MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 9.0MM FIXED ENDCUTTING RMR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71118226
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the osteosynthesis procedure, the 9.0mm fixed endcutting rmr broke off when the medullary canal was finished.The procedure was resumed, without any delay, using a s+n back-up device.Oncologic patient, diagnosed with breast cancer, during the procedure went into cardiac arrest and after seven attempts of resuscitation died in the operating room due to natural causes, not due to a device related failure.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during the osteosynthesis procedure, the 9.0mm fixed endcutting rmr broke off when the medullary canal was finished.The pieces fell inside the patient.The device broke in two and did not remain inside the canal.It managed to get out by retracting the engine, and the piece was grabbed with rochester forceps.The procedure was resumed, without any delay, using a s+n back-up device.Oncologic patient, diagnosed with breast cancer, during the procedure went into cardiac arrest and after seven attempts of resuscitation died in the operating room due to natural causes, not due to a device related failure.
Additional Manufacturer Narrative
H2: additional information ¿h6: health effect - impact code.H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The photographs were reviewed, and did not provide any insight relative to the failure mode or the root cause of the alleged failure.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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 evidence to conclude 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: 9.0MM 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: 20335262
• Report Number: 1020279-2024-01977
• Device Sequence Number: 7836260
• Product Code: JDG
• UDI-Device Identifier: 03596010436597
• UDI-Public: 3596010436597
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

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 Catalogue Number: 71118226
• Device Lot Number: 21CM23945
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 10/24/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/09/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 85 KG