NA 03.010.437SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982068781), received between Apr 10, 2019 and Jul 17, 2024 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K111667); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJul 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, SURGEON WAS DOING SUPRAPATELLAR TIBIAL NAIL USING SYNTHES TISSUE PROTECTION FILM WITH A TIBIAL ADVANCE NAILING SYSTEM. THE TISSUE SLEEVE AND THE FLEXIBLE REAMER SLIPPED OFF IN THE METAL SLEEVE AND DIDN¿T NOTICE AS SURGEON WAS DOING PROXIMAL REAMING. THE ISSUE WAS NOTICED AFTER SURGERY AND BEFORE CLOSING. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19760401 ↗
• MalfunctionJul 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SLEEVE DIAMETER SEEMED ALTERED AND DID NOT FIT OVER GUIDE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. THIS REPORT IS FOR ONE 12.0 OUTER PROTEC SLV SUPRAPATELLAR -S. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643005 ↗
• MalfunctionOct 9, 2023Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2023, THAT THE PLASTIC TROCAR PIECE GOT STUCK BEHIND THE NAIL AND THE PATIENT. THEY GOT MOST OF THE PIECE OUT BUT DID LEAVE SOME ON THE PATIENT. THEY HAD TO REOPEN AND DIG OUT THE PRICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 45 MINUTES. THIS REPORT IS FOR ONE (1) 12.0 OUTER PROTEC SLV SUPRAPATELLAR -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17894708 ↗
• MalfunctionAug 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2023, THE 12.0MM SUPRAPATELLAR OUTER PROTECTION SLEEVE DISENGAGED FROM THE HANDLE AT SOME POINT IN THE PROCEDURE. WHEN THE INSERTION HANDLE WAS DISCONNECTED FROM THE NAIL AT THE END OF THE CASE, IT WAS DISCOVERED THAT THE SLEEVE HADN'T COME OUT AND WAS STUCK. IT WAS DISCOVERED THAT WHEN THE SLEEVE DISENGAGED, IT MIGRATED SOUTH OVER THE PROXIMAL PORTION OF THE NAIL. THREE OF THE PROXIMAL SCREWS WERE INSERTED THROUGH THE SLEEVE & NAIL. THE SCREWS WERE BACKED OUT AND THE SLEEVE WAS REMOVED, AND THEN THE SCREWS REINSERTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454690 ↗
• MalfunctionDec 14, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A HARVESTING KIT WITH RIA ATTACHMENT SHAFT BROKE WHEN TRYING TO REMOVE FROM INSIDE THE TIBIA. THE REAMER HEAD ON THE RIA SHAFT WAS THE 10.0MM REAMER HEAD FOR RIA 2 STERILE. THE PARTS WITH ARTICULAR SHAFT PIECES BROKE, AND ALL PARTS WERE RETRIEVED. THE ASSOCIATED PIECES WERE THE SUPRAPATELLAR DRILL GUIDE (03.010.425), HANDLE (03.010.430), AND OUTER PROTECTION SLEEVE (03.010.437). THIS HANDLE WAS TEND TO BE REAMER (357.399) AS IN THE TECHNIQUE GUIDE; THIS T SHAFT WAS MENTIONED TO BE BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980014 ↗
• MalfunctionOct 12, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED ON (B)(6)2022 , 03.010.437S WAS USED FOR THE SUPRAPATELLAR INSERTION OF TNA. WHEN THE PROTECTION SLEEVE WAS REMOVED, THE SCRUB TECH NOTICED A PIECE OF THE SLEEVE WAS MISSING. IT COULDN'T BE FOUND ON THE BACK TABLE SO THE SURGEON SCOPED THE KNEE AND FOUND THE MISSING PIECE WEDGED BETWEEN THE NAIL AND THE BONE AT THE INSERTION SITE IN THE TIBIA. THE SURGEON REMOVED WHAT HE COULD, BUT WAS FORCED TO LEAVE THE SMALL PIECE THAT WAS TOO FIRMLY WEDGED IN TO BE REMOVED. THERE WAS A SURGICAL DELAY OF 25 MINUTES TO THE CASE. ITEMS ARE NOT AVAILABLE FOR RETURN AND NO REPLACEMENT ITEM NEEDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO CONCOMITANT DEVICE REPORTED: UNK NAILS ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 12.0 OUTER PROTEC SLV SUPRAPATELLAR -S THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15590719 ↗
• MalfunctionMar 18, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE USING A 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR TIBIAL NAIL, THE PIECE OF THE SLEEVE RIPPED OFF AND WAS LODGED UNDER THE PROXIMAL END OF THE NAIL. THERE WAS A FIFTEEN (15) MINUTES OF SURGICAL DELAY DUE TO USE OF A KNEE SCOPE TO RETRIEVE THE FRAGMENTS OF THE SLEEVE FROM THE PATIENT. EVERYTHING WAS REMOVED AND THE OUTCOME WAS NORMAL. SURGEON USED A NEW PROTECTION SLEEVE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13803972 ↗
• InjuryOct 5, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A IM NAIL OF THE TIBIA PROCEDURE, THE SLEEVE BECAME STUCK IN THE PROXIMAL PART OF THE TIBIA. A PIECE HALF THE SIZE OF DIME WAS LEFT BEHIND WEDGE BETWEEN THE BONE AND THE NAIL WHILE BELOW THE SURFACE OF THE JOINT. KNEE ARTHROSCOPY WAS PERFORMED TO IDENTIFY LOOSE FOREIGN BODY. THE SURGEON DEEMED TO LEAVE THE CASE AS IT WAS SECURELY WEDGED IN THERE. THERE WAS AN UNSPECIFIED AMOUNT OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR (1) 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12579847 ↗
• MalfunctionSep 2, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A SURGICAL PROCEDURE FOR UNKNOWN REASON. WHILE COMPLETING TIBIAL NAIL, THE SURGEON WAS REMOVING THE SUPRAPATELLAR SLEEVE FROM THE KNEE. IT WAS NOTICED THAT A SMALL PIECE WAS MISSING FROM THE SLEEVE; IT IS UNKNOWN WHERE THE PIECE ENDED UP. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY REPORTED. FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SUPRAPATELLAR SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413837 ↗
• InjuryMay 20, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING THE INSERTION OF THE UNKNOWN EX TIBIAL NAIL, A PIECE OF THE SUPRAPATELLAR PROTECTION SLEEVE BROKE OFF. FRAGMENTS WERE GENERATED. ADDITIONAL INTRA-OPERATIVE X-RAYS WERE TAKEN HOWEVER, DUE TO THE RADIOLUCENT MATERIAL OF THE DEVICE, IT WAS UNABLE TO BE DETERMINED IF THE FRAGMENTS HAD REMAINED IN THE PATIENT. THERE WILL BE AN ADDITIONAL COMPUTED TOMOGRAPHY (CT) SCAN OF THE KNEE AND MAY REQUIRE ADDITIONAL SURGERY TO REMOVE THE FRAGMENT IF FOUND. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, A PIECE OF THE DEVICE POTENTIALLY REMAINED IN THE PATIENT. CONCOMITANT DEVICES REPORTED: EX TIBIAL NAIL (PART/LOT UNKNOWN, QUANTITY 1) THIS REPORT IS FOR A PROTECTION SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8624383 ↗
• InjuryMay 2, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2019, THE OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR BROKE OFF. A FRAGMENT WAS GENERATED AND COULD NOT BE FOUND, DESPITE SEARCHING WITH AN ARTHROSCOPIC CAMERA. THE SURGEON ASSUMES THAT THE FRAGMENT REMAINS IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 30 MINUTES. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8573163 ↗
• InjuryApr 10, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN ORTHOPEDIC PROCEDURE, PART OF THE OUTER PROTECTION SLEEVE FOR SUPRATELLAR TIBIAL NAIL BROKE OFF DURING USE. THERE WERE FRAGMENTS GENERATED FROM BROKEN DEVICE. SURGEON TRIED TO LOCATE THE BROKEN OFF PIECE. THE BROKEN PLASTIC FRAGMENT COULD NOT BE OBTAINED. THE SURGEON HAD TO PERFORM AN ARTHROTOMY OF THE KNEE TO MAKE SURE IT WAS NOT IN THE JOINT. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - HANDLES: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNK - GUIDE/SLEEVES/AIMING: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNK - INSERTION INSTRUMENTS: TROCAR: TR (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 12.0MM OUTER PROTECTION SLEEVE . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8500875 ↗
• InjuryApr 10, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT A RIGHT TIBIA OSTEOTOMY CORRECTION BRIDGING WITH A TIBIAL NAIL. DURING THE PROCEDURE, IT WAS NOTED THAT THE STERILE OUTER PROTECTION SLEEVE WAS MISSING A CHUNK OF PLASTIC DURING A SUPRAPATELLAR APPROACH. IT WAS OBSERVED THAT THE RESIDENT DID NOT HAVE THE INNER METAL SLEEVE FULLY SEATED INTO THE HANDHELD GUIDE. THE GENERATED FRAGMENT WAS LATER RETRIEVED FROM UNDER THE PATIENT'S KNEE CAP REGION VIA A LARGER PATELLA INCISION. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE: TIBIAL NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) OUTER PROTECTION SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8500524 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111667. One submission often covers many models, so check the product and lot details in each record.

• Z-0404-2014 · Oct 14, 2013 · Terminated
  Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabil