MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE DRILL 35MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71362935
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during tha, a flexible drill 35mm bent and broke off inside the patient, making it unusable.The piece was removed completely from the patient.There was no delay and the procedure was finished using the same device.No patient injury was reported as consequence of this event.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.However, a review concluded that the event reported under this complaint was previously identified.It was concluded that the root cause of this issue was the shaft was not strong enough to resist high torques before failure of the shaft.The action taken was to add additional wires to the flexible shaft to make it stronger to resist higher torques.A review of complaint history of the previous 12 months revealed similar events for this part number with batches that were manufactured before and after the change of the device design.Therefore, an additional action, that is still in progress, was indicated to address the flexible shaft breakages/bending/pig-tailing, drill tip breakages/bending and drill tip not advancing properly into the bone.The device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The clinical/medical investigation concluded that, as of the date of this investigation, no additional supporting documentation has been received or made available for review.Therefore, a thorough medical investigation could not be rendered.The report stated the surgeon was able to remove the broken piece completely from inside of the patient and complete the procedure with the same device.No harm has been alleged to this patient as a consequence of this adverse event.At this time, we have no evidence to suspect that the product failed to meet any specifications at the time of manufacture.Instrument design is the most probable root cause that could contribute to the reported event.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: FLEXIBLE DRILL 35MM
• 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: 19727399
• Report Number: 1020279-2024-01357
• Device Sequence Number: 8327945
• Product Code: JDG
• UDI-Device Identifier: 03596010464668
• UDI-Public: 03596010464668
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 08/13/2024

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: 71362935
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female