MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL 2.5MM DRILL W/AO QC LONG; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	71175022
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3,h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 submitting this report in accordance with applicable regulations.If additional investigative findings or 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 a left tibia and fibula internal fixation, the 2.5mm drill bit tip measuring 3cm broke into the left tibia while surgeon was using drill bit for procedure.Surgeon attempted to remove drill bit, but was unsuccessful at removing from patient's bone.It is unknown how the surgery was completed or if this caused a surgical delay.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H6: type of investigation.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 the root cause of the reported issue cannot be determined.Although a procedural variance could not be ruled out.The evos drill is comprised of 17-4 ph stainless steel.The drill is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.Micro-motion or movement is unlikely as it was reported that the bit was left in the patient¿s bone.There is potential risk for tissue inflammation and/or pain.The patient impact beyond the reported device breakage and retained foreign body could not be definitively determined, since it was not reported how the procedure was completed, if there was a procedural delay nor was the patient¿s health reported.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 instructions for care, maintenance, cleaning, and sterilization of smith & nephew orthopedics devices for single-use devices revealed that as the devices are sold both nonsterile and sterile and often removed from their original packaging to be placed in a containment device they should be cleaned and/or inspected prior to sterilization.The device should not be reprocessed or reused if comes in contact with blood, tissue or bodily fluids.Reuse may increase risk of breakage, failure, patient infection, patient injury and revision surgery.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.H6: health effect - clinical code.

• Brand Name: EVOS SMALL 2.5MM DRILL W/AO QC LONG
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 20950453
• Report Number: 1020279-2024-02686
• Device Sequence Number: 8196021
• Product Code: HWE
• UDI-Device Identifier: 00885556635766
• UDI-Public: 885556635766
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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 Catalogue Number: 71175022
• Device Lot Number: UNKNOWN
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male