MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WIRE WITH STOPPER 400 MM; PIN, FIXATION, THREADED

Catalog Number	102107
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during ilizarov external fixation treatment, the patient experienced two (2) wire breakages on (b)(6) 2023.The wires were replaced.The tsf configuration is two rings, three pins proximally, no adverse observations.Wire fixation bolt used are conventional ilizarov slotted bolt and the struts on the frame were smart fx struts.The patient is healing as expected, weight-bearing, and is not neuropathic.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, responses to the requested clinical information have not been provided and the indication for the external fixation is unknown.It is important the appropriate construct type and size are selected based on the injury, weight and indication.The product complaint form lists the component as a 1.8 olive wire with stopper and indicated no injury to the patient occurred, noting the procedure was finished with a smith and nephew backup device.Based on the limited information provided, the patient impact was likely limited to the wire breakages and use of backup devices, as no adverse observations were reported and the patient is reportedly weight-bearing, not neuropathic and healing as expected.The devices' batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for external fixation systems revealed that breakage of the pins, wires, or other components including inadvertent injury to the patient or operating room personnel caused by the wire (e.G.Projective wire from tip cutting during surgery) has been identified as an adverse effect.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 these products and event.According to the material specification, the quality and manufacture of special quality stainless steel bar, strip and coil stock shall be controlled.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique and/or excessive forces.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.
Additional Manufacturer Narrative
H11: corrected data.H6: evaluation codes: f code corrected.

• Brand Name: WIRE WITH STOPPER 400 MM
• Common Device Name: PIN, FIXATION, THREADED
• 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: 18145255
• Report Number: 1020279-2023-02246
• Device Sequence Number: 17861251
• Product Code: JDW
• UDI-Device Identifier: 03596010031259
• UDI-Public: 03596010031259
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K994143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2024

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: 102107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/14/2023; 01/09/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/19/2023; 01/15/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown