOINT, FREE FROM THE OUTER PLASTIC PART OF THE SLEEVE. ALL PIECES WERE RETRIEVED. THERE WAS 2 MINS OF SURGERY DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED AND ALSO REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412272 ↗
• InjurySep 13, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE METAL ASPECT OF THE TNA SUPRAPATELLAR OUTER SLEEVE BECAME DISLODGED FROM THE OUTER SLEEVE DURING INSERTION OF TIBIA ROD. THE METAL SLEEVE TRAVELLED DOWN INTO THE TIBIA AROUND THE ROD. IT WAS DIFFICULT TO REMOVE AS A PORTION OF IT WAS ALSO BEHIND THE PATELLA-FEMORAL JOINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WERE FRAGMENTS GENERATED WHICH WERE REMOVED BY ADDITIONAL INTERVENTION. THIS REPORT INVOLVES ONE PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15411254 ↗