NA 03.043.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982297211), received between Apr 28, 2022 and Mar 17, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K201336); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THE PIN ON THE IMPACTION CAP FOR A TIBIA NAIL ADVANCE FELL OUT MAKING THE IMPACTION CAP NOT WORK AS ADVERTISED. NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615506 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED ON JANUARY 28, 2026 THAT THE TIP OF THE CONNECTING SCREW SNAPPED OF THE REST OF THE INSTRUMENT, PREVENTING IT THE ABILITY TO CONNECT A NAIL FOR INSERTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322662 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE INSTRUMENT WERE BROKEN. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21985585 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE INSTRUMENT WERE BROKEN. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21985179 ↗
• MalfunctionFeb 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THERE WERE NO ALLEGATION AGAINST THE LOCKING SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21373336 ↗
• MalfunctionJan 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH DRILLING A HOLE FOR THE LOCKING SCREW DUE TO PRESSURE ON THE AIMING ARM SYSTEM. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SURGEON STATED THEY REPEATEDLY CAME ACROSS THE NAIL WHILE DRILLING. THE DRILLING OF THE OBLIQUE LOCK WAS NOT A PROBLEM, THE PROBLEM WAS WITH THE CONNECTION BETWEEN THE TARGET BAR AND THE NAIL. IT COULD ONLY BE RELEASED FROM THE NAIL WITH EXTREME EXERTION AT THE END. IN THE SURGEON'S OPINION, IT WAS INITIALLY CORRECTLY MOUNTED, WHICH COULD HAVE CONTRIBUTED TO THE PROBLEM, THAT THEY LOWERED THE LEG FOR THE DISTAL, OBLIQUE LOCKING, THAT IS, THE KNEE STRETCHED AND THUS CERTAINLY BROUGHT TENSION TO THE CONNECTION NAIL/TARGET BRACKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283569 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH TNA FOR THE TIBIAL DIAPHYSEAL FRACTURE. THIS CASE WAS DEPLOYED WITH A LATERAL PARAPATELLAR APPROACH. AFTER CHECKING OUTSIDE OF THE BODY, THE NAIL WAS INSERTED WITH HAMMERING. WHEN DRILLING TO INSERT A SCREW INTO THE PROXIMAL STATIC ML HOLE, THE DRILL BIT INTERFERED WITH THE NAIL. THE SURGEON DECIDED THAT SLIGHT ADJUSTMENT WAS NECESSARY, AND DRILLED TO THE PROXIMAL DYNAMIC ML HOLE. HOWEVER, THE DRILL BIT INTERFERED WITH THE NAIL AGAIN. SINCE THE AIMING ARM WAS NOT WORKING PROPERLY, DRILLING WAS PROCEEDED MANUALLY, AND THE SCREW WAS INSERTED. WHEN THE CONNECTING SCREW WAS REMOVED, THERE WAS A STRANGE SOUND. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES CONNECTING SCREW/ CANNULATED MEDIUM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189076 ↗
• InjuryMar 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A SURGERY VIA TNA LATERAL PARAPATELLAR APPROACH. WHEN THE SURGEON CONNECTED A DRIVING HEAD TO A DEVICE AND INSERTED THE NAIL WHILE TAPPING WITH A HAMMER, A LOAD WAS APPLIED ON THE CONNECTING SCREW AND THE NAIL CONNECTION, AND THE PROXIMAL END OF THE NAIL DAMAGED IN A SPLIT WAY. AFTER THE SURGEON INSERTED THE NAIL INTO THE PROPER POSITION, A DRILL BIT INTERFERED WITH THE NAIL WHEN THE SURGEON WAS DRILLING THE PROXIMAL ML HOLE. THE SURGEON RETIGHTENED THE CONNECTING SCREW AND CONFIRMED THE CONNECTION OF A HOOK OF AN INSERTION HANDLE, AND ATTEMPTED TO DRILL AGAIN, BUT THE DRILL BIT AND THE NAIL INTERFERED AGAIN. WHEN THE SURGEON ATTEMPTED TO DRILL A ROUND ML HOLE ON THE DISTAL SIDE, THE DRILL INTERFERED WITH THE NAIL AGAIN. WHEN THE SURGEON CHECKED THE SIDE IMAGE, IT WAS FOUND THAT THE CONNECTING SCREW WAS BITING SLIGHTLY DIAGONALLY INTO THE NAIL, AND THE SLEEVE WAS POINTING TO THE DORSAL SIDE. THE DRILL BIT AND THE NAIL DID NOT INTERFERE WHEN THEY WERE CHECKED BEFORE INSERTION. THE SURGEON DECIDED TO REPLACE THE CONNECTING SCREW AT HIS DISCRETION, BUT THE CONNECTING SCREW BITING THE NAIL HAD RESISTANCE AND MADE A SHARP SOUND

