MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 10MM FIXED ENDCUTTING RMR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71118228
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).
Event or Problem Description
It was reported that, while reaming the medullary canal in an intramedullary nail procedure, the 10mm fixed endcutting rmr broke inside the medullary canal.Pliers were requested and with the help of the impactor was removed from the medullary canal.This caused a 40 minute delay in the procedure.Then a olive guide was requested to introduce the nail into the bone.When the guide was going to be removed, it did not pass through the nail because the guide was too thick.The surgeon had to retrieved the nail with the guide and then he inserted the nail into the bone without the guide.Additionally, the arc of nail insertion was descalibrated, therefore, the drill bits didn't coincide exactly with the holes in the nail.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.However, the photographs were reviewed, and revealed the fracture.The device was fractured along the shaft.The clinical/medical investigation concluded that, the two unlabeled intra-operative images dated (b)(6) 2023, confirm the reamer breakage, however, they do not aid in determining the definitive root cause of the reported failure.Based on the information provided, the surgeon chose the no.10mm reamer to place the 10/8.5x8cm resulting in the reamer breakage inside of the medullary canal.The surgical technique for the trigen humeral nail recommended that all the nail sizes taper, and the canal should be reamed to 1mm larger than the implant diameter but after the broken reamer was removed it was not stated if there was continued reaming for the 10/8.5x8cm nail as directed.The misalignment with the holes in the nail is likely a result of the surgeon¿s report that the arc of nail insertion was decalibrated, therefore, the drill bits didn't coincide exactly with the holes in the nail.Therefore, we are unable to confirm whether adequate fracture reduction or proper alignment was achieved.It cannot be concluded the impact beyond the reported the surgical delay of approximately 40 minutes.The future impact beyond what is being reported cannot be concluded at this time.Therefore, no further clinical/medical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 10MM FIXED ENDCUTTING RMR
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16717338
• Report Number: 1020279-2023-00792
• Device Sequence Number: 1609777
• Product Code: JDG
• UDI-Device Identifier: 03596010436610
• UDI-Public: 03596010436610
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71118228
• Device Catalogue Number: 71118228
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male