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	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a thr surgery, a flexible drill 25m was noticed fractured.The procedure was resumed, after a non-significant delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the device is fractured.The device exhibits signs of significant wear/ usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a review determined 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 the flexible screw drill part numbers with batches that were manufacture before and after the change of the device design.Therefore, an additional action was indicated to address the flexible shaft breakages/bending/pig-tailing, drill tip breakages/bending and drill tip not advancing properly into the bone.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Instrument design is the most probable root cause that could contribute to the reported event.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor 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: 17455670
• Report Number: 1020279-2023-01545
• Device Sequence Number: 7152960
• Product Code: JDG
• UDI-Device Identifier: 03596010463272
• UDI-Public: 03596010463272
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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 Catalogue Number: 71362925
• Device Lot Number: 21MSC0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown