MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OBTURATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71674078
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Event or Problem Description
It was reported, that during surgery, while drilling for the lag screw.The obturator broke trying to keep the guide in place.Portion of instrument that broke was not inside the patient.The 3.2mm t-handle trocar was used in place of the obturator.The procedure was resumed, without any delay, changing the surgical technique.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that the obturator broke trying to keep the guide in place.As this instrument is always used outside the patient, breakage may cause minor or temporary injury (e.G.Abrasion, laceration, etc.) requiring no or minor medical intervention, for which this issue does not meet the criteria to be reportable.Moreover, if the device malfunction were to recur, the event may result in a short procedural delay or require use of a backup device to continue procedure, and would not be likely to cause or contribute to a death or serious injury.H11 ¿ corrected data.B5- describe event or problem.
Event or Problem Description
It was reported that during internal fixation surgery, while drilling for the lag screw, the obturator broke trying to keep the guide in place.The instrument was not inside the patient.Surgery was resumed, without any delay, with a back-up instrument: the 3.2mm t-handle trocar was used in place of the obturator.Patient was not injured as consequence of this problem.

• Brand Name: OBTURATOR
• Common Device Name: ORTHOPEDIC MANUAL 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: 17084151
• Report Number: 1020279-2023-01243
• Device Sequence Number: 16837513
• Product Code: LXH
• UDI-Device Identifier: 03596010560742
• UDI-Public: 03596010560742
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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 Model Number: 71674078
• Device Catalogue Number: 71674078
• Device Lot Number: 492912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/11/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown