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NA 314.743Recalls & reported problems

Synthes GmbH · DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA · Class 2

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

Quick summary

This Synthes RIA drive shaft is used with the RIA system during bone surgery. The 227 reports mostly describe shafts breaking, sometimes leaving metal fragments in the patient. The reports include 27 injuries and 1 death. 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
227
Deaths reported
1
Injuries reported
27
Recalls naming it
0

Summary

The FDA's MAUDE database contains 227 adverse event reports that list this exact device (DI 10886982189042), received between Dec 21, 2016 and Mar 8, 2024 — classified as 1 death, 27 injuries, 199 malfunctions.

The most frequently reported specific device problem is “Break” (217 reports).

18 other recalls cover devices cleared under the same FDA submission (K013527, K042899); 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: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break217
  • Material Fragmentation9
  • Entrapment of Device8
  • Device-Device Incompatibility2
  • Failure to Advance2
  • Material Integrity Problem2
  • Mechanical Jam2
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • No Consequences Or Impact To Patient67
  • No Patient Involvement55
  • No Known Impact Or Consequence To Patient38
  • No Clinical Signs, Symptoms or Conditions36
  • No Code Available21
  • Foreign Body In Patient12
  • Device Embedded In Tissue or Plaque2
  • Failure of Implant2

Recent adverse event reports

The 25 most recent of 227 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 8, 2024Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT BONE TRANSPLANTING FOR FEMORAL FRACTURE WITH NONUNION. A DRIVESHAFT WAS BEING OPERATED, A LOCKING CLIP CAME OFF. THE DRIVESHAFT WAS PERFORMED WHILE IT WAS BEING HELD BY HAND. WHILE A GRAFT FILTER WAS WORKING FOR ABSORPTION AND COLLECTION, MORE THAN 4 PIECE OF METAL FRACTIONS WERE DISCOVERED INSIDE OF THE GRAFT FILTER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IT WAS ASSUMED THAT THE APPROACH OF HOLD FOR A GRAFT FILTER BY HAND WAS OUT OF REGULAR APPROACH, SO A CONNECTION FUNCTION WORKED UNWELL, AND ITSELF DID NOT LAST EFFECTIVE, AND THUS SUCH SITUATION TRIGGERED THE DRIVESHAFT¿S TIP MIGHT HAVE BEEN BROKEN OFF. NO DAMAGED REAMER PORTION WAS CONFIRMED. UNDER IMAGE INTENSIFIER¿S OBSERVATION, NO METAL FRACTION IN MEDULLARY CAVITY WAS CONFIRMED. PLUS, THERE WAS CONFIRMED NO REMAINS IN PATIENTS¿ BODY THROUGH POSTOPERATIVE X-RAY PHOTOS. THIS REPORT IS FOR DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18866602 ↗
  • MalfunctionOct 19, 2023Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE TIP PART IS BROKEN. ISSUE AN UNREPAIRABLE LETTER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) RIA DRIVESHAFT L520. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 17966916 ↗
  • MalfunctionApr 20, 2023Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COSTA RICA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, INTRAMEDULLARY REAMING WAS BEING PERFORMED USING THE RIA SYSTEM TO WASH AND TAKE A CULTURE BECAUSE THE PATIENT HAD OSTEOMYELITIS. DURING THE REAMING THE TRANSMISSION SHAFT WAS DAMAGED. THE BROKEN FRAGMENT WAS REMOVED FROM THE PATIENT. THE SURGERY TOOK LONGER BECAUSE DOCTOR HAD TO USE OTHER EQUIPMENT TO REAM THE PATIENT'S CHANNEL. THIS REPORT INVOLVES ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16775466 ↗
  • MalfunctionMar 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE RIA WAS ASSEMBLED WITH THE RIA 360 DRIVE SHAFT AND THE 12MM TRIMMING HEAD, WHICH BROKE AT THE MOMENT OF REAMING THE FEMORAL CANAL. AFTERWARD, THEY PASSED THE 13MM TRIMMING HEAD WHICH WAS MOUNTED ON THE RIA 520 TO CONTINUE THE EXTRACTION OF GRAFT FROM THE CANAL. THE HEAD AND PROXIMAL PART OF THE DRIVING SHAFT WERE SPLIT AGAIN. IT WAS NOT POSSIBLE TO REMOVE THE HOSE SYSTEM OF THE RIA L360 FROM ITS DRIVE SHAFT, SO IT WAS COVERED WITH LATEX GLOVES. THE PROCEDURE WAS NOT A SUCCESS. THE SURGEON WAS NOT ABLE TO REMOVE THE REQUIRED GRAFT AND THE WOUND WAS CLOSED. DUE TO THE DAMAGE OF THE TWO MILLING CUTTERS AND THE DRIVE SHAFT, IT WAS NOT POSSIBLE TO TAKE THE GRAFT THAT THE PATIENT NEEDED TO FILL THE DEFECT BECAUSE IT WAS A RECONSTRUCTIVE SURGERY THAT REQUIRED A SECOND SURGICAL TIME, WITH THE POSSIBILITY AND RISK OF INFECTION. IT WAS DISCOVERED UPON INSPECTION OF THE RETURNED PRODUCT ON MARCH 8, 2023 THAT THE TIP OF THE RIA DRIVESHAFT L520 BROKE OFF. THIS REPORT INVOLVES ONE DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16597927 ↗
  • MalfunctionMar 6, 2023Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE INSPECTION IN THE ORTHO KIT LOANER DEPARTMENT AT LOC UMKIRCH, PRODUCT DEVIATION WAS IDENTIFIED. THE TIP OF THE RIA DRIVESHAFT WAS BROKEN. NO PATIENT IMPACT AND NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16485565 ↗
  • MalfunctionFeb 24, 2023Break; Break

    DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRIVER SHAFT IN QUESTION WAS FOUND TO BE BROKEN DURING INSPECTION AT THE ORTHOKIT LOANER DEPARTMENT. THERE WAS NO REPORTED PATIENT IMPACT, THE EVENT WAS DISCOVERED OUTSIDE OF SURGERY. THIS REPORT IS FOR A DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16435956 ↗
  • MalfunctionJan 18, 2023No Apparent Adverse Event; No Apparent Adverse Event

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE END OF THE L360 DRIVE SHAFT AND THE LEGS OF THE 12 MM RIA MILLING CUTTER SPLIT. PARTICLES REMAINED IN THE CHANNEL. THERE WAS A 30-MINUTE DELAY IN RELATION TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED, AND THE PATIENT STATUS/OUTCOME WAS REPORTED AS OK. A FRAGMENT REMAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16195904 ↗
  • MalfunctionJul 7, 2022Break; Break

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT THE RIA DRIVE SHAFT WAS BROKEN PREOPERATIVELY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14949412 ↗
  • MalfunctionJun 21, 2022Break; Break

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE REAMER DEVICE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE RIA DRIVESHAFT L520 DEVICE. THIS COMPLAINT INVOLVES ONE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14755590 ↗
  • MalfunctionJun 2, 2022Break; Break

    DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE LOCKING CLIP WOULD NOT COUPLE TO THE REAMER/IRRIGATOR/ASPIRATOR (RIA) HOSE. ADDITIONALLY, THE TIP OF THE RIA DRIVE SHAFT BROKE AND LEFT TRACES OF THE TIP IN THE RIA FILTER. THIS REPORT IS FOR A DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14576184 ↗
  • MalfunctionMay 10, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED AT THE END I SEE Q THE DRIVE SHAFT TIP WAS BROKEN. THIS COMPLAINT INVOLVES ONE (1) DEVICES RIA DRIVESHAFT L520. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14348068 ↗
  • MalfunctionMay 9, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: WHEN PULLING OUT THE DRIVE SHAFT, IT WAS OBSERVED THAT THE TIP BROKE. THIS COMPLAINT INVOLVES ONE (1) DEVICE DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14338342 ↗
  • MalfunctionApr 21, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING THE SURGERY, WHEN USING THE PIECE OF THE TRANSMISSION SHAFT INSTRUMENTATION WHEN ASSEMBLING THE STERILE IMPLANTS, THE SYSTEM OF HOSES AND DRILLS, THESE DID NOT BLOCK IN THE SYSTEM BECAUSE THE MENTIONED TRANSMISSION SHAFT IS DAMAGED, AT THE TIP THERE IS EVIDENCE OF A SPLIT WHICH CAUSED IT TO BE DAMAGED. THE STRAWBERRY AND THEREFORE DID NOT WORK FOR ITS USE; THE SURGEON, DISSATISFIED WITH THE DELAY IN SURGERY, ASKS TO USE OTHER STERILE IMPLANTS TO BE ABLE TO FINISH THE PROCEDURE, CLARIFYING NOT TO CHARGE FOR THESE DUE TO THE POOR CONDITION OF THE PIECE THAT CAUSES THEIR DAMAGE SO THAT THEY CANNOT BE USED PROPERLY IN THE FIRST INSTANCE. HOWEVER, THE OTHER PIECE OF INSTRUMENTS IS IN GOOD CONDITION AND THE SURGERY COULD BE COMPLETED WITHOUT COMPLICATIONS FOR THE PATIENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE RIA DRIVESHAFT L520. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14174296 ↗
  • MalfunctionApr 21, 2022Break; Break

    THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNKNOWN SURGERY OF THE FEMUR ON (B)(6) 2022, IT WAS OBSERVED THAT THE REAMER HEAD AND DRIVE SHAFT DEVICES BROKE DURING REAMING OF THE PATIENT'S FEMUR. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT WAS REPORTED TO BE FINE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA DEVICE. THIS COMPLAINT INVOLVES 2 DEVICES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14167710 ↗
  • MalfunctionMar 12, 2022Break

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 THE TIP OF THE TRANSMISSION SHAFT WAS BROKEN. THERE WAS NO PATIENT IMPACT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13743175 ↗
  • MalfunctionFeb 23, 2022Break; Break

    IT WAS REPORTED THAT ON UNKNOWN DATE, THE UNIVERSAL CHUCK WITH T-HANDLE AND DRIVE SHAFT WERE BROKEN FROM USAGE DURING AN UNKNOWN PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13585367 ↗
  • MalfunctionFeb 23, 2022Break; Break

    IT WAS REPORTED THAT ON UNKNOWN DATE, ONE (1) PELVIC REDUCTION FORCEP, ONE (1) LISS INSERTION GUIDE FOR DISTAL FEMUR, ONE (1) DEPTH GAUGE FOR LOCKING SCREW, FOUR (4) UNIVERSAL CHUCK WITH T-HANDLE, ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER, ONE (1) PELVIC REDUCTION FORCEP, TWO (2) RIA DRIVE SHAFT, ONE (1) BENDING PLIERS, ONE (1) FORCEP FOR BROKEN SCREW REMOVAL, ONE (1) LOCKING PLIER, TWO (2) LARGE QUICK COUPLING, ONE (1) DEPTH GAUGE, ONE (1) SILICONE HANDLE, ONE (1) RED FORCEPS SERRATED JAW RATCHET, ONE (1) PLATE HOLDING FORCEP, ONE (1) REDUCTION FORCEP WITH POINT RATCHET, ONE (1) HOLDING SLEEVE WITH WING SCREW, ONE (1) GRAPHIC CASE AND TWO (2) GRAPHIC CASE FOR SCREW REMOVAL SET WERE BROKEN FROM USAGE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 9 OF 16 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13584710 ↗
  • MalfunctionFeb 22, 2022Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2021, THE RIA REAMER TIP WAS DAMAGED. NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13581128 ↗
  • MalfunctionFeb 17, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE END OF THE RIA DRIVE SHAFT WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13552223 ↗
  • MalfunctionFeb 16, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE REAMER IRRIGATOR ASPIRATOR(RIA) METAL SHAFT BROKE INSIDE THE CANAL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) RIA DRIVESHAFT L520. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13545936 ↗
  • MalfunctionJan 31, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE DRILL BIT OF THE ESTUARY HOSE SPLIT AFTER THE GRAFT EXTRACTION FINISHED. THIS REPORT INVOLVES ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13397879 ↗
  • MalfunctionJan 14, 2022Break; Break

    IT WAS REPORTED THAT, THE REAMER IRRIGATOR ASPIRATOR (RIA) TUBE ASSEMBLY, FOR RIA DRIVE SHAFT HAD A BREAK AT THE TIP. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13259656 ↗
  • MalfunctionDec 14, 2021Break; Break

    IT WAS FURTHER REPORTED THAT NO FRAGMENT REMAINED IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13005719 ↗
  • MalfunctionDec 13, 2021Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A FEMUR PROCEDURE, THE 12.0MM REAMER HEAD BROKE. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12984348 ↗
  • MalfunctionOct 5, 2021Break; Break

    IT WAS FURTHER REPORTED THAT THE RIA DRIVE SHAFT HAS PRESENTED A DYSFUNCTION. IT WAS EITHER TOO LATERAL TO ENTRY POINT AND/OR THERE WAS AN INCORRECT POSITIONING OF THE RELIEF HEAD. THE PATIENT OUTCOME IS REPORTED AS GOOD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12576631 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013527, K042899. One submission often covers many models, so check the product and lot details in each record.

  • Z-1237-2024 · Jan 24, 2024 · Open, Classified
    RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effective
  • Z-0572-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
  • Z-0579-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
  • Z-0577-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
  • Z-0583-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
  • Z-0582-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
  • Z-0580-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
  • Z-0574-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
  • Z-0586-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
  • Z-0576-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
  • Z-0573-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
  • Z-0571-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
  • Z-0585-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
  • Z-0578-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
  • Z-0587-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S

…and 3 more.

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