MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.5MM X 3.5MM DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	71175041
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a clavicle orif, the evos 2.5mm x 3.5mm drill guide came apart while drilling into bone.The evos small 2.5mm drill w/ao qc short was also stuck in the guide.Surgery was performed after a non-significant delay, with a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
H3, h6: the associated devices were returned and evaluated.The visual inspection and functional evaluation revealed that the drill guide attachment (30 mm) is not fractured but is stuck on the drill bit.With the drill bit being stuck inside the drill guide attachment, the piece seemed to be unscrewed from the drill guide handle.All parts have been returned.The visual also revealed indications of wear and use.The device is not functional.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the drill guide, a review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.For the drill bit, a review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management files for both devices 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 products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.The drill guide is a reusable instrument that can be exposed to numerous surgeries.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The drill bit is a single use device; therefore, surgical technique, damage from misuse, rough handling and damage from prolonged use of the drill guide are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.Should 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: EVOS 2.5MM X 3.5MM DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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: 19012826
• Report Number: 1020279-2024-00639
• Device Sequence Number: 14458178
• Product Code: FZX
• UDI-Device Identifier: 00885556636404
• UDI-Public: 00885556636404
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: 71175041
• Device Lot Number: 17MSC001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71175023 / LOT: 23FUQ0033
• Patient Sex: Unknown