MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 6.4MM DRILL; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71631160
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during drilling at the femoral head, the end of one (1) 6.4mm drill broke.The broken piece could not be removed and remained in the bone.However, there was no effect on the insertion and screwing of the proximal screws.It is unknown whether there was a delay or how the surgery was completed.Patient´s current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited information provided, there were no clinical factors presented which would have contributed to the event.The 6.4mm drill material is stainless steel and is not intended for long term internal exposure and long-term implantation data is not available.The patient impact beyond the retained foreign body which reportedly ¿remained in the bone¿ cannot be determined; however, possible micro-motion and/or migration, local irritation/discomfort and/or corrosion cannot be ruled out.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 for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for care, maintenance, cleaning and sterilization revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.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 product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.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: 6.4MM DRILL
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 16048662
• Report Number: 1020279-2022-05064
• Device Sequence Number: 15007273
• Product Code: KTT
• UDI-Device Identifier: 03596010419682
• UDI-Public: 03596010419682
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71631160
• Device Catalogue Number: 71631160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 12/26/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown