MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE DRILL 25MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71362925
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr surgery, one (1) flexible drill 25mm was broken.The procedure was resumed, without any delay, using the same device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, the flex drill was broken during a total hip replacement; however, the procedure was reportedly resumed without delay, using the same device without report of patient injury.Reportedly, while using the drill on the acetabulum, it broken, not staying attached to the bone but fixed to the motor itself and the surgery was completed successfully.As of the date of this medical investigation, no response to requests letters have been provided.Based on the limited information provided, no clinical factors were concluded to have definitively contributed to the event.No further patient impact would be anticipated as it was reported that the procedure was successfully completed using the same device.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 is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.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: FLEXIBLE DRILL 25MM
• 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: 19653733
• Report Number: 1020279-2024-01275
• Device Sequence Number: 6623869
• Product Code: JDG
• UDI-Device Identifier: 03596010463272
• UDI-Public: 03596010463272
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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
• Device Catalogue Number: 71362925
• Device Lot Number: 23ASC0009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female