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NA 03.037.113Recalls & reported problems

Synthes GmbH · 130 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Synthes aiming arm is a surgical alignment tool used with rods and nails to fix broken bones, helping the surgeon place locking screws at the right angle. The 31 reports mostly describe parts jamming, bending or breaking during surgery, and instruments no longer fitting together well enough to aim properly, sometimes forcing the surgeon to swap to a different implant. Two injuries and no deaths were reported. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
31
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886982344373), received between Nov 19, 2018 and Apr 3, 2026 — classified as 2 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (23 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548); 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 2 reportsAug 2024: 1 reportsSep 2024: 3 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 2 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device-Device Incompatibility23
  • Break5
  • Material Deformation3
  • Material Twisted/Bent3
  • Device Slipped2
  • Detachment of Device or Device Component1
  • Device Difficult to Maintain1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions25
  • Insufficient Information7
  • No Code Available1
  • No Consequences Or Impact To Patient1
  • Tissue Damage1

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 3, 2026Device-Device Incompatibility

    IT WAS REPORTED THAT DURING A PROCEDURE, THE ITEMS JAMMED TOGETHER. IT APPEARS THAT THEY HAVE BECOME CROSS THREAD INTRA-OPERATIVELY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24780673 ↗
  • MalfunctionSep 12, 2025Break; Break

    IT WAS REPORTED THAT UPON HITTING THE NAIL, THE WHEEL TO TIGHTEN THE FRAME FLEW OUT IN TWO PIECES. IN ADDITION, WHEN REMOVING THE IMPACTOR AND CHECKING IT, IT WAS FOUND THAT THE TIP OF IT WAS INSIDE THE DIRECTIONAL ARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23040312 ↗
  • MalfunctionJun 16, 2025Break; Break

    IT WAS REPORTED THAT A AIMING ARM BROKE WHILE CONNECTING IT TO THE NAIL CONNECTION ARM. THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22212837 ↗
  • MalfunctionMar 17, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

    ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT? YES, ABOUT 2 MINUTES. B. WAS THE SURGERY COMPLETED SUCCESSFULLY? YES C. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NOTHING NOTICED. D. PLEASE PROVIDE PATIENT STATUS/ OUTCOME: NO PATIENT INVOLVEMENT.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 21619388 ↗
  • MalfunctionMar 17, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

    IT WAS REPORTED THAT THE DRILL SLEEVES DO NOT FIT ANY MORE IN THE AIMING ARM, THEY ARE A LITTLE BIT LOOSE AND THE SURGEON COULD HARDLY AIM THE DISTAL LOCKING.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 21619339 ↗
  • MalfunctionFeb 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

    IT WAS REPORTED THAT THE SILVER METAL RING SEEMS TO BE A LITTLE BENT, THEREFORE DRILL SLEEVE CANNOT EASILY SLIDE THROUGH HOLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 21433186 ↗
  • MalfunctionFeb 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT WITH THE 130° AIMING BRACKET FOR A 130°/12/235 NAIL, THE NAIL JAMMED IN THE BLADE HOLE WHEN INSERTING THE BLADE. THE GUIDE SLEEVE OF THE BLADE WAS BROUGHT NORMALLY TO THE CORTEX. THIS LED THE SURGEON TO TAKE THE NAIL OUT AND IMPLANT A 125°/12/235 NAIL. THIS ONE PERFORMED FLAWLESSLY. SURGERY WAS DELAYED BY AN UNKNOWN LENGTH OF TIME DUE TO THE EVENT AND WAS COMPLETED SUCCESSFULLY.

    Patient problems: Insufficient Information

    MAUDE report 21343196 ↗
  • MalfunctionJan 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY VIA TFNA LONG FOR LEFT FEMORAL TROCHANTERIC FRACTURE WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, AN INTERFERENCE CHECK WAS PERFORMED WITH THE SURGEON TO ENSURE THAT THERE WERE NO PROBLEMS WITH THE INSTRUMENT'S PATH, AND THE NAIL IN QUESTION WAS INSERTED. WHEN ATTEMPTING TO INSERT THE GUIDEWIRE IN QUESTION INTO THE BONE HEAD OVER THE DRILL SLEEVE IN QUESTION FOR TFNA, THE GUIDEWIRE WAS DISLODGED FROM THE NAIL AND INSERTED ANTERIORLY. THE GUIDEWIRE WAS OB ALTHOUGH THE CONNECTION BETWEEN THE NAIL AND THE INSERTION HANDLE IN QUESTION AND THE CONNECTION BETWEEN THE INSERTION HANDLE FOR TFNA AND THE TFNA AIMING ARM IN QUESTION WERE RETIGHTENED. THE PROXIMAL BONE FRAGMENT, WHICH HAD BEEN EXTERNALLY ROTATED, WAS INTERNALLY ROTATED, AND THE GUIDEWIRE PASSED SAFELY THROUGH THE NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON COMMENTED THAT THE SOFT TISSUE TENSION WOULD HAVE KICKED THE SLEEVE. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21231511 ↗
  • MalfunctionNov 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2024, WHEN PUTTING TOGETHER THE TRIPLE GUIDE, IT WAS NOTICED THAT THE YELLOW GUIDE SHEATH IS VERY HARD WHEN INTRODUCING THE YELLOW DRILL GUIDE, USUALLY NOT SO, INTRODUCE WITHOUT ANY PROBLEM. IN SURGERY AT THE TIME OF INTRODUCING THE TRIPLE GUIDE TO THE DIRECTIONAL ARM OF 130 DEGREES WAS ALSO SOMETHING COMPLEX, IT WAS POSSIBLE TO ENTER AND CONTINUE WITH THE SURGERY, MOMENT TO DISASSEMBLE THE PIECES, THESE 2 ARE STUCK.

    Patient problems: Insufficient Information

    MAUDE report 20590077 ↗
  • MalfunctionSep 26, 2024Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. FOR UNKNOWN REASONS, THE AIMING ARM ATTACHMENT IS DEFECTIVE. THE GUIDE WIRE AIMING DEVICE OFFSET BLOCK CAN NO LONGER BE INSERTED INTO THE GUIDE. THERE WAS NO PATIENT CONSEQUENCE. UPON MANUFACTURER INSPECTION, IT WAS FOUND THAT THE SURFACES OF THE COMPONENTS THAT COME INTO CONTACT DURING ASSEMBLY WERE BENT. THIS REPORT IS FOR A 130 DEG AIMING ARM STATIC+DYNAMIC.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20311018 ↗
  • MalfunctionSep 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED DURING A PROCEDURE ON AN UNKNOWN DATE, WHEN USING THE INSERTION HANDLE AND AIMING ARM INSTRUMENTS, THE DOCTOR TRIED TO DRILL THE DISTAL HOLE OF THE TFNA NAIL 200MM WITHOUT SUCCESS. THE DRILL SLEEVE DIDN'T MATCH WITH THE DISTAL HOLE. THEY HAVE FIVE TFNA SYSTEMS IN THE INVENTORY AND IT COULD NOT BE SPECIFIED WHICH INSTRUMENT DIDN'T WORK. THE SURGERY WAS DELAYED 5 TO 10 MINUTES. MANUAL TARGETING OF THE HOLE HAD TO BE COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE 130 DEG AIMING ARM STATIC+DYNAMIC. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20176593 ↗
  • MalfunctionSep 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED DURING A PROCEDURE ON AN UNKNOWN DATE, WHEN USING THE INSERTION HANDLE AND AIMING ARM INSTRUMENTS, THE DOCTOR TRIED TO DRILL THE DISTAL HOLE OF THE TFNA NAIL 200MM WITHOUT SUCCESS. THE DRILL SLEEVE DIDN'T MATCH WITH THE DISTAL HOLE. THEY HAVE FIVE TFNA SYSTEMS IN THE INVENTORY AND IT COULD NOT BE SPECIFIED WHICH INSTRUMENT DIDN'T WORK. THE SURGERY WAS DELAYED 5 TO 10 MINUTES. MANUAL TARGETING OF THE HOLE HAD TO BE COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE 130 DEG AIMING ARM STATIC+DYNAMIC. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20176588 ↗
  • MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 . AT THE TIME OF THE PROCEDURE, TWO DEVICES DID NOT WORK NORMALLY AND WERE LOCKED AT THE TIME OF ASSEMBLY, COMPLICATING THE SURGICAL STEP. IT HAS NO DIRECT IMPACT ON THE PATIENT SINCE THE PIECES HAVE TO BE FORCED AND WET A LITTLE SO THAT IN THE END THEY GEAR NORMALLY TO BE ABLE TO PERFORM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A 130 DEG AIMING ARM STATIC+DYNAMIC. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20041437 ↗
  • MalfunctionJul 18, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE IS NOT THREADING. THIS REPORT INVOLVES ONE (1) 130 DEG AIMING ARM STATIC+DYNAMIC. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19772675 ↗
  • MalfunctionJul 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT OSTEOSYNTHESIS FOR TROCHANTERIC FRACTURE. TO ADOPT TO CENTER POSITION, A SURGEON ATTEMPTED TO INSERT A GUIDEWIRE INTO THE AIMED POSITION OF BONEHEAD, HE ALSO ATTEMPTED TO INSERT A BLADE AS WELL. IMAGE INTENSIFIER DISCOVERED THAT THE GUIDE WIRE AS WELL AS THE BLADE WERE LOCATED AT FRONT POSITION AND THEY WERE MISALIGNED FROM MORE THAN 1CM FORWARD, INSTEAD OF STAYING CENTER LOCATION WHERE WAS THE TARGETED POSITION. EVEN THOUGH THE SURGEON REPEATEDLY CHECKED CONDITION TO MAKE SURE THE INSERTED GUIDEWIRE WAS ON CENTER POSITION OF BONEHEAD BEFORE HE INSERTED THE BLADE, FOR SOME REASON THE BLADE WAS POSITIONED AT NONINTENTIONAL PLACE. SINCE THE SITUATION WAS NOT ALLOWED, THE BLADE WAS DETACHED ONCE, AND IT WAS REINSERTED. AS FOR THE SECOND TRY, THE SURGEON INSERTED SLOWLY CAREFULLY WHILE HE WAS CONSTANTLY VIEWING TRUE-LATERAL SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH MORE THAN EXTRA 30 MINUTES. THE REASON WHY EXTRA SURGICAL TIME OCCURRED WAS TO RAMP UP FIXATION CAPACITY FOR REINSERTION, AN UNEXPECTED VOLUME OF CEMENT WAS NEEDED AND IT WAS ADDED. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES 130 DEG AIMING ARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19713108 ↗
  • MalfunctionApr 19, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

    IT WAS REPORTED THAT AN AIMING BAR IS WARPED/DEFECTIVE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 130 DEG AIMING ARM STATIC+DYNAMIC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 19148793 ↗
  • MalfunctionSep 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THAT THE PROTECTIONISTIC SHEATH, PASSES FORCED THROUGH THE DIRECTIONAL ARM. THIS REPORT IS FOR ONE (1) AIM-ARM 130° F/STAT+DYN DIST LOCK. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 17765555 ↗
  • MalfunctionJul 20, 2023Material Deformation; Material Deformation

    DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS DISCOVERED THAT THERE WERE HOLES/MARKS ON THE AIMING ARM IN QUESTION. THE SURFACE OF ARM IS NOT INTACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN AIM-ARM 130° F/STAT+DYN DIST LOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17360598 ↗
  • MalfunctionJun 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, SURGEON MANIFESTS A POOR CALIBRATION OF THE DIRECTIONAL ARM BECAUSE, WHEN MEASURING TO PLACE THE SPIRAL BLADE, IT GIVES US A LENGTH OF 105MM. THIS IMPLANT IS PASSED AND AT THE TIME OF DISMANTLING THE SCREWDRIVER, A ¿CUT OUT¿ OF THE BLADE OF MORE THAN 20MM IS EVIDENT. THE DR REQUESTS CHANGE OF THE SHEET OF 105MM FOR ONE OF 90MM. NO NEGATIVE IMPACT ON THE PATIENT. THIS REPORT IS FOR ONE (1) AIM-ARM 130° F/STAT+DYN DIST LOCK. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17126931 ↗
  • MalfunctionFeb 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

    THIS IS REPORT 1 OF 6 FOR COMPLAINT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16286482 ↗
  • MalfunctionNov 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, USING COMPLETE INSERTION FRAME, BOTH PRODUCTS IN QUESTION LOST CALIBRATION FOR THE PASSAGE OF THE DISTAL SCREW OF THE TFNA. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN AIM-ARM 130° F/STAT+DYN DIST LOCK. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15751696 ↗
  • MalfunctionFeb 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT WITH THE CONNECTING SCREW BECAME STUCK. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) AIM-ARM 130 F/STAT+DYN DIST LOCK. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13599239 ↗
  • MalfunctionAug 13, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE AIMING ARM WAS BROKEN. IT IS CROSS THREADED AND UNFIT FOR USE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) AIM-ARM 130° F/STAT+DYN DIST LOCK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12321315 ↗
  • MalfunctionJul 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE GUIDE SLEEVE WAS ALREADY HACKED WHEN IT WAS INSERTED INTO THE INSERTION HANDLE. PLACING THE GUIDE SLEEVE ON THE LATERAL CORTEX WAS DIFFICULT BUT WORKED. WHEN THE BLADE WAS DRIVEN IN, THE IMPACT INSTRUMENT OF THE HELIX BLADE DID NOT DRIVE FORWARD PROPERLY. THE IMPACTOR JAMMED. WHEN TRYING TO MOVE THE GUIDE SLEEVE OVER THE THREAD, IT COULD NO LONGER BE MOVED IN ANY DIRECTION. THE COMPLETE CONSTRUCT (WITH ALL COMPONENTS OF THE INSERTION GUIDE, TROCAR WITH COMPRESSION NUT, HELIX BLADE IMPACTOR) COULD HARDLY BE MOVED AND JAMMED. THE HELIX BLADE COULD, THEREFORE, NOT BE PLACED PROPERLY IN THE FEMORAL NECK AND CAME TO REST WITH AN OVERHANG ON THE LATERAL CORTEX. THE CONSTRUCT CONSISTING OF THE GUIDE SLEEVE AND THE AIMING ARM COULD NO LONGER BE LOOSENED. THE IMPACT INSTRUMENT COULD BE REMOVED FROM THE TROCAR AFTER LOOSENING THE CONNECTING SCREW OF THE HELIX BLADE. IN THE STERI, THE REMAINING COMPONENTS COULD ONLY BE SEPARATED WITH THE HELP OF BONE GRASPING FORCEPS AND THE PIN SPANNER. THIS RESULTED IN NOTCHES ON THE GUIDE SLEEVE. THE PROCEDURE WAS COMPLETED WITH A (15) MINUTE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12125862 ↗
  • MalfunctionJun 4, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, WHILE DISASSEMBLING THE ARM FOR WASH THE KNOB SNAPPED IN TWO. THIS REPORT IS FOR ONE (1) AIM-ARM 130° F/STAT+DYN DIST LOCK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11937579 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. One submission often covers many models, so check the product and lot details in each record.

  • Z-1239-2024 · Jan 24, 2024 · Open, Classified
    TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
  • Z-1240-2024 · Jan 24, 2024 · Open, Classified
    TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
  • Z-1246-2023 · Feb 1, 2023 · Open, Classified
    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
  • Z-1247-2023 · Feb 1, 2023 · Open, Classified
    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
  • Z-1248-2023 · Feb 1, 2023 · Open, Classified
    TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
  • Z-0126-2016 · Sep 21, 2015 · Terminated
    Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
  • Z-2091-2015 · Jun 10, 2015 · Terminated
    Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
  • Z-1600-2015 · Apr 9, 2015 · Terminated
    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
  • Z-1352-2015 · Feb 24, 2015 · Terminated
    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima

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Sources and updates

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