MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WIRE BAY PT CORT 370 MM; PIN, FIXATION, THREADED

Catalog Number	102102
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).Note: this is the second wire breakage event experienced by the patient.The first event was reported to fda under manufacturer report number: 1020279-2023-02246.
Event or Problem Description
It was reported that, during ilizarov external fixation treatment, the patient experienced breakage of the wire bay pt cort 370 mm.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.It is unknown if/when wire replacement was conducted.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical medical investigation stated that no clinical documentation has been provided; however, the broken wires (reported as one wire bayonet point cortical and one wire with stopper) were used with conventional ilizarov slotted bolt and smart fx struts on two rings.Precautions and adverse effects are noted in the smith and nephew external fixation systems important medical information and cautions to check wire security and tension and includes loosening/breakage, reoperation, and excessive motion at the fracture site.Although loose and or broken transosseous wires may increase the risk for instability, infection, and a less than optimal therapeutic outcome; it was communicated that the patient is healing as expected, weight-bearing, is not neuropathic and remains in treatment.Based on the limited information provided, no further assessment or conclusion can be made regarding definitive contributing factors to the event and the patient impact beyond the revision due to the wire breakages with resumed therapy cannot be determined.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 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 this product and event.According to the inspection procedure, a verification of the part per print must be performed within the steps of the final inspection.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique, postoperative care, patient anatomy and/or excessive forces.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.
Additional Manufacturer Narrative
H11 - corrected data: b5 - describe event or problem.
Event or Problem Description
It was reported that, during ilizarov external fixation due to due to pilon fracture, the patient experienced breakage of the wire bay pt cort 370 mm.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 returned to the operating theatre to receive broken fixation replacement on an unknown date, and is healing as expected, weight-bearing, and is not neuropathic.Patient is still in treatment.

• Brand Name: WIRE BAY PT CORT 370 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: 18234277
• Report Number: 1020279-2023-02350
• Device Sequence Number: 11589561
• Product Code: JDW
• UDI-Device Identifier: 03596010031204
• UDI-Public: 03596010031204
• 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
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2023

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: 102102
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 12/21/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/18/2023; 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown