MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0MM DRILL BIT W/ QC - 157MM; PLATE, FIXATION, BONE

Model Number	71174905
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during surgery, at the time of drilling the 1.8mm drill short w/ao qc broke into two parts.No pieces fell into patient.The procedure was resumed, after a non-significant delay, using a competitor's device.Patient was not injured as consequence of this problem.
Event or Problem Description
It was reported that, during surgery, at the time of drilling the 2.0mm drill bit w/ qc - 157mm broke into two parts.No pieces fell into patient.The procedure was resumed, after a non-significant delay, using a competitor's 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 broke into two pieces.Both pieces were returned.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.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 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: 2.0MM DRILL BIT W/ QC - 157MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 16579988
• Report Number: 1020279-2023-00595
• Device Sequence Number: 14000499
• Product Code: HRS
• UDI-Device Identifier: 03596010608161
• UDI-Public: 03596010608161
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 71174905
• Device Catalogue Number: 71173588
• Device Lot Number: 18JNG0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 05/08/2023; 05/25/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/17/2023; 05/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 56 KG