  Patient problems: Bone Fracture(s)

  MAUDE report 16602419 ↗
• MalfunctionJan 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A INTRA-OP CASE WHILE UTILIZING THE COMPRESSION DEVICE IN OUR ANS TNA PARAPATELLAR SET, THE COMPRESSION DEVICE WOULD NOT DISENGAGE FROM THE CONNECTING SCREW. THE SURGEON PROCEEDED TO REMOVE THE TWO DEVICES TOGETHER AS A UNIT AND SUBSEQUENTLY THREAD IN A NEW CONNECTING SCREW FROM THE TRAY. MAYBE A 10 SECOND DELAY OR ADDITION TO SURGICAL TIME. HOWEVER, WE STERILE PROCESSING REPORTED THAT THE COMPRESSION DEVICE AND CONNECTING SCREW WERE STILL COMPLETELY THREADED TOGETHER AND AS SUCH, LEFT OUT OF OUR INSTRUMENT SET. THEY TRIED SOAKING THE INSTRUMENTS TO LOOSEN THEM, CLAMPING THEM TO GET BETTER TORQUE FOR DISENGAGEMENT, ETC. TO NO AVAIL. THE LOT #S IS NOT AVAILABLE AS THE COMPRESSION DEVICE IS STILL INSIDE AND THUS NOT VISIBLE, THE CONNECTING SCREW THAT HAD SOME SORT OF CLAMP ON IT DURING THE ATTEMPT TO DISENGAGE SUSTAINED DAMAGE WHICH SKEWS THE VISIBILITY OF THE LOT #. PATIENT CONSEQUENCES OR SURGERY RESULTS ARE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) CONNECTING SCREW/ CANNULATED MEDIUM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16189831 ↗
• MalfunctionApr 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OSTEOSYNTHESIS SURGERY FOR THE TIBIAL SHAFT BONE FRACTURE WITH THE CONNECTING SCREW DEVICE. IT WAS REPORTED THAT THE DRILL COLLIDED THE NAIL HOLE AND THAT POSSIBILITY OF THE CONNECTING SCREW DEFORMATION WAS CONFIRMED. ACCORDING TO THE REPORT, THE DRILL COLLIDED IN THE DISTAL ML1 HOLE OF THE TIBIAL NAIL ADVANCED NAIL. IT WAS REPORTED THAT THE DRILL WAS IN CONTACT WITH THE POSTERIOR SIDE OF THE HOLE. IT WAS REPORTED THAT THE KNEE WAS MOVED IN A FLEXED POSITION, AND A SCREW WAS INSERTED FIRST FROM THE DISTAL ML 2 HOLE. IT WAS REPORTED THAT THE SURGEON WENT BACK TO THE DISTAL ML 1-HOLE PROCEDURE, WHERE THE SURGEON MANUALLY MANIPULATED THE PROTECTION SLEEVE TO POINT IT FORWARD BEFORE PERFORMING THE PROCEDURE, AND SOMEHOW MANAGED TO INSERT THE SCREW. IT WAS REPORTED THAT ALTHOUGH IT WAS DIFFICULT TO INSERT THE SCREW INTO THE DISTAL ML1 HOLE AS DESCRIBED ABOVE, THE SURGEON HAD BEEN CAREFUL NOT TO LOOSEN THE CONNECTING SCREW DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240651 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336. One submission often covers many models, so check the product and lot details in each record.

• Z-0229-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva
• Z-0228-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva